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Manipulative Therapy for Lower Extremity Conditions: Expansion of Literature Review

      Abstract

      Objective

      The purpose of this study was to conduct a systematic review on manipulative therapy for lower extremity conditions and expand on a previously published literature review.

      Methods

      The Scientific Commission of the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) was charged with developing literature syntheses, organized by anatomical region, to evaluate and report on the evidence base for chiropractic care. This article is the outcome of this charge. As part of the CCGPP process, preliminary drafts of these articles were posted on the CCGPP Web site www.ccgpp.org (2006-8) to allow for an open process and the broadest possible mechanism for stakeholder input. The Cumulative Index to Nursing and Allied Health Literature; PubMed; Manual, Alternative, and Natural Therapy Index System; Science Direct; and Index to Chiropractic Literature were searched from December 2006 to February 2008. Search terms included chiropractic, osteopathic, orthopedic, or physical therapy and MeSH terms for each region. Inclusion criteria required a diagnosis and manipulative therapy (mobilization and manipulation grades I-V) with or without adjunctive care. Exclusion criteria were pain referred from spinal sites (without diagnosis), referral for surgery, and conditions contraindicated for manipulative therapy. Clinical trials were assessed using a modified Scottish Intercollegiate Guidelines Network ranking system.

      Results

      Of the total 389 citations captured, 39 were determined to be relevant. There is a level of C or limited evidence for manipulative therapy combined with multimodal or exercise therapy for hip osteoarthritis. There is a level of B or fair evidence for manipulative therapy of the knee and/or full kinetic chain, and of the ankle and/or foot, combined with multimodal or exercise therapy for knee osteoarthritis, patellofemoral pain syndrome, and ankle inversion sprain. There is also a level of C or limited evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for plantar fasciitis, metatarsalgia, and hallux limitus/rigidus. There is also a level of I or insufficient evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for hallux abducto valgus.

      Conclusions

      There are a growing number of peer-reviewed studies of manipulative therapy for lower extremity disorders.

      Key Indexing Terms

      In 2006, Hoskins et al
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      published the first extensive review of chiropractic treatment of lower extremity conditions. Building upon these efforts and using similar methodology and structure, the present study represents an expanded and updated systematic review. While acknowledging the earlier study, the conclusions in this article are solely those of the included Council on Chiropractic Guidelines and Practice Parameters (CCGPP) subcommittee authors.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      In the Hoskins et al review, chiropractic treatment was operationally defined as some form, technique, or procedure using applied manipulative therapy (manipulation, mobilization, and/or other manual or functional procedures) with and without adjunctive treatment. For the purposes of this updated and expanded literature review, chiropractic has been replaced by the term manipulative therapy to facilitate inclusion of all literature from accessible peer-reviewed sources.

      Peterson D, Bergmann T. Chiropractic technique: principles and procedures. 2nd ed. St. Louis, Missouri: Mosby; 2002. p. 97-169,184.

      Although the public generally associates chiropractic primarily with the treatment of back pain, only a minority of practitioners perceive themselves solely as spine specialists.
      • Christensen M
      • Kollasch M
      • Ward R
      • Kelly R
      • Day A
      • zumBrunnen J
      The data demonstrate that most chiropractors, based upon their professional training, routinely diagnose and treat extremity conditions. It is of importance to the chiropractic profession to elevate the awareness of the general public, government, third-party payers, as well as other stakeholders regarding the training and competency of chiropractors to care for extremity conditions. Although chiropractors can easily document the use of manipulative therapy (with and without adjunctive treatment) for lower extremity neuromusculoskeletal problems and disorders for 100 years, other health care providers, such as physical therapists, general and family physicians, and acupuncturists, are more commonly recognized as able to care for the axial and appendicular neuromusculoskeletal system.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Nelson C
      • Lawrence D
      • Triano J
      • et al.
      Chiropractic as spine care: a model for the profession.
      • Finn AM
      • MacAirt J
      A survey of the work practices of physiotherapists in the community.
      • Cherkin DC
      • Sherman KJ
      Acupuncture and knee osteoarthritis.
      • Brantingham JW
      • Snyder WR
      Old Dad Chiro and extravertebral manipulation.
      • Wardwell W
      • Keating J
      • Brantingham J
      • Donahue J
      • Brown R
      • Toomey W
      A brief history of manipulative foot care in America.
      Depending upon the source, upper and lower extremity problems have been reported to account for up to 20% of all of chiropractic care, with lower extremity pain and injury specifically accounting for up to 10% of common chiropractic practice and with most practitioners using extremity manipulative therapy based upon location, methodology, training, and philosophy.
      • Christensen M
      • Kollasch M
      • Ward R
      • Kelly R
      • Day A
      • zumBrunnen J
      • Nelson C
      • Lawrence D
      • Triano J
      • et al.
      Chiropractic as spine care: a model for the profession.
      • Barnes P
      • Powell-Griner E
      • McFann K
      • Nahin R
      Complementary and alternative medicine use among adults: United States, 2002.
      • Pollard H
      • Hoskins W
      • McHardy A
      • et al.
      Australian chiropractic sports medicine: half way there or living on a prayer?.
      • Metz RD
      • Nelson CF
      • LaBrot T
      • Pelletier KR
      Chiropractic care: is it substitution care or add-on care in corporate medical plans?.

      Brantingham J. Foundational studies in manipulative therapy for lower extremity neuromusculoskeletal disorders [PhD dissertation]. European Institute of Health and Medical Sciences, University of Surrey, Guildford, England; 2005.

      • Mootz R
      • Cherkin D
      • Odegard C
      • Eisenberg D
      • Barassi J
      • Deyo R
      Characteristics of chiropractic practitioners, patients, and encounters in Massachusetts and Arizona.
      • Cherkin D
      • Deyo R
      • Sherman K
      • et al.
      Characteristics of visits to licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians.
      This contrasts to treatment of nonmusculoskeletal conditions such as chest, abdominal pain, and wellness (5.3%, 3.7%, and 8.0%, respectively).
      • Christensen M
      • Kollasch M
      • Ward R
      • Kelly R
      • Day A
      • zumBrunnen J
      • Nelson C
      • Lawrence D
      • Triano J
      • et al.
      Chiropractic as spine care: a model for the profession.
      Extremity treatment is the second most frequently applied procedure within the chiropractic profession, with 76.1% reportedly using spinal and extremity procedures as compared with 18.7% who limit their practice to the spine only.
      • Christensen M
      • Kollasch M
      • Ward R
      • Kelly R
      • Day A
      • zumBrunnen J
      Indeed, chiropractic academic curriculums are directed toward neuromusculoskeletal disorders associated with the full appendicular (including axial) skeleton and include training in anatomy, biomechanics, differential diagnosis, radiology, radiographic positioning, orthopedics, sports medicine, first aid, rehabilitation, and extremity diagnosis and treatment.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      Certainly, based upon academic training, the current chiropractic graduate is well qualified to manage disorders.
      Further exemplifying the chiropractic profession's contribution as the forerunner to extremity care, in a recent 2004 trial of high-velocity, low-amplitude (HVLA) axial elongation thrust manipulation of the hip conducted to determine efficacy in treatment of hip osteoarthritis (including grade 4 radiographic degeneration with severe pain and stiffness), HVLA manipulative therapy was superior to a hip exercise protocol.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • van Baar ME
      • Dekker J
      • Oostendorp RA
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      This trial used the most common, and possibly oldest, chiropractic manipulative procedure used for hip disorders and osteoarthritis over the last century, further supporting previous, preliminary studies and reports completed on and before 2004.

      Palmer B, Palmer D. The science of chiropractic. Davenport: Palmer School of Chiropractic; 1906. p. 14, 358.

      • Palmer D
      • Vaux P
      Hip osteoarthritis: a chiropractic approach.
      • Brantingham J
      • Williams A
      • Parkin-Smith G
      • Weston P
      • Wood T
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      This trial suggests a possible alternative treatment for (1) those who may not or should not have surgery, (2) those who may not or should not chronically use nonsteroidal anti-inflammatory drugs (NSAIDS), and (3) those for whom exercise alone is not effective.
      • Brantingham J
      • Snyder W
      Did osteopathy ‘borrow’ the chiropractic short lever adjustment (the core of all modern manipulation techniques) without giving Palmer credit?.
      • Cyriax J
      • Grieve G
      • Moseley J
      • O'Malley K
      • Petersen N
      • et al.
      A controlled trial of arthroscopic surgery for osteoarthritis of the knee.
      • Lauretti W
      Comparative safety of chiropractic.
      • McGettigan P
      • Henry D
      Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2.
      • Bennell KL
      • Hinman RS
      • Metcalf BR
      • et al.
      Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial.
      • Moss P
      • Sluka K
      • Wright A
      The initial effects of knee joint mobilization on osteoarthritic hyperalgesia.
      Although publications on manipulative therapy in the treatment of peripheral disorders have recently exploded, much more study is required.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Menz H
      Manipulative therapy of the foot and ankle: science or mesmerism?.
      • Guler-Uysal F
      • Kozanoglu E
      Comparison of the early response to two methods of rehabilitation in adhesive capsulitis.
      • Eisenhart AW
      • Gaeta TJ
      • Yens DP
      Osteopathic manipulative treatment in the emergency department for patients with acute ankle injuries.
      • van der Wees P
      • Lenssen AF
      • Hendriks EJ
      • Stomp DJ
      • Dekker J
      • de Bie RA
      Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review.
      Extremity care is not the exclusive domain of any singular health care discipline; and in that spirit, the authors encourage chiropractic, physical therapy, medical, and other disciplines to work collaboratively in the search for improved clinical methods for the treatment of patients with lower extremity conditions.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • Brantingham J
      • Williams A
      • Parkin-Smith G
      • Weston P
      • Wood T
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • Cyriax J
      • Bergmann T
      • Peterson DH
      • Lawrence DL
      In the presence of a rapidly expanding number of research studies as well as growing attention on the usefulness, utilization, and treatment of peripheral disorders through manipulative therapy, the authors believed that it would be helpful to broadly revisit this topic. The purpose of this study is to review the quantity, quality, and types of lower extremity manipulative therapy research published and to rank, grade, and present the characteristics, thus providing a more general, complete, and updated review.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • van der Wees P
      • Lenssen AF
      • Hendriks EJ
      • Stomp DJ
      • Dekker J
      • de Bie RA
      Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review.
      • Zhang W
      • Moskowitz R
      • Nuki G
      • et al.
      OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.

      Methods

      In conjunction with the CCGPP and with input from included authors, an expanded update of the Hoskins et al1 2006 review was undertaken with a search of the literature conducted using the Cumulative Index to Nursing and Allied Health Literature; PubMed; Manual, Alternative, and Natural Therapy Index System; Science Direct; and Index to Chiropractic Literature from December 2006 to February 2008. Limits were set to English language, with abstract, and human studies. Search terms including chiropractic, osteopathic, orthopedic, or physical therapies were searched with MeSH terms for each region. Manipulation or mobilization treatment for the lower extremity was also searched using MeSH terms. For the hip, these included hip injuries, hip dislocation, and hip joint. For the knee, these included the terms knee dislocation, knee injuries, knee joint, collateral, meniscus, and patellofemoral. For the ankle, these included ankle injuries, tarsal bones, and ankle joint lateral ligament. For the foot, the terms were foot bones, foot injuries, foot joint, and interphalangeal. Finally, for the ankle, the terms were ankle injuries, tarsal bones, and ankle joint lateral ligament. In addition to the literature previously reviewed,
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      a further 389 citations were captured from the 4 regions searched: 33 hip, 86 knee, 249 ankle, and 21 foot, respectively.
      After the abstracts were reviewed, the literature was placed into 3 broad categories. Category 1 included randomized controlled or clinical trials (RCTs) with manipulative therapy (with and without adjunctive or multimodal therapy such as exercise/rehabilitation, modalities, NSAIDS, and activity modification, etc).
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      The category 1 evidence table included (1) randomized controlled trials (RCT) that indicate these studies were placebo controlled; (2) randomized clinical trials (RCT^) that denote a comparative study (treatment vs treatment; usually with evidence superior to placebo); (3) controlled or clinical trials (CTs) that are generally pseudo- or nonrandomized (with systematic assignment or purposive allocation) containing a range of controlled variables, diagnosis, manipulative therapy vs placebo, comparative treatment, or both; and (4) studies that are prospective and measurable and that generally include valid and reliable outcome measures with appropriate statistical analyses.
      Category 2 included case series (≥3 patients per study). For case series, the co-chairs of the CCGPP Scientific Commission developed a checklist modified from other instruments. Category 3 included case studies (≤2 patients), but studies not included in the previous review. Inclusion criteria required diagnosis and some variety or mode of manipulative therapy. Articles were excluded when (1) pain was referred from spinal sites (without diagnosis), (2) there was referral for surgical intervention (unless there was documented full postsurgical healing with or without rehabilitation), (3) the condition was not amendable to manipulative therapy (rheumatoid arthritis, fracture, ligament tear with instability, etc), (4) a red-flag diagnosis was identified, or (5) there was a diagnosis absent a description of management or intervention. In the current review, osteopathic, physical therapy, and other types of medical literature were included; however, review-type articles were excluded. Non–peer-reviewed literature, conference proceedings, grand rounds, and discussion articles with no rendered treatment were also excluded.
      Abstraction of data was completed by 3 independent authors using predetermined criteria. Articles were retrieved as hard copy, PDF, or electronic format from the Cleveland Chiropractic College library or from associated library collections. All relevant clinical trials were assessed, reviewed, and ranked using a modified adaptation of the Scottish Intercollegiate Guidelines Network (SIGN) ranking system (instead of the Physiotherapy Evidence Database or “PEDro” scale used in the previous review).
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      • United States Department of Health and Human Services. Agency for Health Care Policy and Research
      General use of SIGN is in conformity to CCGPP systematic reviews. When documenting treatment, standardized terminology was used; therefore, the term manipulative therapy indicated any of the following: (1) all types, methods, modes, techniques, and procedures of mobilization and manipulation grades I through V; (2) all adjustment/adjustive procedures; and (3) manual or manipulative therapy procedures.

      Peterson D, Bergmann T. Chiropractic technique: principles and procedures. 2nd ed. St. Louis, Missouri: Mosby; 2002. p. 97-169,184.

      • Haldeman S
      • Chapman-Smith D
      • Petersen D
      Guidelines for chiropractic quality assurance and practice parameters.
      • Greenman P
      • Maitland G

      The SIGN Scale, Modified Liddle et al Revision, and Limitations of SIGN

      One methodological difference between this and the Hoskins et al 2006 review grew out of CCGPP concerns with the disproportionately inflexible weighting structure represented by singular SIGN components that makes the application to burgeoning areas of historically, weakly supported research, such as the case with manual therapy, difficult at best and was believed to potentially and otherwise mask the helpful information that could be yielded through the assessment of this literature base. Current SIGN checklist and component explanations discard older, previously acceptable randomization techniques, with any noncomputerized randomization completely rejected. The literature supports the appropriateness of the restricted use of manual and mechanical randomization methods, particularly in small samples.

      Domholdt E. Physical therapy research: principles and applications. 2nd ed. Philadelphia: W. B Saunders Company; 2000. p. 98,106.

      • Portney L
      • Watkins P
      • Haneline M
      • Maher CG
      • Sherrington C
      • Herbert RD
      • Moseley AM
      • Elkins M
      Reliability of the PEDro scale for rating quality of randomized controlled trials.
      In addition, SIGN's overemphasis and weighting of a few scale components, excluding all other methodological considerations, are inconsistent with other validated, widely accepted systems such as JADAD or PEDro where randomization and intention to treat analyses (ITAs) are considered as one of a number of important methodological concerns, assigning decreased weight, depressing, not rejecting, overall trial quality.
      • Maher CG
      • Sherrington C
      • Herbert RD
      • Moseley AM
      • Elkins M
      Reliability of the PEDro scale for rating quality of randomized controlled trials.
      • Jadad A
      • Moore R
      • Carroll D
      • et al.
      Assessing the quality of reports of randomized clinical trials: is blinding necessary?.
      In accordance with these above-stated concerns, controlled and clinical trials were ranked using a modified Liddle et al
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      revision of the SIGN scale.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      Whereas the SIGN RCT checklist rates studies as high quality (+), low quality (−), or neutral (n), the modified Liddle et al SIGN scale (Fig 1) uses (++) for high quality with very low risk of bias, (+) for well-conducted studies with low risk of bias, or (−) for studies with few, no, or inadequately fulfilled or described criteria and with high risk for bias.
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      Fig 1SIGN checklist rating (Liddle et al).
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      RatingExplanation
      ++Applies if all or most criteria from the checklist are fulfilled; where criteria are not fulfilled, the conclusions of the study or review are thought very unlikely to alter.
      +Applies if some of the criteria from the checklist are fulfilled; where criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought unlikely to alter.
      Applies if few or no criteria from the checklist are fulfilled; where criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought likely or very likely to alter
      The SIGN revisions of Liddle et al have undergone rigorous development and validation procedures, part of a hierarchy of studies widely accepted as reliable.
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      • United States Department of Health and Human Services. Agency for Health Care Policy and Research
      Furthermore, the SIGN revisions of Liddle et al have been evaluated, adapted, and developed by multiple review groups and assessed for methodological rigor, clarity, and practicality in clinical use (principally for diagnosis but used in this review to rank trials), with studies repeatedly finding their checklists producing reliable and consistent results.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      • United States Department of Health and Human Services. Agency for Health Care Policy and Research
      Some of the trials cited in this expanded review (principally smaller studies) used earlier, noncomputerized randomization procedures then in wide use by various researchers at institutions such as Durban University of Technology in Durban, South Africa, and the University of Surrey in Guilford, England, where much of the pioneering work in lower extremity manipulation research originated. These randomization procedures were accomplished using equal numbers of obscured and folded sheets of paper (eg, 15 or 30 marked A, 15 or 30 marked B), thoroughly mixed to ensure discontinuity, placed in and blindly extracted from a container. At each subject randomization time point, containers were held such that all folded slips were masked; and a slip was drawn out randomly allocating treatment. This older procedure, long used in medicine before accessible, affordable computerized randomization, remains acceptable for samples of N less than or equal to 60 (n ≤ 30 per group).

      Domholdt E. Physical therapy research: principles and applications. 2nd ed. Philadelphia: W. B Saunders Company; 2000. p. 98,106.

      • Portney L
      • Watkins P
      • Haneline M
      Consequently, this review's use of a modified SIGN ranking means manual and mechanical randomization procedures were given decreased methodological weight, indicating lesser quality, but not rejected.
      • Maher CG
      • Sherrington C
      • Herbert RD
      • Moseley AM
      • Elkins M
      Reliability of the PEDro scale for rating quality of randomized controlled trials.
      • Jadad A
      • Moore R
      • Carroll D
      • et al.
      Assessing the quality of reports of randomized clinical trials: is blinding necessary?.
      Evidence-based care, with its hierarchy of evidence, notably includes private practice, field, and expert advice and does not posit care rendered only by evidence from RCTs, as this has been determined to be neither economically feasible, practical, scientific, nor ethical.
      • Haneline M
      With these considerations in mind, this study includes nonrandomized, systematically assigned, controlled or clinical trials (CT) as well as the addition of unlisted or new case series and studies excluded by previous criteria and added in ranked and updated case series and studies sections. In addition, studies using systematic assignment, no longer considered validly randomized, have been included in this review because they frequently used or contain significant innovative methodological controls, concepts, and insights. Such studies, evaluated by the authors as equal to retrospective case series, have been previously treated as if they constitute no evidence at all, discarded as worthless; and incorrectly excluded from the evidence-based hierarchy.
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.

      Domholdt E. Physical therapy research: principles and applications. 2nd ed. Philadelphia: W. B Saunders Company; 2000. p. 98,106.

      • Portney L
      • Watkins P
      • Haneline M
      • Maher CG
      • Sherrington C
      • Herbert RD
      • Moseley AM
      • Elkins M
      Reliability of the PEDro scale for rating quality of randomized controlled trials.
      • Jadad A
      • Moore R
      • Carroll D
      • et al.
      Assessing the quality of reports of randomized clinical trials: is blinding necessary?.
      • Neuhauser D
      • Diaz M
      Shuffle the deck, flip that coin: randomization comes to medicine.
      Arguably, CTs could be placed in category 2; but increased controls within these CTs often markedly exceed typical case series. In comparing against many peer-reviewed published RCTs, with high levels of inadequate, erroneous, and/or incorrect report of per protocol (PP) or ITA as well as disagreement and lack of consensus or standards regarding blinding and blind assessment, there are sufficient justification and rational for inclusion of these RCTs and CTs.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • Eisenhart AW
      • Gaeta TJ
      • Yens DP
      Osteopathic manipulative treatment in the emergency department for patients with acute ankle injuries.
      • Dananberg HJ
      Manipulation of the ankle as a method of treatment for ankle and foot pain.
      • Jennings J
      • Davies G
      Treatment of cuboid syndrome secondary to lateral ankle sprains: a case series.
      • Wyatt LH
      Conservative chiropractic management of recalcitrant foot pain after fasciotomy: a retrospective case review.
      • Crossley K
      • Bennell K
      • Green S
      • Cowan S
      • McConnell J
      Physical therapy for patellofemoral pain. A randomized, double-blinded, placebo-controlled trial.
      • Deyle G
      • Henderson N
      • Matekel R
      • Ryder M
      • Barber M
      • Allison S
      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee.
      • Green T
      • Refshauge K
      • Crosbie J
      • Adams R
      A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains.
      • Altman D
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      • Moher D
      • et al.
      The revised CONSORT statement for reporting randomized trials: explanation and elaboration.
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      Determining the sample size in a clinical trial.
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      Design and analysis of randomized clinical trials requiring prolonged observation of each patient.
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      Attitudes in clinical trials.
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      • et al.
      A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer.
      Intention to treat analysis can be a useful tool in interpreting study data. For example, when data from subjects who drop out of a study secondary to adverse effects are excluded, this certainly constitutes a potential bias in interpreting findings that would benefit from the addition of ITA. However, the retrospective requirement of ITA levied on all previous studies can discount evidence that should be considered on some level of the hierarchical ladder.
      • Haneline M
      • Altman D
      • Schulz K
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      • et al.
      The revised CONSORT statement for reporting randomized trials: explanation and elaboration.
      • Kirby A
      • Gebski V
      • Keech AC
      Determining the sample size in a clinical trial.
      Furthermore, in many studies with ITA, it is evident that many authors have serious objections to ITA being a sole arbiter of a valid or legitimate trial (SIGN rejects studies that do not use ITA).
      • Hollis S
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      Hollis and Campbell
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      • Campbell F
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      point out that 52% of medical trials fail or do a poor or an inadequate job with ITA. In a recent systematic review of 249 trials, Gravel et al
      • Gravel J
      • Opatrny L
      • Shapiro S
      The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?.
      pointed out that randomization was used only 77% of the time and ITA only 23% of the time, with ITA in general done poorly or incorrectly, or unclearly explained. Porta et al
      • Porta N
      • Bonet C
      • Cobo E
      Discordance between reported intention-to-treat and per protocol analyses.
      caution that ITA or PP analysis is flawed to such an extent that it is inappropriate to base conclusions of a controlled trial on single report of either ITA or the PP approach alone. Baron et al
      • Baron G
      • Boutron I
      • Giraudeau B
      • Ravaud P
      Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases.
      found that, out of 54 trials, full ITA analysis was done correctly in these studies only 7.4% of the time. For this reason, like randomization, it is important to use a ranking methodology that balances rigor with reason to yield the best evidence possible from the literature. Therefore, in this review, the absence of ITA results in a lower study rating. Furthermore, if essentially all subjects that began the trial complete the trial, ITA was rated as adequate.
      • Haneline M
      • Hollis S
      • Campbell F
      What is meant by intention to treat analysis? Survey of published randomised controlled trials.
      • Gravel J
      • Opatrny L
      • Shapiro S
      The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?.
      • Porta N
      • Bonet C
      • Cobo E
      Discordance between reported intention-to-treat and per protocol analyses.
      • Baron G
      • Boutron I
      • Giraudeau B
      • Ravaud P
      Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases.
      The initial step of using the modified Liddle et al SIGN to rank study methodology was followed by a synthesis and considered judgment whereby the authors scored the evidence with grades of “A, B, C, and I” as outlined in the Handbook for the Preparation of Explicit Evidence-Based Clinical Practice Guidelines

      Handbook for the preparation of explicit evidence-based clinical practice guidelines; New Zealand Guidelines Group.

      Greer N, Mosser G, Logan A, Halaas G. A practical approach to evidence grading, Jt Comm J Qual Improv 2001;26:700-712, 2000.

      (Fig 2). The “considered judgment on quality of evidence” was applied to all reviewed materials, including case series and studies from the previous review, and assessed per the grading recommendations as listed in Figure 2.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.

      Handbook for the preparation of explicit evidence-based clinical practice guidelines; New Zealand Guidelines Group.

      Greer N, Mosser G, Logan A, Halaas G. A practical approach to evidence grading, Jt Comm J Qual Improv 2001;26:700-712, 2000.

      Fig 2Summary of grading of strength of evidence.

      Handbook for the preparation of explicit evidence-based clinical practice guidelines; New Zealand Guidelines Group.

      Greer N, Mosser G, Logan A, Halaas G. A practical approach to evidence grading, Jt Comm J Qual Improv 2001;26:700-712, 2000.

      Grade A: good evidence from relevant studies
       • Studies with appropriate designs and sufficient strength to answer the questions.
       • Results are both clinically important and consistent with minor exceptions at most.
       • Results are free of significant doubts about generalizability, bias, and design flaws.
       • Negative studies have sufficiently large sample sizes to have adequate statistical power.
      Grade B: fair evidence from relevant studies.
       • Studies of appropriate designs of sufficient strength, but inconsistencies or minor doubts about generalizability, bias, and design flaws, or adequacy of sample size.
       • Evidence solely from weaker designs, but confirmed in separate studies.
      Grade C: limited evidence from studies/reviews.
       • Studies with substantial uncertainty due to design flaws or adequacy of sample size.
       • Limited number of studies; weak design for answering the question addressed.
      Grade I: no recommendation can be made because of insufficient or nonrelevant evidence.
       • No evidence that directly pertains to the addressed question because studies either have not been performed or published, or are nonrelevant.

      Results

      Of 389 citations identified, 39 were determined to be relevant and supplementary to the clinical or controlled trials previously found by Hoskins et al. Of the 39 studies, 8 pertained to conditions effecting the knee; 1, the hip; 7, the ankle; and 2, the foot. These studies were assessed. The case series and studies previously incorporated in 2006 have not been cited in this investigation; therefore, readers are referred to that review. However, 13 case series and studies excluded and/or not previously reported in a single source are included: 3 regarding the hip, 2 regarding the knee, 2 regarding the ankle, and 6 regarding the foot.

      Evidence

      There is a level of C or limited evidence for manipulative therapy combined with multimodal or exercise therapy of the hip for hip osteoarthritis.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • Brantingham J
      • Williams A
      • Parkin-Smith G
      • Weston P
      • Wood T
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • MacDonald C
      • Whitman J
      • Cleland J
      • Smith M
      • Hoeksma H
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      • Pollard H
      • Hoskins W
      • Schmerl M
      The use of hip manipulation in the management of acetabular labrum injury.
      • Whipple T
      • Plafcan D
      • Sebastianelli W
      Manipulative treatment of hip pain in a ballet student: a case study.
      There is a level of B or fair evidence for manipulative therapy of the knee and/or full kinetic chain combined with multimodal or exercise therapy for knee osteoarthritis.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Bennell KL
      • Hinman RS
      • Metcalf BR
      • et al.
      Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial.
      • Moss P
      • Sluka K
      • Wright A
      The initial effects of knee joint mobilization on osteoarthritic hyperalgesia.
      • Deyle G
      • Henderson N
      • Matekel R
      • Ryder M
      • Barber M
      • Allison S
      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee.
      • Deyle GD
      • Allison SC
      • Matekel RL
      • et al.
      Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program.
      • Tucker M
      • Brantingham J
      • Myburg C
      The relative effectiveness of a non-steroidal anti-inflammatory medication (meloxicam) versus manipulation in the treatment of osteoarthritis of the knee.
      • Cliborne AV
      • Wainner RS
      • Rhon DI
      • et al.
      Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization.
      • Currier LL
      • Froehlich PJ
      • Carow SD
      • et al.
      Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization.
      There is a level of B or fair evidence for manipulative therapy of the knee and/or full kinetic chain combined with multimodal or exercise therapy for patellofemoral pain syndrome.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Crossley K
      • Bennell K
      • Green S
      • Cowan S
      • McConnell J
      Physical therapy for patellofemoral pain. A randomized, double-blinded, placebo-controlled trial.
      • Hillermann B
      • Gomes A
      • Korporaal C
      • Jackson D
      A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength.
      • Drover JM
      • Forand DR
      • Herzog W
      Influence of active release technique on quadriceps inhibition and strength: a pilot study.
      • Suter E
      • McMorland G
      • Herzog W
      • Bray R
      Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain.
      • Rowlands B
      • Brantingham J
      The efficacy of patella mobilisation in patients suffering from patellofemoral pain syndrome.
      • Stakes N
      • Myburgh C
      • Brantingham J
      • Moyer R
      • Jensen M
      • Globe G
      A prospective randomized clinical trial to determine efficacy of combined spinal manipulation and patella mobilization compared to patella mobilization alone in the conservative management of patellofemoral pain syndrome.
      • Taylor K
      • Brantingham J
      An investigation into the effect of exercise combined with patella mobilisation/manipulation in the treatment of patellofemoral pain syndrome.
      There is a level of B or fair evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for ankle inversion sprain.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Eisenhart AW
      • Gaeta TJ
      • Yens DP
      Osteopathic manipulative treatment in the emergency department for patients with acute ankle injuries.
      • Dananberg HJ
      Manipulation of the ankle as a method of treatment for ankle and foot pain.
      • Jennings J
      • Davies G
      Treatment of cuboid syndrome secondary to lateral ankle sprains: a case series.
      • Green T
      • Refshauge K
      • Crosbie J
      • Adams R
      A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains.
      • Pellow JE
      • Brantingham JW
      The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains.
      • Coetzer D
      • Brantingham J
      • Nook B
      The relative effectiveness of piroxicam compared to manipulation in the treatment of acute grades 1 and 2 inversion ankle sprains.
      • Collins N
      • Teys P
      • Vicenzino B
      The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains.
      • Vicenzino B
      • Branjerdporn M
      • Teys P
      • Jordan K
      Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain.
      • Lopez-Rodriguez S
      • Fernandez de-Las-Penas C
      • Alburquerque-Sendin F
      • Rodriguez-Blanco C
      • Palomeque-del-Cerro L
      Immediate effects of manipulation of the talocrural joint on stabilometry and baropodometry in patients with ankle sprain.
      • Köhne E
      • Jones A
      • Korporaal C
      • Price JL
      • Brantingham JW
      • Globe G
      A prospective, single-blinded, randomized, controlled clinical trial of the effects of manipulation on proprioception and ankle dorsiflexion in chronic recurrent ankle sprain.
      • Dananberg HJ
      • Shearstone J
      • Guillano M
      Manipulation method for the treatment of ankle equinus.
      There is a level of C or limited evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for plantar fasciitis.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Wyatt LH
      Conservative chiropractic management of recalcitrant foot pain after fasciotomy: a retrospective case review.
      • Dananberg HJ
      • Shearstone J
      • Guillano M
      Manipulation method for the treatment of ankle equinus.
      • Dimou E
      • Brantingham J
      • Wood T
      A randomized, controlled trial (with blinded observer) of chiropractic manipulation and Achilles stretching vs orthotics for the treatment of plantar fasciitis.
      • Costa I
      • Dyson A
      The integration of acetic acid iontophoresis, orthotic therapy and physical rehabilitation for chronic plantar fasciitis: a case study.
      There is a level of C or limited evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for metatarsalgia.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Dananberg HJ
      • Shearstone J
      • Guillano M
      Manipulation method for the treatment of ankle equinus.
      • Petersen S
      • Brantingham J
      • Kretzmann H
      The efficacy of chiropractic adjustment in the treatment of primary metatarsalgia.
      • Govender N
      • Kretzmann H
      • Price J
      • Brantingham J
      • Globe G
      A single-blinded randomized placebo-controlled clinical trial of manipulation and mobilization in the treatment of Morton's neuroma.
      • Cashley D
      Manipulative therapy in the treatment of plantar digital neuritis (Morton's metatarsalgia).
      There is a level of C or limited evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for hallux limitus/rigidus.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Dananberg HJ
      Manipulation of the ankle as a method of treatment for ankle and foot pain.
      • Shamus J
      • Shamus E
      • Gugel RN
      • Brucker BS
      • Skaruppa C
      The effect of sesamoid mobilization, flexor hallucis strengthening, and gait training on reducing pain and restoring function in individuals with hallux limitus: a clinical trial.
      • Solan MC
      • Calder JD
      • Bendall SP
      Manipulation and injection for hallux rigidus. is it worthwhile?.
      • Brantingham J
      • Chang M
      • Gendreau D
      • Price J
      The effect of chiropractic adjusting, exercises and modalities on a 32-year old professional male golfer with hallux rigidus: a case report.
      There is a level of I or insufficient evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for hallux abducto valgus/bunion (Table 1).
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Brantingham J
      • Guiry S
      • Kretzmann H
      • Globe G
      • Kite V
      A pilot study of the efficacy of a conservative chiropractic protocol using graded mobilization, manipulation and ice in the treatment of symptomatic hallux abductovalgus bunions.
      Table 2, Table 3, Table 4, Table 5 summarize additional case series and studies and will be commented upon in the discussion section.
      Table 1Evidence table of manipulative therapy for lower extremity disorders
      AuthorStudy typeConditionParticipantsIntervention/controlFollow-upResults/outcomesGrade (below)Rating
      Hip
      Hoeksma et al
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      RCT^ (see § below)Hip osteoarthritisN = 109HVLA axial elongation hip manipulation with stretch vs exercise9 Txs/5 wkSignificant in favor of man therapy: primary, 2nd outcome measures (Likert scale): self report % improvement, and Harris hip score, VAS, ROMAdequate power, adequate blinding++
      Age, 60-85 y5 wkNo serious but minor ↑ adverse effects: 3 left man group, 2 exerciseInt to tx covered
      Mean age, 71.5 y17 wk
      29 wk FU
      Brantingham et al
      • Brantingham J
      • Williams A
      • Parkin-Smith G
      • Weston P
      • Wood T
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      CT¥ systematic assignment randomized 1st patient (then A, B, etc)Hip osteoarthritisN = 8HVLA axial elongation and other manipulations and mob of hip joint vs placebo6 Txs/3 wkSignificant effect size for man ther:Cohen d+
      Blind assessor/1 unblindedAverage age, 69.8y7 wkWOMAC, NRS vs placeboLarge effect size changes
      1 wk FUROM, Fabere unchanged in tx group
      2 Withdrew (N = 10)No adverse effects. 1 excluded, got PT. 1 sham left—pain to high
      Level of evidence for manipulative therapy for hip osteoarthritisAverage no. of txs: 7.5 over 3-5 wk1 High-quality trial, 1 low-quality trialGrade of evidence: C (man ther of the hip combined with multimodal or exercise therapy)
      Range, 6 to 9 (2 trials)
      Knee
      Deyle et al
      • Deyle G
      • Henderson N
      • Matekel R
      • Ryder M
      • Barber M
      • Allison S
      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee.
      RCTKnee osteoarthritisN = 83Manipulative therapy of knee and full kinetic chain SI-foot vs placebo = nontherapeutic ultrasound8 Txs/4 wkSignificant in favor of man therapy: at 4 and 8 wk. 8-wk WOMAC ↓ 55%, ↓ time 6-min walk. 1 year FU: WOMAC, walk significant. Arthroplasty 20% placebo, 5% in tx group.Adequate power++
      Mean age, 61 yKnee man: mob knee ↑ flex, ext, patellar mob (gradually up to 4++ or thrust)4 wkInt to tx covered
      8 wk
      1 y
      Deyle et al
      • Deyle GD
      • Allison SC
      • Matekel RL
      • et al.
      Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program.
      RCT^Knee osteoarthritisN = 134Man therapy of knee and full kinetic chain-SI to foot vs home exercise8 Txs/4 wkSignificant in favor of man therapy at 4, 8 wk with WOMAC 52% to exercise 26%. 1-year FU both significantly improved but man ↑ satisfaction, ↓ medsAdequate power++
      Mean age, 63 yKnee man: mob knee ↑ flex, ext, patellar mob (gradually up to 4++ or thrust)4 wkInt to tx well covered
      8 wk
      1 y
      Tucker et al
      • Tucker M
      • Brantingham J
      • Myburg C
      The relative effectiveness of a non-steroidal anti-inflammatory medication (meloxicam) versus manipulation in the treatment of osteoarthritis of the knee.
      RCT^Knee osteoarthritisN = 63CMT to the knee (HVLA) vs meloxicam 1×/d for 3 wk8 Txs/3 wkNo difference between txsNo patients left man ther group+
      Assessor not blindMean age, 59.3 yKnee man: long axis, A-P, P-A and patellar mobSignificant improvement both: NRS, VAS, PSFS. 3 left trial: NSAID adverse effects: nausea, diarrhea, allergic
      NSAID previously superior to placebo
      Moss et al
      • Moss P
      • Sluka K
      • Wright A
      The initial effects of knee joint mobilization on osteoarthritic hyperalgesia.
      RCTKnee osteoarthritisN = 38Supine A-P mobilization of tibia on femur within subjects repeated measures vs placebo (holding position) vs no contact1 TxSignificant ↓ in pain (=↑ in algometry) and ↑ speed in “up and go” (from chair)Adequate power+
      Allocated to 3 txsAdults ≥40Immediate postinterventionAdequate blinding
      Assessor, patients blindNo drop outsInt to tx adequate
      Bennell et al
      • Bennell KL
      • Hinman RS
      • Metcalf BR
      • et al.
      Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial.
      RCTKnee osteoarthritisN = 140PT program: knee taping, exercise, ST, thoracic spine mobilization vs placeboPT and placebo tx:No significant difference between groupsPower adequate+
      Double blindAge, 68.6 y8 TxsSignificant outcome for PT at 24 wk for VAS pain, global improvement (2 areas) out of 12 assessments (VAS pain and activity, WOMAC, KPS, SF-36, AQoL, quad strength, step test)In to tx good
      1×/wk for 4 wk then 1×/2 wk for 8 wk (8 txs)Poor design and internal validity: thoracic spine manipulation?
      13 dropped out PT (2 side effects others various reasons) 2 in placeboNonstandard
      No man therapy for knee/LE
      Level of evidence for manipulative therapy for knee osteoarthritisAverage no. of txs: 6.25 (range, 1-8 txs) over 4 wk (range, 1 tx to 8 wk; 2 with 1-y FU)2 High-quality trials, 3 mod-quality trialsGrade of evidence: B (man ther of the knee and/or full kinetic chain combined with multimodal or exercise therapy)
      Hillerman et al
      • Hillermann B
      • Gomes A
      • Korporaal C
      • Jackson D
      A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength.
      CTPFPS and quadriceps inhibition/weaknessN = 20SI manipulation vs knee axial elongation manipulation1 TxSignificant ↑ in intragroup knee extensor strength by Cybex after SI manipulationInt to tx adequate
      Allocation by presentation: PFPS, or PFPS + SI joint dysfnxAge, 18-40 y = PFPS with and without SIImmediate FU
      No loss of patients.
      Drover et al
      • Drover JM
      • Forand DR
      • Herzog W
      Influence of active release technique on quadriceps inhibition and strength: a pilot study.
      CTPFPS (AKPS)N = 9ART technique for knee vs testing normal contra lateral leg1 TxNo Significant change for all measures:Int to tx adequate
      Not randomizedMean age, 25.7 yImmediate FU1. Knee extension strength Biodex.
      Focus: effect on knee extensorsNo loss of patients2. mm inhibition: interpolated twitch torque technique
      Crossley et al
      • Crossley K
      • Bennell K
      • Green S
      • Cowan S
      • McConnell J
      Physical therapy for patellofemoral pain. A randomized, double-blinded, placebo-controlled trial.
      RCTPFPSN = 71PT (patellar mobilization tape, exercise, stretch, soft tissue) vs placebo (detuned ultrasound, tape, gel)6 Txs over 6 wkSignificantly in favor of PT group VAS, AKPS, step ups.Adequate power, adequate blinding++
      Double blindAge ≤40 y6 wkNo serious adverse effects. Side effects: soreness in 2 in PT and in PlaceboInt to tx reported
      3-mo FU PT group only
      Suter et al
      • Suter E
      • McMorland G
      • Herzog W
      • Bray R
      Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain.
      RCTPFPS (AKPS)N = 25HVLA sacroiliac manipulation only for PFPS vs control–no adjustment1 TxPre tx baselineInt to tx adequate++
      Double blindMean age, 34 yBoth measured for muscle inhibition , EMG and mm strength in quadricepsImmediate post tx follow-upSignificant decrease in MI by 7.5% using interpolated twitch torque techniqueSI relieves PFPS knee pain
      No loss of patientsNonsignificant ↑ in quad mm strength Cybex and EMG
      Rowlands and Brantingham
      • Rowlands B
      • Brantingham J
      The efficacy of patella mobilisation in patients suffering from patellofemoral pain syndrome.
      RCTPFPSN = 30Mob of patella vs placebo (detuned ultrasound)8 Txs/4 wkSignificant in favor of mob: ↓ pain with algometry and ↓ pain with McGill vs placeboMcGill % intergroup change very large mob vs placebo >80% power; (McGill correlates well 0-100 scales).+
      Single blindAve age, >18 y1-mo FUAlgometry <power
      Some dropouts; not noted2-mo study
      Stakes et al
      • Stakes N
      • Myburgh C
      • Brantingham J
      • Moyer R
      • Jensen M
      • Globe G
      A prospective randomized clinical trial to determine efficacy of combined spinal manipulation and patella mobilization compared to patella mobilization alone in the conservative management of patellofemoral pain syndrome.
      RCT^PFPSN = 60Patellar mob vs patellar mob and HVLA sacroiliac or L/S adjustment6 Txs over 4 wkNo difference between groups. Power not calculated; inter-group statistics must be viewed with caution.For both groups, magnitude of changes in NRS and PFJE scales %-appear statistically and clinically meaningful.+
      Single blind (see § below)Mean age, 30.5 y8 dropouts: 2 per group transport problems. No adverse effects. 2 per group lost to follow-up. Subjects replaced.Significant intragroup change for both groups: NRS, PFJE, SFMPQ, PSFS, and algometry
      Taylor and Brantingham
      • Taylor K
      • Brantingham J
      An investigation into the effect of exercise combined with patella mobilisation/manipulation in the treatment of patellofemoral pain syndrome.
      RCT (see § below)PFPSN = 12Patellar mob vs patellar mob + home exercise8 Txs over 4 wkDescriptive statistics suggest both txs helpful.Int to tx adequate+
      Blind assessorMean age, 30.17 y1-wk follow-up.Nonparametric intragroup significant for NRS, SFMPQ, ALG, and PSFS
      No unblinding5 wk
      No adverse effects
      All patients finished tx.
      Level of evidence for manipulative therapy for patellofemoral pain syndrome (aka anterior knee pain syndrome)Average no. txs: 4.43 txs (2 trials 6 txs, 2-8 txs; range 1-8 txs) over 4-8 wk (range 1 tx to 3-mo FU).2 High-quality, 2 moderate, 2 low-quality trialsGrade of evidence: B (man ther of the knee and/or full kinetic chain combined with multimodal or exercise therapy)
      Ankle
      Pellow and Brantingham
      • Pellow JE
      • Brantingham JW
      The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains.
      RCTAnkle sprainN = 30Manipulation ankle axial elongation (HVLA) vs detuned ultrasound (placebo)8 Txs (or til sx free)/4 wkSignificant for man ther for SFMPQ, functional improvement, at 8th tx, and for SFMPQ, functional, ROM 1-mo FU vs placeboPower adequate for intragroup+
      Single blindSubacute and chronicMean age, 24.9 y1-mo FUNo intention to treat
      Grade I and II2 mo
      >5 d
      Green et al
      • Green T
      • Refshauge K
      • Crosbie J
      • Adams R
      A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains.
      RCT^Ankle sprainN = 41RICE and tape and A-P talus mob vs control (RICE and tape)≤6 Txs/2 wkSignificant for man ther for ↑ ROM, ↓ pain, ↑ gait.Adequate blinding+
      Blind assessorAcute (72 h)Mean age, 25.5 yNo adverse effects.Faster recovery, activity with mobIntention to tx adequate
      No dropouts.
      Coetzer et al
      • Coetzer D
      • Brantingham J
      • Nook B
      The relative effectiveness of piroxicam compared to manipulation in the treatment of acute grades 1 and 2 inversion ankle sprains.
      RCT^ §Ankle sprainN = 30Both groups received (for ethical and methodological reasons) standard care = RICE.6 Txs/2 wk with 1-mo FUNo significant difference between groups except 6th tx ↑ ROM in favor man ther; and blind assessor detected ↓ restricted motion in joints in man ther group at FU.Power generally low+
      Retrospective 2nd author: appropriate randomization, adequately described in article. (see § Coetzer et al 2001)Acute ≤24 hMan ther: HVLA ankle manipulation-axial elongation and subtalar joint eversion vs NSAID (piroxicam)NSAIDSAll groups had significant intragroup improvement: ALG (↓ pain), goniometer (↑ ROM), NRS (↓ pain), athletic limitation ↑ function) and SFMPQ (↓ pain)Otherwise, essentially equal effects
      Blind assessor for motion palpation40 mg 2 d, 20 mg 5 d
      With 1-mo FU
      Eisenhart et al
      • Eisenhart AW
      • Gaeta TJ
      • Yens DP
      Osteopathic manipulative treatment in the emergency department for patients with acute ankle injuries.
      RCT^Ankle SprainN = 55Standard care (RICE + NSAIDS) vs standard care + osteopathic manipulative therapy (combination of HVLA, functional and ST1 Tx pre and post measures in ER. 1-wk FUSignificant for man ther post 1st tx for ↓ swelling, ↓ VAS.Int to tx performed+
      Single blindAcute grade I and II <24 hMean age, 30.5 y, >18Loss of patients n = 151-wk FU: significant for man ther ↑ ROM dorsiflexion
      Collins et al
      • Collins N
      • Teys P
      • Vicenzino B
      The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains.
      RCTAnkle sprainN = 16Mobilization with movement vs placebo (sham) or control (holding position only)1 Tx pre and postMan ther significant for ROM ↑ dorsiflexion2 left trial, 1 had increased pain.+
      Double blindSubacute grade IIMean age, 28.5 yAll txsNo change in PPT (algometry) or TPT (thermal pressure threshold)Int to tx not reported
      Dropouts discussed
      2 left trial, 1 ↑ pain.
      Vicenzino et al
      • Vicenzino B
      • Branjerdporn M
      • Teys P
      • Jordan K
      Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain.
      RCTAnkle sprainN = 161. MWM wt bearing post talar glide (PTG) and dorsiflexion ROM (DF)1 TxSignificant for man ther ↑ PTG° and DF° weight bearing and non-wb MWMInt to tx adequate++
      Random to 3 txsChronic recurrentMean age, 19.8 y2. Ditto but non–wt bearingImmediate post tx FULarge effect sizes PTG, Mod effect ↑ dorsiflex vs control
      Double blind<20 mm dorsiflexion in injured ankle inclusion3. Control–position heldNo loss of patients
      Lopez-Rodriguez et al
      • Lopez-Rodriguez S
      • Fernandez de-Las-Penas C
      • Alburquerque-Sendin F
      • Rodriguez-Blanco C
      • Palomeque-del-Cerro L
      Immediate effects of manipulation of the talocrural joint on stabilometry and baropodometry in patients with ankle sprain.
      RCTAnkle sprainN = 52Manipulation ankle axial elongation (HVLA) and supine HVLA A-P talar thrust vs placebo/control (holding position)1 TxSignificant for man ther ↑ in proprioception with stabilometry and baropodometry vs placeboInt to tx adequate+
      Single blindGrade II >5 dMean age, 22.5 yImmediate post tx or post placebo
      No loss of patients
      Kohne et al
      • Köhne E
      • Jones A
      • Korporaal C
      • Price JL
      • Brantingham JW
      • Globe G
      A prospective, single-blinded, randomized, controlled clinical trial of the effects of manipulation on proprioception and ankle dorsiflexion in chronic recurrent ankle sprain.
      RCT^ (see § below)Ankle sprainN = 30Manipulation ankle axial elongation (HVLA)6 Txs/4 wkSignificant for group 1 (6 txs) for ↑ proprioception and ↑ dorsiflexion ROM:+
      Baseline characteristics and statistics essentially equal (Kohne, E dissertation)Chronic recurrent grade I and IIMean age, 31.7 yGroup 1, 6 txs vs group 2 (control), 1 tx1-wk FU vs 1 txROM: strapped inclinometer ankle moved only by patient-↓ bias
      A “few” sensed ↑ “instability” in group 1 (Kohne dissertation)
      Level of evidence for manipulative therapy for ankle inversion sprainAverage txs: 3.75 txs (3 trials-6 txs; 1-8 txs; 4-1 tx; range 1- 8 txs) over 2-8 wk1 High-quality, 5 moderate, 2 low-quality trialsGrade of evidence: B (man ther for ankle sprain with multimodal or exercise therapy)
      Foot
       Plantar fasciitis
      Dimou et al
      • Dimou E
      • Brantingham J
      • Wood T
      A randomized, controlled trial (with blinded observer) of chiropractic manipulation and Achilles stretching vs orthotics for the treatment of plantar fasciitis.
      RCT^Plantar fasciitisN = 20Foot and ankle adjusting + stretching vs orthotics8 Txs/5 wkSignificant ↓ pain between groups in NRS at 4 wk in favor of man ther and stretchingInt to treat adequate+
      Randomization (see § below) and blind assessorChronic >7 wkMean age, 42.4 y1-mo follow-upSignificant (intragroup) for both txs (but not different) at 9 wk for ↓ 1st step pain, ↓ heel pain at rest and algometryLow power
      2 moNo adverse effects
      All patients
      completed treatment
      Level of evidence for manipulative therapy for plantar fasciitisAverage txs: 8 txs over 5 wk1 Moderate-quality trialGrade of evidence: C (man ther for plantar fasciitis with stretch/and or multimodal/exercise therapy)
       Metatarsalgia
      Petersen et al
      • Petersen S
      • Brantingham J
      • Kretzmann H
      The efficacy of chiropractic adjustment in the treatment of primary metatarsalgia.
      CT¥Metatarsalgia (common or mechanical)N = 40Man ther of foot and ankle (mob, HVLA: especially intermetatarsal glide, 1st MTPJ, etc) vs placebo (detuned ultrasound)8 Txs/4 wkSignificant in favor for man ther vs placebo for: SFMPQ, NRS, FFI and ALG._
      Systematic assignment (1st patient randomized)Mean age, 49.5 y4 dropouts, not clear which groups; none from adverse effects (family, business problems, etc).Note: placebo patients started with higher level of pain.
      Govender et al
      • Govender N
      • Kretzmann H
      • Price J
      • Brantingham J
      • Globe G
      A single-blinded randomized placebo-controlled clinical trial of manipulation and mobilization in the treatment of Morton's neuroma.
      RCTMorton neuroma (aka Morton metatarsalgia)N = 40Adjustive therapy (mob and HVLA) for foot and ankle vs placebo (detuned ultrasound)6 Txs over 3 wkSignificantly in favor for man ther: NRS and algometry vs placeboPower adequate+
      Single blind (see § below)Mean age, 51 yAll 20 finished trial. No dropouts.Int to tx adequate
      Adverse effects not reported.
      Level of evidence for manipulative therapy for metatarsalgiaAverage txs: 7.5 txs over 3-4 wks. 1 trial, 8 txs; 1, 6 txs.1 Moderate-quality trialGrade of evidence: C (man ther for metatarsalgia with/and without multimodal therapy)
      1 Poor-quality trial
       Hallux limitus/rigidus
      Shamus et al
      • Shamus J
      • Shamus E
      • Gugel RN
      • Brucker BS
      • Skaruppa C
      The effect of sesamoid mobilization, flexor hallucis strengthening, and gait training on reducing pain and restoring function in individuals with hallux limitus: a clinical trial.
      RCT^Hallux limitusN = 20Man ther of hallux and or/hallux and sesamoids + different physical therapy protocols:12 Txs/4 wkSignificant in favor of experimental tx for: ↑ ROM, ↑ strength, ↓ VAS, faster return of ROM and functionSingle blind (blind patients)+
      Mean age, 32.8 yComparative tx: modalities, hallux mob, exercise) vs experimental tx (same) + sesamoid mob, hallux flex strengthening, and gait retrainingNo dropoutsInt to Tx adequate
      2 Patients discharged at 10 visits (with relief)
      Level of evidence for manipulative therapy for hallux limitus/rigidus12 Tx/4 wk1 Moderate-quality trialGrade of evidence: C (man ther for hallux limitus/rigidus with multimodal therapy)
      Hallux abducto valgus (HAV or bunion)
      Brantingham et al
      • Brantingham J
      • Guiry S
      • Kretzmann H
      • Globe G
      • Kite V
      A pilot study of the efficacy of a conservative chiropractic protocol using graded mobilization, manipulation and ice in the treatment of symptomatic hallux abductovalgus bunions.
      RCTHAV (painful HAV)N = 60Man ther of hallux, foot and ankle (with a progressive protocol of mobilization to HVLA manipulation of the hallux) vs placebo (PT modality: nontherapeutic action potential therapy)6 Txs/3 wkSignificant in favor for man therapy for ↓ NRS, ↓ pain, disability, ↑ function with HAL and FFI vs placebo+
      Single blindAve age, 50.1 y1-wk follow-up
      7 wk total
      Dropouts not reported/unclear
      No reported adverse effects.
      Level of evidence for manipulative therapy for hallux abducto valgus/bunion6 Txs/3 wk1 Moderate-quality trial (no other known trials, case series, or case studies)Grade of evidence: I (man ther for hallux abducto valgus)
      The SIGN checklist rating (++, +, −) and a summary of grading strength of evidence (A, B, C, and I) are in Fig 1, Fig 2. RCT, Randomized controlled trial (treatment vs placebo); RCT^, randomized clinical trial (treatment vs another treatment; usually comparative treatment demonstrated superior to placebo or standard care); CT¥, controlled or clinical trial with systematic assignment (pseudorandomization) or nonrandomization, but with inclusion, exclusion, controlled, independent, and dependent variables vs placebo and/or comparative treatment.
      Table 2A summary of research on the hip: case series
      • Scottish Intercollegiate Guidelines Network
      A guideline developers' handbook.
      • Harbour R
      • Miller J
      A new system for grading recommendations in evidence based guidelines.
      • Liddle J
      • Williamson M
      • Irwig L
      Method for evaluating research and guideline evidence (MERGE).
      AuthorDiagnosisTreatment/managementReported outcome
      MacDonald et al
      • MacDonald C
      • Whitman J
      • Cleland J
      • Smith M
      • Hoeksma H
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      HOAMan ther of hip (grade IV and V) + exercise for (HOA) 5 treatments (over 2-5 wk)HHS for disability. 6 Patients: median improvement ↑ 25 points (clm change = ↑ 4 points).
      N = 7 Median age, 62 y1. HVLA axial elongation1 Patient (no HHS scale) but instead Global Rating of Change Scale: “ a great deal better”
      2. Various hip manipulation and mobilization techniques from multiple sources/textbooks7 Patients mean NPRS (↓ 5 points on 0-10 scale; clm 1.5-2 points)
      3. Hip, knee, and trunk exercises for hip OAGoniometry: global ↑ ROM 82°
      Conclusion: all ↓ pain, ↑ ROM
      Case series were assessed using the checklist for case series. HOA, Hip osteoarthritis; HHS, Harris hip scale; clm, clinically meaningful.
      Table 3A summary of research on the knee: case series
      AuthorDiagnosisTreatment/managementReported outcome
      Cliborne et al
      • Cliborne AV
      • Wainner RS
      • Rhon DI
      • et al.
      Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization.
      KOA N = 22 with KOA (mean age, 61 y) N = 17 normal and asymptomatic (age, 64 y)Man ther of hip (grade III and IV Maitland techniques) 1 Treatment–immediate post test 1 Group intragroup pre-post testNPRS ↓ and all clinical tests less painful (except hip flexion) in mobilization group posttest P< .05
      Does hip mobilization ↓ pain and ↑ ROM in KOA? What hip tests, etc + in both groups (Faber, hip ROM, Scour test, etc)?All clinical tests more + in KOA patients compared with normal asymptomatic, and less painful in symptomatic post test, except Faber)
      Currier et al
      • Currier LL
      • Froehlich PJ
      • Carow SD
      • et al.
      Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization.
      KOA N = 60 (51-79 y)Man the of hip (Maitland grade IV) + exerciseGlobal Rating of Change Scale ↑ 3.27 points (clinically meaningful)
      CPR: study to determine which KOA variables (patients) respond to hip mob and the validity of tests to predict outcome.4 TreatmentsNPRS, WOMAC, PSFS post test intragroup changes all statistically and clinically meaningful P < .05
      5 variables: 1. Hip/groin pain or parathesia 2. Anterior thigh pain 3. Knee flexion <122° 4. Hip internal rotation <17° 5. Pain with hip distractionImmediate and 48 h post test. 1 Group intragroup pre-post testCPR in symptomatic KOAIf + 2 CPRs 97% at 48-h follow-up (LR 5.1)If + 1 CPR 68% at 48 h
      Conclusion: CPR may improve examination and treatment of KOA
      For case series, the co-chairs of the CCGPP Scientific Commission developed a checklist modified from other instruments. KOA, Knee osteoarthritis; CPR, clinical prediction rule.
      Table 4A summary of research on the ankle and foot: case series
      AuthorDiagnosisTreatment/managementReported outcome
      Dananberg et al
      • Dananberg HJ
      • Shearstone J
      • Guillano M
      Manipulation method for the treatment of ankle equinus.
      AEMan ther + exercise (1 treatment manipulation and mobilization)Gravity goniometer strapped on and used only by patient (to ↓ bias): active ROM, patient pulling strap under foot, etc.
      N = 221 Group immediate pre-post testMean ↑ ankle dorsiflexion ROM 4.9° (left), 5.5° (right) t tests at 99% confidence level P < .001
      (= Abnormal loss of ankle dorsiflexion ROM ↓ less than 10° from neutral)1. P-A HVLA manipulation to proximal fibular headReports soreness in some ≤2 d but none later
      2nd diagnosis along with AE:2. Traction (mob) ankle/mortice: axial elongation with HVLA A-P talar thrustStates better than stretch alone
      a. Plantar fasciitis3. Then active dorsi/plantarflexion ROM movement of ankle by patient
      b. Acute chronic ankle sprain strain
      c. Achilles tendonitis
      d. Neuroma
      e. Metatarsalgia
      Dananberg
      • Dananberg HJ
      Manipulation of the ankle as a method of treatment for ankle and foot pain.
      AEMan ther + various treatments per condition: RICE, taping, exercise (inversion sprain), casting (Kohler) orthotics (hallux limitus)3-wk follow-up for all
      N = 31. Same as 2000 study plus:Descriptive outcomes.
      With:2. Manipulation of the 1st metatarsocuneiform joint for 1st MTPJ for ↓ big toe pain.Ankle sprain (and big toe pain)
      1. Inversion sprain–chronic (and had big toe pain too)1 Treatment resolved condition. ↑ ROM
      2. Kohler (osteochodrosis of the navicular with pain)Kohler disease—a few treatments quickly resolved navicular pain. Antalgia resolved.
      3. Hallux limitus (1st MTPJ stiffness and pain)Hallux limitus. A few treatments ↓ pain ↑ ROM of big toe.
      All patients had AE + additional diagnosis
      Jennings and Davies
      • Jennings J
      • Davies G
      Treatment of cuboid syndrome secondary to lateral ankle sprains: a case series.
      Cuboid syndrome: unresolved lateral ankle/cuboid painMan ther–HVLA “cuboid-whip” manipulationVAS pre and post (pre average VAS 2.85 and posttreatment VAS 0)
      N = 7Different patients received additional treatments: tape, stretch, orthotics, modalities.Improvements post tx: also in ↓ cuboid tenderness, MTJ mobility, antalgic gait and inability to do single hop
      Mean age, 21. 1 y 5 Had 1 manipulation
      a. 2nd to inversion 2 Had 2 manipulations
       Ankle sprain
      All college athletes and/or sports injuries
      Wyatt
      • Wyatt LH
      Conservative chiropractic management of recalcitrant foot pain after fasciotomy: a retrospective case review.
      Plantar fasciitis (recalcitrant lateral plantar pain, postfasciotomy–referred by podiatric surgeon for chiropractic after full postsurgical healing and 4-6 wk of NSAIDS, shoe padding, and rest)Man ther + multimodalVerbal Rating Scale (0-100)
      15 Patientsa. Manipulation and mobilization of the ankle and foot (including HVLA plantar to dorsal “snap or whip” manipulation.Most experienced quick relief
      Mean age, 46.4 yb. Exercise and change or ↓ activity11 Experienced significant or 90% relief on VRS
      None lost to FUc. 1 tx/wk for 2-8 visits over 2-8 wk3 Moderate relief (50-90%)
      1 No change
      9 Had minor adverse effects to man ther that resolved
      Solan et al
      • Solan MC
      • Calder JD
      • Bendall SP
      Manipulation and injection for hallux rigidus. is it worthwhile?.
      Hallux rigidus grades I-III (refers to radiographic findings)1 Man ther under anesthesia with steroid injection of the 1st MTPJ.Relief was defined as: period free of symptoms = pain and stiffness on walking/using foot, and in activities of daily living/function and or making a decision to have surgery.
      N = 371 Manipulation of hallux (manipulative technique not fully described)Grade I = 6 mo of relief
      Mean age, 52.3 y1-y follow-upGrade II = 3 mo of relief
      2 Lost to follow-upNo additional treatment: additional manipulation, exercise, stretch, medication, etc.Grade III = minimal to no relief.
      1-y follow-up 29 available12 Grade I, 4 went to surgery
      18 Grade II, 12 went to surgery
      5 Grade 3, all 3 went to surgery
      Conclusion: manipulation acceptable for grade I, limited for grade II, not indicated grade III
      For case series, the co-chairs of the CCGPP Scientific Commission developed a checklist modified from other instruments. AE, Ankle equinus.
      Table 5A summary of research on the hip/foot: case studies (descriptive)
      AuthorDiagnosisTreatment/managementReported outcome
      Whipple et al
      • Whipple T
      • Plafcan D
      • Sebastianelli W
      Manipulative treatment of hip pain in a ballet student: a case study.
      1. Acetabular anterosuperior labral tearMan ther 1 treatmentBegan VAS 7/10 with pain abducting when dancing.
      2. Instability (↑ ext. rot.)1. Cyriax technique (variation on technique for loose bodies):After treatment VAS 0/10
      3. Nonspecific hip paina. Axial elongation traction of the hip withWith abduction
      1 Patientb. 5 Mobilizations from 30°-75° abduction a. No pain on scour test
      1 Patient with symptoms for 1 mo. 14-y–old ballet dancer1 Visit b. ↑ External rotation persisted
      A. Overstretch.1-wk follow-up no symptoms
      B. Weight-bearing flexed/extended twist of hip dancing6-mo follow-up; 1 incidence of “giving way” otherwise no symptoms
      C. Painful click with abduction
      Pollard et al
      • Pollard H
      • Hoskins W
      • Schmerl M
      The use of hip manipulation in the management of acetabular labrum injury.
      1. Acetabular anterosuperior labral tear (arthroscopically confirmed)Man ther and mobilization (using multimodal and “MIMG” protocol–see article)Patient 1 ↓ hip pain 70%. Some pain with weight bearing and rotation of hip
      2 PatientsPatient 1: 10 visits/2 mo↓ CMLBP 80%-90%
      1. 45-y–old woman. Prolonged housecleaning 3 wk earlier (with 10 y of chronic mechanical LBP).Patient 2: 14 visits/21/2 moPatient 2 initially ↓ hip pain 30%, at 3- and 6-mo follow-up 0% (no) hip pain. Painless click
      2. 15-y–old swimmer with 3 wk of knee and groin paina. Hip long axis traction with HVLA variationsHip ROM still partially ↓
      b. Other hip manipulations and mobilizationsSurgical consult, but surgeon `recommends against at this time.
      c. PNF, exercise, SMT, knee manipulative therapy, and activity modifications10-14 Visits
      Costa and Dyson et al
      • Costa I
      • Dyson A
      The integration of acetic acid iontophoresis, orthotic therapy and physical rehabilitation for chronic plantar fasciitis: a case study.
      Plantar fasciitisMan ther + multimodal ther:Treatment began VAS 7/10 morning pain and 4/10 usual pain all day
      1 Patient. 15-y–old girl. Soccer injury. Knee and groin pain.a. Manipulation and mobilizationAfter 6 wk of treatment, resolution of symptoms 0/10
      Symptoms for 1 y even after treatment by GP and podiatrist–minimal help.b. Iontophoresis (acetic acid), orthotics, ice, tape, myofascial, exercise, stretch and activity changes, and therapy, etc.10 Visits
      3×/wk for 2 wk then 2×/wk for 2 wk or 10 total treatments
      Brantingham et al
      • Brantingham J
      • Chang M
      • Gendreau D
      • Price J
      The effect of chiropractic adjusting, exercises and modalities on a 32-year old professional male golfer with hallux rigidus: a case report.
      Hallux rigidus (grade I)Man ther + multimodal ther:NPRS 6/10
      1 Patient(All grades I-V)LEFI 22% (0-100, 100 worst), hallux dorsiflexion ROM 45°
      31-y–old male professional golfera. Hallux, ankle/foot, sesamoid mob and manipFinal visit
      Big toe pain and stiffness for 7 mod. Exercise therapy and stretchingNPRS 1-2/10
      e. UltrasoundLEFI 2%
      Quick relief after a few txsHallux dorsiflexion ROM 84°
      17 Visits/10 mo
      Cashley
      • Cashley D
      Manipulative therapy in the treatment of plantar digital neuritis (Morton's metatarsalgia).
      Plantar digital neuritis (Morton metatarsalgia)Man therDescriptive
      Aka Morton neuromaPatient 1: 4 txs plantarflexion HVLA manipulation at the MTPJsPatient 1 pain free by 4 wk.
       2 PatientsPatient 2: 3 txs over 6 wkFollow-up at 14 mo still pain and symptom free
      Patient 1. 25 y old. Symptoms 3 mo after soccer.Patient 2 pain free after 3 treatments.
      Patient 2. 63 y old. Symptoms 1 y. Steroid injections/orthotics with minimal relief.Follow-up at 8 mo still pain and symptom free
      LEFI, Lower extremity functional index.

      Discussion

      This literature review revealed new, recent, and previously noncited (secondary to limitations previously discussed) publications regarding manipulative treatment, for the most part with, but also without, adjunctive therapy (frequently exercise and/or rehabilitation and soft-tissue therapy, secondarily, in conjunction with modalities, NSAIDS, etc) for lower extremity conditions. There is an increase of limited and fair evidence for use of manipulative therapy in the treatment of a number of common lower extremity disorders since the Hoskins et al
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      2006 review. Within this new evidence, there exist several studies representing higher-level evidence with case studies/series of increasing quality continuing to proliferate. Also worth noting are the highly rated trials that have been included recently into systematic reviews for treatments of hip and knee osteoarthritis, patellofemoral pain syndrome, and inversion sprain. Interestingly, these competing systematic reviews that use a variety of methodologies reach opposite conclusions as to whether there is support or not for the same treatment. One surprising example of just such a finding is exercise for acute inversion sprain.
      • van der Wees P
      • Lenssen AF
      • Hendriks EJ
      • Stomp DJ
      • Dekker J
      • de Bie RA
      Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review.
      • Zhang W
      • Moskowitz R
      • Nuki G
      • et al.
      OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.
      • Dixit S
      • DiFiori J
      • Burton M
      • Mines B
      Management of patellofemoral pain syndrome.
      • Ivins D
      Acute ankle sprain: an update.
      • Kerkhoffs G
      • Handoll H
      • de Bie R
      • Rowe B
      • Struijs P
      Surgical versus conservative treatment for acute injuries of the lateral ligament complex of the ankle in adults.
      Overall, when reviewing the increasing quantity and quality of included trials, manipulative therapy for lower extremity disorders appears to be of value and is fundamentally safe. The trials and studies used numerous outcome measures, most with minimally general and some with a condition-specific validity and reliability, such as the following: primary patient report of improvement, algometry, visual analogue (VAS) and numerical rating pain (NPRS) scales, the short-form McGill pain questionnaire, Cybex isokinetic muscle testing, goniometry, anterior knee pain scale, Harris hip scale, Western Ontario and McMasters arthritis index (WOMAC), hallux metatarsophalangeal interphalangeal index, foot function Index, interpolated twitch and electromyography (EMG), and functional tests like “first step heel pain,” “step-ups,” “get up and go,” gait analysis, stabilometry, baropodometry, and orthopedic tests.
      The literature suggests sustained interest in the application of manipulative therapy for lower extremity conditions conveying the impression that the examination and usefulness of manipulative therapy procedures for lower extremity disorders have barely begun. There are studies for hip osteoarthritis, knee osteoarthritis, patellofemoral pain syndrome, ankle sprain, plantar fasciitis, metatarsalgia, Morton neuroma, hallux limitus, and hallux valgus; and case studies assessing hip manipulative therapy with exercise for hip osteoarthritis, knee manipulative therapy for hip osteoarthritis, the effect of hip manipulative therapy for knee osteoarthritis, ankle and/or foot manipulative therapy for treatment of ankle equinus, metatarsalgia, Achilles tendonitis, plantar fasciitis, Morton metatarsalgia, hallux manipulation and injection for treatment of hallux rigidus, and foot and ankle manipulative therapy for cuboid syndrome secondary to lateral ankle sprains; and other and various additional case studies demonstrating the momentum, growing interest, and publication in this area. The present studies of manipulative therapy for lower extremity disorders appear to parallel the results and overall beneficial outcomes per spinal research.
      • Bronfort G
      • Haas M
      • Evans R
      • Kawchuck G
      • Dagenais S
      Evidence-informed management of chronic low back pain with spinal manipulation and mobilization.
      • Carroll LJ
      • Cassidy JD
      • Peloso PM
      • et al.
      Methods for the best evidence synthesis on neck pain and its associated disorders: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.
      • Hurwitz EL
      • Carragee EJ
      • van der Velde G
      • et al.
      Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.
      It may be useful to investigate the most effective methods of manipulation/mobilization for every joint in the human body, based upon the combined level of evidence of the benefit of mobilization/manipulation for the axial and appendicular system as well as safety. One could tentatively posit that, in the presence of mechanical joint dysfunction, joint mobilization/manipulation appears to be universally indicated for lower limb joints as a therapeutic trial, in combination with other reasonable evidence-influenced conservative approaches, and for all common neuromusculoskeletal joint conditions, particularly where joint hypomobility is suspected as contributory. Common indications for the use of manipulative therapy, characterized by various definitions such as joint dysfunction, subluxation, or as a result of a clinical prediction rule, include (1) diagnosis of a painful neuromusculoskeletal joint disorder, (2) pain in or from palpation of bony joint surfaces, (3) pain in or from palpation of joint soft tissues, (4) decreased or altered range or quality of motion, and (5) pain on stressing and/or overstressing/provoking (in any or all planes) a joint.

      Peterson D, Bergmann T. Chiropractic technique: principles and procedures. 2nd ed. St. Louis, Missouri: Mosby; 2002. p. 97-169,184.

      • Tucker M
      • Brantingham J
      • Myburg C
      The relative effectiveness of a non-steroidal anti-inflammatory medication (meloxicam) versus manipulation in the treatment of osteoarthritis of the knee.
      • Cliborne AV
      • Wainner RS
      • Rhon DI
      • et al.
      Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization.
      • Collins N
      • Teys P
      • Vicenzino B
      The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains.
      • Gibbons P
      • Tehan P
      • Degenhardt B
      • Snider K
      • Snider E
      • Johnson J
      Interobserver reliability of osteopathic palpatory diagnostic tests of the lumbar spine: improvements from consensus training.
      Doctors of chiropractic are highly trained practitioners in HVLA thrusting techniques; but the profession has also used low-velocity, high- or low-amplitude mobilization techniques throughout the last century; and a myriad of mobilization techniques is well represented and used within the profession and these studies.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.

      Peterson D, Bergmann T. Chiropractic technique: principles and procedures. 2nd ed. St. Louis, Missouri: Mosby; 2002. p. 97-169,184.

      • Wardwell W
      • Stakes N
      • Myburgh C
      • Brantingham J
      • Moyer R
      • Jensen M
      • Globe G
      A prospective randomized clinical trial to determine efficacy of combined spinal manipulation and patella mobilization compared to patella mobilization alone in the conservative management of patellofemoral pain syndrome.
      • Taylor K
      • Brantingham J
      An investigation into the effect of exercise combined with patella mobilisation/manipulation in the treatment of patellofemoral pain syndrome.
      • Govender N
      • Kretzmann H
      • Price J
      • Brantingham J
      • Globe G
      A single-blinded randomized placebo-controlled clinical trial of manipulation and mobilization in the treatment of Morton's neuroma.
      Most manipulative therapy applied to extremity disorders is delivered as multimodal therapy, blending exercise, soft tissue treatment, modalities, or multiple extremity joint and/or combined spinal and extremity joint manipulative therapy, and is usually condition and patient specific.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • Deyle G
      • Henderson N
      • Matekel R
      • Ryder M
      • Barber M
      • Allison S
      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee.
      • Cliborne AV
      • Wainner RS
      • Rhon DI
      • et al.
      Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization.
      • Currier LL
      • Froehlich PJ
      • Carow SD
      • et al.
      Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization.
      • Stakes N
      • Myburgh C
      • Brantingham J
      • Moyer R
      • Jensen M
      • Globe G
      A prospective randomized clinical trial to determine efficacy of combined spinal manipulation and patella mobilization compared to patella mobilization alone in the conservative management of patellofemoral pain syndrome.
      • Taylor K
      • Brantingham J
      An investigation into the effect of exercise combined with patella mobilisation/manipulation in the treatment of patellofemoral pain syndrome.
      It appears that manipulative therapy with stretch is superior to either therapy alone in increasing range of motion (ROM), a possible solution to a previous conundrum of reductionistic interventional study.
      • Hoeksma HL
      • Dekker J
      • Ronday HK
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      • Brantingham J
      • Williams A
      • Parkin-Smith G
      • Weston P
      • Wood T
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • Deyle GD
      • Allison SC
      • Matekel RL
      • et al.
      Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program.
      • Tucker M
      • Brantingham J
      • Myburg C
      The relative effectiveness of a non-steroidal anti-inflammatory medication (meloxicam) versus manipulation in the treatment of osteoarthritis of the knee.
      Further research should address issues of safety, clinical predictors of efficacy and effectiveness, clarification of scope, and other similar issues.

      Limitations

      One limitation of this review is that some studies may have potentially been missed or were omitted for a priori reasons. For example, a study would have been missed if it did not contain the included search terms or key words or was simply not contained within the applicable/normative databases. Studies without a diagnosis (eg, measuring ROM), RCTs using immediate rehabilitative postsurgical manipulative therapy of an extremity, conference proceedings, red-flag conditions, or conditions that required referral were excluded.
      • Hoskins W
      • McHardy A
      • Pollard H
      • Windsham R
      • Onley R
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Fryer GA
      • Mudge JM
      • McLaughlin PA
      The effect of talocrural joint manipulation on range of motion at the ankle.
      • Nield S
      • Davis K
      • Latimer J
      • Maher C
      • Adams R
      The effect of manipulation on the range of movement at the ankle joint.
      • Pollard H
      • Ward G
      The effect of upper cervical or sacroiliac manipulation on hip flexion range of motion.
      • Licciardone JC
      • Stoll ST
      • Cardarelli KM
      • Gamber RG
      • Swift Jr, JN
      • Winn WB
      A randomized controlled trial of osteopathic manipulative treatment following knee or hip arthroplasty.
      Unfortunately, this means that interesting and informative studies such as an RCT of osteopathic manipulative treatment immediately after knee and/or hip arthroplasty, a study on manipulative management of foot pain due to an os peroneum and accessory navicular bone, or use of spinal manipulative therapy for a hamstring injury (without clear peripheral injury and diagnosis) and chiropractic management of injuries sustained during Brazilian capoeira (art that fuses dance, sport, and martial arts) were not included.
      • Wyatt LH
      Conservative chiropractic management of recalcitrant foot pain after fasciotomy: a retrospective case review.
      • Licciardone JC
      • Stoll ST
      • Cardarelli KM
      • Gamber RG
      • Swift Jr, JN
      • Winn WB
      A randomized controlled trial of osteopathic manipulative treatment following knee or hip arthroplasty.
      • Requejo S
      • Kulig K
      • Thordarson D
      Management of foot pain associated with accessory bones of the foot: two clinical case reports.
      • Hoskins WT
      • Pollard HP
      Successful management of hamstring injuries in Australian Rules footballers: two case reports.
      • Wessely M
      • Scheel L
      Chiropractic management of injuries sustained during Brazilian capoeira (conference proceedings).
      Future reviewers may want to consider including immediate (or rehabilitative) postsurgical manipulative therapy management.

      Conclusion

      There is a growing number of peer-reviewed, published studies of manipulative therapy for lower extremity disorders. Larger, methodologically improved, and well-funded randomized controlled and clinical trials, as well as observational, clinical, and basic science research, case series, and studies, are both needed and merited. Interdisciplinary collaboration should be encouraged and supported as well. Finally, the basic overarching model of similarity of indications for and beneficial effect/responsiveness of patients to manipulative therapies for joint conditions throughout the human body merits further attention.

      Practical Applications

      • There is fair evidence for manipulative therapy of the knee and/or full kinetic chain, and of the ankle and/or foot, combined with multimodal or exercise therapy for knee osteoarthritis, patellofemoral pain syndrome, and ankle inversion sprain.
      • There is limited evidence for manipulative therapy combined with multimodal or exercise therapy for hip osteoarthritis.

      Acknowledgment

      There were no declared conflicts of interest. Authors, independent reviewers, and panelists participated without compensation from any source, company, or organization. Cleveland Chiropractic College made an in-kind contribution to this systematic review by allowing Drs Brantingham and Globe and Ms Hicks to devote a portion of their work time to this project.

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