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The Effectiveness of Multimodal Care for Soft Tissue Injuries of the Lower Extremity: A Systematic Review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration
Submit requests for reprints to: Deborah A. Sutton, BSc(OT), MEd, MSc, Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, 6100 Leslie S, Toronto, ON, Canada M2H 3J1.
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAdjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
Professor, Department of Orthopedic Surgery, Occupational and Industrial Orthopedic Center, NYU School of Medicine, New York, NYProfessor, Department of Environmental Medicine, Occupational and Industrial Orthopedic Center, NYU School of Medicine, New York, NY
Canada Research Chair in Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT), Oshawa, ON, CanadaAssociate Professor, Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, ON, CanadaDirector, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, Toronto, ON, Canada
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAdjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaInstructor, Division of Undergraduate Education, Canadian Memorial Chiropractic College, Toronto, ON, Canada
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAdjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAssociate Clinical Research Scientist, Graduate Education and Research Programs, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaInstructor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
Director, Graduate Education Program, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAssistant Clinical Professor, Graduate Education and Research, Canadian Memorial Chiropractic College, Toronto, ON, Canada
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaAdjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaInstructor, Division of Undergraduate Education, Canadian Memorial Chiropractic College, Toronto, ON, Canada
Adjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaClinical Research Manager, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaSenior Clinical Research Scientist, Graduate Education and Research Programs, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
Adjunct Professor, Division of Graduate Education and Research, Canadian Memorial Chiropractic College (CMCC), Toronto, ON, CanadaPostdoctoral Fellow, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
Research Associate, UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology (UOIT) and Canadian Memorial Chiropractic College (CMCC), Toronto, ON, Canada
The purpose of this systematic review was to evaluate the effectiveness of multimodal care for the management of soft tissue injuries of the lower extremity.
Methods
We systematically searched MEDLINE, EMBASE, PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials from 1990 to 2015. Random pairs of independent reviewers screened studies for relevance and critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria. We included studies with a low risk of bias in our best evidence synthesis.
Results
We screened 6794 articles. Six studies had a low risk of bias and addressed the following: plantar heel pain (n = 2), adductor-related groin pain (n = 1), and patellofemoral pain (n = 3). The evidence suggests that multimodal care for the management of persistent plantar heel pain may include mobilization and stretching exercise. An intensive, clinic-based, group exercise program (strengthening, stretching, balance, agility) is more effective than multimodal care for the management of adductor-related groin pain in male athletes. There is inconclusive evidence to support the use of multimodal care for the management of persistent patellofemoral pain. Our search did not identify any low risk of bias studies examining multimodal care for the management of other soft tissue injuries of the lower extremity.
Conclusion
A multimodal program of care for the management of persistent plantar heel pain may include mobilization and stretching exercise. Multimodal care for adductor-related groin pain is not recommended based on the current evidence. There is inconclusive evidence to support the use of multimodal care for the management of persistent patellofemoral pain.
In addition, lower extremity pain was reported in up to 14% of individuals presenting to an emergency department after a motor vehicle collision in the United States.
Little is known about the health care use for soft tissue injuries of the lower extremity. Patellofemoral pain syndrome (PFPS) is a common lower extremity condition presenting to physicians in general practice with an annual incidence of 19/1000 among young and adolescent patients
The 6-year trajectory of non-traumatic knee symptoms (including patellofemoral pain) in adolescents and young adults in general practice: a study of clinical predictors.
Plantar heel pain is a frequent lower extremity complaint, with a point prevalence of 20.9% (95% confidence interval [CI], 17.7-24.4) reported in a general population study in Australia.
Is multimodal care effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Is multimodal care effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Examining combinations of interventions, as provided in multimodal care, is reflective of current practice by health care providers and is important to offer insight into and guide clinical practice.
Trials of multimodal care have been combined with trials of specific interventions in previous systematic reviews examining the management of lower extremity soft tissue injuries.
However, effectiveness or ineffectiveness of an intervention embedded within a multimodal program of care cannot easily be extracted from the effect of other interventions. Therefore, this methodology may lead to biased conclusions about the effectiveness of individual interventions and multimodal care.
The objective of our systematic review was to determine the effectiveness of multimodal care compared with other interventions, placebo/sham interventions, or no intervention in improving self-rated recovery, functional recovery, clinical outcomes, and/or administrative outcomes in adults and/or children with soft tissue injuries of the lower extremity.
Methods
Registration
This review protocol was registered with the International Prospective Register of Systematic Reviews on May 13, 2014 (CRD42014009778).
Eligibility Criteria
Population
We included studies of children and adults diagnosed as having soft tissue injuries of the lower extremity.
Are work disability prevention interventions effective for the management of neck pain or upper extremity disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Soft tissue injuries include but are not limited to grade I-II sprains/strains; tendonitis; tendinopathy; tendinosis; PFPS; iliotibial band syndrome; nonspecific hip, thigh, knee, ankle, or foot pain; and other soft tissue injuries as informed by available evidence. We defined sprains (Table 1) and strains (Table 2) according to the classification proposed by the American Academy of Orthopaedic Surgeons.
We excluded studies of lower extremity injuries due to major structural pathology (eg, grade III sprains or strains, cartilage-specific damage, fractures, dislocations, amputations, open wounds, tears of surrounding structures, osteoarthritis, inflammatory disorders, or neoplasms).
We defined multimodal care as a treatment approach that includes at least 2 distinct therapeutic modalities, provided by 1 or more health care disciplines.
Is multimodal care effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Noninvasive therapeutic modalities such as education, exercise, manual therapy, soft tissue therapy, passive modalities, acupuncture, and psychological interventions were included. We excluded studies where the effectiveness of 1 intervention could be isolated. For example, a study may examine the effectiveness of manipulation with stretching exercise compared with stretching exercise alone. In this case, the effectiveness of manipulation can be isolated from that of stretching exercise; therefore, this study would be excluded from this review.
Comparison Groups
We considered studies that compared multimodal care to other interventions, placebo/sham interventions, or no intervention.
Outcomes
Eligible studies included 1 of the following outcomes: self-rated recovery, functional recovery (eg, return to activities, work, or school), clinical outcomes (eg, pain, health-related quality of life, depression), administrative data (eg, time on benefits), or adverse events.
Study Characteristics
Eligible studies met the following criteria: (1) English language; (2) published between January 1990 and April 2015; (3) randomized control trials (RCT), cohort studies, or case-control studies; and (4) an inception cohort of at least 30 participants per treatment arm for RCTs, or 100 participants per treatment arm in cohort studies or case-control studies. Study exclusion criteria included the following: (1) letters, editorials, commentaries, unpublished manuscripts, dissertations, government reports, books and book chapters, conference proceedings, meeting abstracts, lectures and addresses, consensus development statements, or guideline statements; (2) pilot studies, cross-sectional studies, case reports, case series, qualitative studies, narrative reviews, systematic reviews, clinical practice guidelines, biomechanical studies, or laboratory studies; (3) surgical or invasive studies of the lower extremities; or (4) cadaveric or animal studies.
Information Sources
We developed our search strategy in consultation with a health sciences librarian (see Appendix 1 for the MEDLINE search strategy). A second librarian reviewed the search for completeness and accuracy using the Peer Review of Electronic Search Strategies Checklist.
We searched MEDLINE and EMBASE, considered to be the major biomedical databases, and PsycINFO for psychological literature, through Ovid Technologies Inc; CINAHL Plus with Full Text for the nursing and allied health literature through EBSCOhost; and the Cochrane Central Register of Controlled Trials for any studies not captured by the other databases through Ovid Technologies Inc. Our search strategies combined controlled vocabulary relevant to each database (eg, MeSH for MEDLINE) and text words relevant to our research question and the inclusion criteria (refer to Appendix 1 for the MEDLINE search strategy).
Study Selection
We used a 2-phase screening process to select eligible studies. In phase I, randomly paired reviewers independently screened titles and abstracts to determine study eligibility classifying studies as relevant, possibly relevant, or irrelevant. In phase II, the same reviewers independently reviewed manuscripts of possibly relevant studies to make a final determination of eligibility. Reviewers met to resolve disagreements and reach consensus in both phases. A third independent reviewer was involved if consensus could not be reached.
Assessment of Risk of Bias
Random pairs of trained independent reviewer pairs critically appraised the internal validity of eligible studies using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for RCTs, cohort studies, and case-control studies (Table 3).
The SIGN criteria assist with the evaluation of the impact of selection bias, information bias, and confounding on the results of a study. We did not use a quantitative score or a cutoff point to determine the internal validity of studies.
Rather, the SIGN criteria were used to assist reviewers in making an informed overall judgment on the internal validity of studies. This methodology has been previously described.
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.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Specifically, we critically appraised the following methodological aspects of RCTs: (1) clarity of the research question, (2) randomization method, (3) concealment of treatment allocation, (4) blinding of treatment and outcomes, (5) similarity of baseline characteristics between treatment arms, (6) cointervention contamination, (7) validity and reliability of outcome measures, (8) attrition, (9) analysis according to intention to treat principles, and (10) comparability of results across study sites (where applicable). Consensus between reviewers was reached through discussion. An independent third reviewer was used to resolve disagreements if consensus could not be reached. We contacted authors when additional information was needed to complete the critical appraisal. Studies with a low risk of bias were included in our evidence synthesis.
The lead author extracted data from studies with a low risk of bias into evidence tables (Table 4). A second reviewer independently checked the extracted data. We completed a qualitative synthesis of findings from the low risk of bias studies to develop evidence statements according to principles of best evidence synthesis.
Volunteers (18-40 y.o.) recruited through advertisements and referrals from GPs in Queensland, Australia, from May 2004 to May 2006
Multimodal care by a PT (6 visits/6 wk): patellar mobilization, patellar taping, progressive vasti muscle retraining exercises with EMG biofeedback, hamstring and anterior hip stretches, hip external rotator retraining, home exercise. (n = 45)
Foot orthosis: prefabricated foot orthosis (inbuilt arch support, 6° varus wedge); customizable with heel raise, wedge, or heat moulding; home exercise (foot arch-forming, weight-bearing calf stretches). (n = 46)
6 (immediately after intervention), 12 and 52 wk
Primary outcomes: global improvement (VAS, -100 = much worse, 0 = same, 100 = completely better); usual pain (VAS 0-100 mm); worst pain; AKPS (0-100); functional index questionnaire (0-16)
Foot orthoses vs flat inserts
Global improvement 6 wk: 19.8 (95% CI, 4.0-35.6)
No statistically significant or clinically important differences at 6, 12, or 52 wk for any of the other outcomes
Adverse events:
Rubbing and blistering, discomfort; pain in the toes, feet, ankles: foot orthoses 31/46 (67.4%); flat inserts 15/44 (34.1%); multimodal care plus foot orthosis 20/44 (45.5%)
Case definition: (1) anterior knee or retropatellar pain >6 wk duration; (2) provoked by ≥2 of the following: prolonged sitting or kneeling, squatting, running, hopping, or stair walking; (3) tenderness on palpation of the patella, or pain with step-down or double-leg squat; (4) worst pain ≥30/100 mm VAS over previous week. (n = 179)
Multimodal care plus foot orthosis by a PT (6 visits/6 wk) (n = 44)
Flat inserts: prefabricated flat inserts (3 mm thick); home exercise (balance training). (n = 44)
Adverse events
Skin irritation, blistering reaction to taping: multimodal care (18/45 (40.0%); multimodal care plus foot orthosis 16/46 (34.8%)
(34.1%); Multimodal care plus foot orthosis 20/44 (45.5%) Skin irritation, blistering reaction to taping: Multimodal Care (18/45 (40.0%); Multimodal Care plus Foot orthosis 16/46 (34.8%)
Case definition: clinically diagnosed patellofemoral pain (≥1 mo) with (1) anterior or retropatellar knee pain from ≥2 of the following: prolonged sitting, stair climbing, squatting, running, kneeling, hopping/jumping, or (2) pain on patellar facet palpation, step-down from 25-cm step, double-legged squat. (n = 71)
2.0 (95% CI, 1.0-3.5)
Usual pain (VAS 0-10 cm)
1.5 (95% CI, 0.5-2.5)
Secondary outcomes: health related quality of life (SF-36); activity during previous week; functional measurement (the number of step-ups, step-downs, or squats before onset or increase of pain)
Function (FIQ 0-16) 1.0 (95% CI, 0.0-3.0)
Pain (AKPS 0-100)
10 (95% CI, 5.0-14.0)
Perceived improvement (index group: placebo)
Moderate or marked improvement:
RR, 1.41 (95% CI, 1.07-1.84)
Marked improvement:
RR, 3.39 (95% CI, 1.69-6.80)
Secondary outcomes:
Statistically significant improvement in step-up, step-down, and squat
P < .05, data not provided.
favoring multimodal care. There were no clinical or statistical differences in remaining secondary outcomes.
Adverse Events
Minor skin irritation from tape. Three additional minor adverse reactions (not specified).
Patients (≤50 y.o.) referred to kinesiology laboratory
Leg press (LP) using an EN-Dynamic Track Machine. Patients unilaterally trained at 60% of 1-repetition maximum for 5 sets of 10 repetitions (3x/wk for 8 wk); hot pack applied to quadriceps prior to exercise; cold pack and stretching after exercise. (n = 30)
Health education material regarding patellofemoral pain. (n = 30)
8 wk (immediately after intervention)
Primary outcome:
Leg press—health education
Worst pain previous week (0-100 mm VAS); function (Lysholm scale, 0-100); VMO morphology: cross-sectional area
Case definition: PFPS with at least 2 of the following: (1) patellar crepitus, (2) Clarke sign, (3) patellar grind test, (4) tenderness upon palpation of the posterior surface of the patella or surrounding structures, or (5) pain after resisted knee extension. (n = 89)
Leg press + hip abduction (LPHA), same as leg press with addition of 50-N hip abduction force applied to the distal one third of the thigh (3x/wk for 8 wk) with 15 min of hot pack applied to quadriceps femoris prior to exercise (n = 29)
2.41 (95% CI, 1.62-3.20)
Function (0-100)
10.2 (95% CI, 6.51-13.89)
VMO cross-sectional area (cm2)
0.72 (95% CI, 0.18-1.26)
VMO volume (cm3)
1.01 (95% CI, 0.28-1.74)
Results for Leg Press + Hip Adduction are not reported due to ineligible (<30) sample size.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Patients (18-60 y.o.) recruited from outpatient orthopaedic PT clinic in the United States and New Zealand. Recruited from October 2006 to January 2008.
Multimodal care by a PT (6 visits/4 wk): clinic and home based manual therapy (mobilization, manipulation), stretching exercise, instruction to perform ADL that did not aggravate symptoms and avoid those that aggravated symptoms. (n = 30)
Multimodal care by a PT (6 visits/4 wk): ultrasound, iontophoresis with dexamethasone, stretching and strengthening exercise, ice, home exercise, instruction to perform ADL that did not aggravate symptoms and avoid those that aggravated symptoms. (n = 30)
1 (immediately after intervention) and 6 mo
Primary outcome: disability (LEFS 0-80)
Multimodal care (mobilization)—multimodal care (ultrasound)
Secondary outcomes: Foot and Ankle Ability Measure (FAAM), ADL subscale: (0-84, expressed as percentage); pain (NRS 0-10); global improvement (−7 to +7)
Difference in mean change:
LEFS (0-80)
1 mo: 13.5 (95% CI, 6.3-20.8)
6 mo: 9.9 (95% CI, 1.2-18.6)
FAAM ADL (0-100%)
1 mo: 13.3% (95% CI, 4.6-22.0)
Case definition: plantar heel pain and Lower Extremity Functional Scale (LEFS) score of ≤65. (n = 60)
6 mo: 13.6% (95% CI, 3.2-24.1)
NRS (0-10)
1 mo: 1.5 (95% CI, 0.4-2.5)
Global Improvement (−7 to +7) 1 mo: 1.7 (95% CI, 0.4-3.0)
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Patients (>18 y.o.) referred by an orthopedic surgeon to an outpatient physiotherapy clinic in Israel. Recruited from September 2006 to March 2009)
Multimodal care by a PT (1-2 visits/wk; total 8 treatments over 6 wk): 10 min of deep massage mobilization techniques directed to incompliant and painful areas of the posterior calf muscle group; stretching exercise (3 times/d): intermittent self-stretching of posterior calf muscles with 5 repetitions for each stretch in a standing position (20 s stretching followed by 10-s rest), verbal instruction and illustrated instruction sheet provided, and neural mobilization exercise SLR and ankle dorsiflexion using a long belt to stretch neural structures of calf muscles. (n = 36)
Multimodal care by a PT (1-2 visits/wk total 8 treatments over 6 wk): 3 min of continuous radiation ultrasound over painful area (frequency = 1 MHz, intensity = 1.0 W/cm2; and, same stretching exercise as for multimodal care with deep tissue massage. (n = 36)
Immediately after intervention (6 wk)
Primary outcome: functional status (CAT, 0-100)
Multimodal care (deep massage)—multimodal care (ultrasound)
Secondary outcome: first step pain (VAS, 0-10 cm)
Difference in mean change
Functional Status (0-100)
6 wk: 11 (95% CI, 0.7-16)
Case definition: plantar heel pain on initial weight bearing after a period of rest, lessening with continued activity. (n = 72)
Male athletes (18-50 y.o.) referred by physicians and PTs or recruited through advertising in Denmark. Recruited from January 1991 to November 1995.
Multimodal care by PT (2 × 90-min visits per week/8-12 wk): laser, transverse friction massage, stretching, TENS, home exercise. Advice to avoid athletic activity except pain-free cycling, jogging on flat surface allowed after 6 wk. (n = 34)
Exercise (group) by PT (3 × 90-min group sessions per week/8-12 wk): exercise, home exercise. Advice to avoid athletic activity except pain-free cycling, jogging on flat surface allowed after 6 wk. (n = 34)
4 mo after the end of treatment
Subjective global assessment of improvement (much better, better, not better, worse, and much worse)
Global assessment of improvement (index group: multimodal care)
Much Better or better:
RR, 0.93 (95% CI, 0.75-1.16)
Much better:
RR, 0.59 (95% CI, 0.36-0.97)
Case definition: groin pain ≥2 mo, pain on palpation of adductor tendons or insertion on pubic bone, groin pain during resisted adduction, and 2 of the following: characteristic history, painful palpation of synthesis joint, scinitgraphic activity (pubic bone), or radiographic signs of osteitis pubis. (n = 68)
ADL, activities of daily living; AKPS, Anterior Knee Pain Scale; CI, confidence interval; EMG, electromyography; FAAM, Foot and Ankle Ability Measure; FIQ, Functional Index Questionnaire; GPs, general practioners; LEFS, Lower Extremity Function Scale; NRS, Numeric Rating Scale; PFPS, patellofemoral pain syndrome; PT, physical therapist; RR, relative risk; SF-36, 36-item Short Form Health Survey; SLR, straight leg raise; TENS, transcutaneous electrical nerve stimulation; VAS: visual analog scale; VMO, vastus medialis oblique muscle; y.o., years old.
a Clinical or statistical significant differences only reported.
We stratified our synthesis according to disorder type and duration (ie, recent [≤3 months], persistent [>3 months]). We further stratified the multimodal programs of care according to their effectiveness, to facilitate determination of intervention components associated with superior outcomes: (1) superior (associated with a minimal clinically important difference [MCID] compared with its comparator)
, (2) equivalent (no clinically important differences between groups), and (3) inferior (associated with worse outcomes than its comparator). The following MCID thresholds were used: 2/10 cm on the visual analog scale (VAS) for worst pain,
The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network.
How well are you recovering? The association between a simple question about recovery and patient reports of pain intensity and pain disability in whiplash-associated disorders.
The percentage agreement for critical appraisal was calculated for all studies. Similarly, we computed the difference in mean change between groups and its 95% CI to quantify effect sizes. The computation of the 95% CI for the difference in mean change assumed that the preintervention and postintervention outcomes were highly correlated (r = 0.8).
Our search yielded 7729 articles. We removed 935 duplicates and screened 6794 articles (Fig 1). Of those, 9 studies were eligible for critical appraisal and 6 studies, all RCTs, had a low risk of bias, and were included in our synthesis. During critical appraisal of articles, we contacted the authors of 3 studies for further information and clarification
The interrater agreement for the screening of articles was κ = 0.67 (95% CI, 0.42-0.92). The percentage agreement for the critical appraisal of articles was 77.8% (7/9 studies).
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
These studies were clinically heterogeneous and could not be pooled in a meta-analysis.
The multimodal programs included several interventions (Table 5). Exercise (3/3 studies), education (2/3 studies), and taping (2/3 studies) were the most common interventions for the management of PFPS. Only physical therapists delivered the multimodal care interventions for the management of patellofemoral pain, plantar heel pain, and adductor-related groin pain.
Table 5Combinations of Interventions in Multimodal Care for Lower Extremity Soft Tissue Injuries Reported in Scientifically Admissible Randomized Controlled Trials, 1990-2014
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
All 6 RCTs with low risk of bias included the following: a clearly focused question, concealment of treatment allocation, blinding of treatment and outcomes, baseline similarity of groups, and used intention-to-treat analysis (Table 3).
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
However, in the 6 studies with low risk of bias, there were some limitations including the following: (1) the randomization method was inadequately described,
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Evidence from 1 RCT suggests that compared with education alone, an exercise-based multimodal care program by a physical therapist may benefit patients with persistent PFPS (Table 4).
randomized participants to (1) multimodal care that included hot pack application to the quadriceps femoris, followed by leg press exercise, then stretching and cold pack application; (2) multimodal care plus hip adduction strengthening; or (3) health education material regarding PFPS (format not specified). Multimodal care was provided in 3 visits/wk for 8 weeks. Results from the multimodal care plus hip adduction arm are not presented due to the small sample size (n < 30). Participants receiving multimodal care reported statistically significant but nonclinically important improvement in worst pain (VAS) in the previous week (2.41/100; 95% CI, 1.62-3.20). They also reported statistically significant improvement of unknown clinical importance in function (Lysholm Scale; 10.2/100; 95% CI, 6.51-13.89), vastus medialis oblique morphology cross-section size (0.72 cm2; 95% CI, 0.18-1.26), and vastus medialis oblique morphology volume (1.01 cm3; 95% CI, 0.28-1.74) immediately after intervention. Although statistically significant differences were observed in all outcome measures, there is uncertainty regarding the reporting of pain intensity. Specifically, the pain measurement scale (VAS 0-100 mm) described in the methodology and tables is incongruent (eg, the value is very small [mean, <5.0 preintervention], given that the primary complaint in PFPS would be anticipated to be pain). We contacted the authors for clarification, but no response was received. Therefore, the results of this study should be interpreted with caution.
Evidence from a second RCT suggests that compared with education, multimodal care by a physical therapist may benefit patients with persistent (>3 months) PFPS (Table 4). Crossley et al
randomized participants to the following: 1) multimodal care (education, patellar taping, exercise, massage, patella mobilization) or (2) education, placebo taping, and sham ultrasound; each protocol was provided in 6 visits for 6 weeks. Multimodal care participants reported statistically significant and clinically important improvement in worst pain (mean change difference, 2.0/10; 95% CI, 1.0-3.5), usual pain (mean change difference, 1.5/10; 95% CI, 0.5-2.5), and anterior knee pain (Anterior Knee Pain Scale; mean change difference, 10/100; 95% CI, 5.0-14.0) immediately after intervention. Multimodal care participants were more likely to report “marked improvement” in global improvement (relative risk [RR], 3.39; 95% CI, 1.69-6.80) and “moderate or marked improvement” (RR, 1.41; 95% CI, 1.07-1.84) than the comparison group immediately after intervention. Statistically significant improvement in secondary outcomes of step-up, step-down, and squats was also reported.
Lastly, evidence from 1 RCT suggests that multimodal physiotherapy, foot orthoses plus exercise, flat inserts plus exercise, and multimodal physiotherapy plus a foot orthosis offer similar outcomes for the management of persistent (>3 months) PFPS (Table 4). Collins et al
randomized participants to the following: (1) multimodal care (patellar mobilization, patellar taping, supervised and home exercise); (2) prefabricated foot orthoses customizable with heel raise, wedge, or heat molding, plus home exercise; (3) flat inserts plus home exercise; or (4) multimodal care plus foot orthoses, offered in 6 visits for 6 weeks. There was a statistically significant difference favoring foot orthoses plus exercise compared with flat inserts plus exercise immediately after intervention (mean change difference, 19.8/−100 to 100; 95% CI, 4.0-35.6). However, the MCID for global improvement is not known. There were no other statistically significant or clinically important differences reported for the remaining outcomes at any follow-up.
Persistent Plantar Heel Pain
Evidence from 1 RCT suggests that multimodal care that includes manual therapy is more effective than multimodal care that includes ultrasound provided in 6 visits for 4 weeks for the management of persistent plantar heel pain (Table 4). Cleland et al
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
randomized participants to the following: (1) multimodal care including manual therapy (mobilization, manipulation) and exercise or (2) multimodal care including ultrasound, iontophoresis with dexamethasone, ice, and exercise. Both groups were provided with instructions to continue to perform their daily activities and avoid activities that aggravated their symptoms. Participants receiving multimodal care with manual therapy and exercise reported statistically significant and clinically important improvement in disability as measured by the Lower Extremity Function Scale at each time point (1 month: mean change difference, 13.5/80 [95% CI, 6.3-20.8]; 6 months: mean change difference, 9.9/80 [95% CI, 1.2-18.6]) and the activities of daily living subscale of the FAAM (1 month: mean change difference, 13.3/100 [95% CI, 4.6-22.0]; 6 months: mean change difference, 13.6/100 [95% CI, 3.2-24.1]). Furthermore, there were statistically significant differences in pain at 1 month, and global improvement at 1 and 6 months favoring multimodal care with manual therapy and exercise. However, the improvement in pain was not clinically important, and the MCID of global improvement is not known.
Evidence from a second RCT suggests that multimodal care including deep massage and mobilization provided by a physical therapist offers greater short-term benefit to patients with persistent plantar heel pain compared with multimodal care which includes ultrasound (Table 4). In their RCT, Saban et al
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
randomized patients to the following: (1) deep massage, self-mobilization exercise, and self-stretch exercise, or (2) ultrasound and self-stretch exercise, with both protocols offered in 8 treatments for 6 weeks. There was a statistically significant and clinically important difference in function favoring multimodal care including deep massage, self-mobilization exercise, and self-stretch exercises immediately after intervention (mean change difference, 11/100; 95% CI, 0.7-16). There was no between-group difference for the secondary outcome of first step pain.
Persistent Adductor-Related Groin Pain
Evidence from 1 RCT conducted in a sample of male athletes suggests that exercise provided in a group setting by a physical therapist is more effective than individual multimodal care by a physical therapist for the management of adductor-related groin pain (Table 4). Holmich et al
randomized male athletes with a clinical diagnosis of adductor-related groin pain to the following: (1) multimodal care (laser, transverse friction massage, transcutaneous electrical nerve stimulation, stretching exercise), or (2) group exercise (strengthening, stretching, balance, agility). Multimodal care was offered in 2 visits per week, whereas the group exercise program was offered 3 times per week, for 8 to 12 weeks. Both groups were advised to avoid athletic activity, except pain-free cycling, and were permitted to jog on a flat surface after 6 weeks as long as groin pain was not provoked. Four months after the intervention, the incidence of global improvement was lower in the multimodal care group (“much better” RR, 0.59; 95% CI, 0.36-0.97) than in the exercise group.
Adverse Events
Three studies reported on adverse events, which were all transient in nature.
Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial.
reported minor skin irritations from the tape. Three other minor adverse events (not specified) which did not affect the interventions were also reported.
reported rubbing, blistering and pain associated with wearing the foot orthoses and flat inserts, and skin irritation among participants receiving patellar taping. Cleland et al
Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial.
reported that there were no adverse events during their study.
Discussion
Summary of Evidence
Our systematic review informs the management of lower extremity soft tissue injuries. For persistent plantar heel pain, a multimodal program of care may include mobilization and stretching exercise.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
A group exercise program offered more benefit than a multimodal program of care for the management of adductor-related groin pain in a population subset (male athletes 18-50 years old) undergoing an intensive return to play program; however, this may not be generalizable to the general population.
Previous systematic reviews dedicated exclusively to multimodal care were not found. However, studies that include multimodal care have been considered within the context of systematic reviews of single interventions. This is problematic because the effects of single interventions cannot be isolated in multimodal programs of care. There are differences in our results compared with those reported by previous systematic reviews. Our review concurs with that of Bolgla and Boling,
who reported that evidence was too inconsistent or limited to support combinations of conservative interventions (multimodal care) for the management of PFPS. However, our review did not agree with 2 systematic reviews which support the use of multimodal care for the management of PFPS. Brantingham et al
reported that there was evidence to support the inclusion of manual therapy in multimodal care or combined with exercises for the short- and long-term management of PFPS. Moreover, Collins et al reported that there was evidence that multimodal physiotherapy (taping, mobilization, exercise) was effective for the short-term management of PFPS. However, these authors acknowledge the limitations of including studies with varying levels of evidence including those with small sample sizes (n < 30), inadequate randomization methods, and lack of intention-to-treat analysis.
However, our review found that mobilization and stretching exercise was effective for the management of plantar heel pain, concurring with Brantingham et al,
who reported that there was evidence to support manual therapy in combination with multimodal or exercise therapy for the short-term management of plantar fasciitis. Furthermore, our review concurs with Almeida et al,
who report that the available evidence for conservative interventions for the treatment of exercise-related groin pain demonstrates short-term benefit of exercise but that the evidence is exclusively related to athletes.
Implications of the Research
The findings of our review will assist clinicians in making evidence-based decisions regarding the use of multimodal care for the management of soft tissue injuries of the lower extremity. Use of evidence-based interventions is important to minimize the impact of soft tissue injuries on daily function and the ability to work.
The current highest-quality evidence suggests that a multimodal program of care that includes mobilization (hip, knee, ankle, foot) and stretching exercises (calf) can benefit individuals with persistent plantar heel pain. The clinician should draw upon research to identify individual noninvasive treatment modalities for which there is high-quality evidence to develop a plan of care, for example, static plantar fascia stretching for plantar heel pain.
The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: a systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Clinicians should not use multimodal care to manage other soft tissue injuries of the lower extremity as there is currently no evidence to support its use.
Strengths and Limitations
Our review has strengths. First, we searched 5 databases and the search strategy was peer reviewed by a second librarian to minimize errors. Second, we used clear inclusion and exclusion criteria to identify relevant citations. Third, the critical appraisal process was standardized using the SIGN criteria. Finally, we minimized the risk of bias associated with using low-quality studies by using best-evidence synthesis to form our conclusions.
Our review also has limitations. First, we restricted our search to include articles in the English language, which may have excluded some relevant studies. However, limiting a search to English language was not found to bias results in other systematic reviews of clinical trials.
Second, our review included clinically heterogeneous multimodal programs of care. This level of clinical heterogeneity did not allow for the pooling of results through meta-analysis. Furthermore, we did not review qualitative studies exploring the lived experience of patients receiving multimodal care. We are unable to comment on how patients value and experience exposure to multimodal care. Although this is not a source of bias in our review, it is recommended that future reviews consider examining qualitative studies to gain insight into the patients’ perspective of multimodal care.
Recommendations for Future Research
Although clinicians often combine several modalities in a program of multimodal care, no current research examines this. Future research should address this important gap in the literature. Future studies should be of high methodological quality, that is, use appropriate randomization methods, adequate sample size, and use an intention to treat analysis.
It is clinically relevant to identify a program of care, including intensity and duration, to best manage soft tissue injuries of the lower extremity to facilitate positive outcomes. Furthermore, we need more studies of multimodal care for the management of other soft tissue injuries of the lower extremity not identified in our systematic review.
Conclusion
Our review clarifies the role of multimodal care (mobilization and exercise) for the management of plantar heel pain. Evidence is inconclusive regarding multimodal care for persistent patellofemoral pain. Although an intensive return to play program is more effective than multimodal care for the management of persistent adductor-related groin pain in male athletes, similar interventions should be studied in general population samples. We found no high-quality studies that inform the management of other soft tissue injuries of the lower extremity.
Funding Sources and Potential Conflicts of Interest
This study was funded by the Ontario Ministry of Finance and the Financial Services Commission of Ontario (RFP#.: OSS 00267175). The funding agency was not involved in the collection of data, data analysis, interpretation of data, or drafting of the manuscript. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Dr Pierre Côté, Canada Research Chair in Disability Prevention and Rehabilitation at the University of Ontario Institute of Technology. Pierre Côté has previously received funding from the Ontario Ministry of Finance; consulting for the Canadian Chiropractic Protective Association; speaking and/or teaching arrangements for the National Judicial Institute and Société des Médecins Experts du Quebec; and trips/travel from European Spine Society; is a member of board of directors of European Spine Society; and received grants from Aviva Canada and fellowship support from Canada Research Chair Program–Canadian Institutes of Health Research. No other conflicts of interest were reported for this study.
Contributorship Information
Concept development (provided idea for the research): M.N., P.C., H.Y., J.W., S.V., H.S., R.G.
Design (planned the methods to generate the results): M.N., P.C., J.W., S.V., D.S., H.S., M.S., R.G.
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): M.N., P.C., H.S.
Data collection/processing (responsible for experiments, patient management, organization, or reporting data): De.S., M.N., K.R., H.Y., J.W., P.S., S.V., D.S., H.S., C.C., R.G.
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): De.S., M.N., P.C., K.R., H.Y., H.S., M.S., L.C.
Writing (responsible for writing a substantive part of the manuscript): De.S., M.N., P.C.
Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): De.S., M.N., P.C., K.R., H.Y., J.W., P.S., S.V., D.S., H.S., M.S., C.C., R.G., L.C.
Practical Applications
•
There is inconclusive evidence to support the use of multimodal care for the management of persistent patellofemoral pain.
•
A multimodal program of care may include mobilization and stretching exercise for the management of persistent plantar heel pain.
•
Multimodal care for adductor-related groin pain is not recommended based upon the best available evidence.
Search run March 17, 2015 in Ovid MEDLINE(R) 1946 to March Week 2 2015; 477 results; Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations March 16, 2015; 39 results
Note: Search run from last day run (April 9, 2014): limit 103 to ed=20140409-20150317
SR_LowerExtremity_Multimodal_MEDLINE_April2014
Search run April 15, 2014 in Ovid MEDLINE(R) 1946 to April Week 1 2014; 5024 results; search run in Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations April 14, 2014; 58 results
1.
exp Lower Extremity/
2.
exp Hip Injuries/
3.
exp Leg Injuries/
4.
exp Knee Injuries/
5.
exp Foot/
6.
exp Toes/in [Injuries]
7.
exp Knee Joint/
8.
exp Foot Bones/
9.
Anterior Cruciate Ligament/
10.
Posterior Cruciate Ligament/
11.
exp Collateral Ligaments/
12.
Ankle Injuries/
13.
Ankle Joint/
14.
Ankle/
15.
Lateral Ligament, Ankle/in [Injuries]
16.
Fasciitis, Plantar/
17.
(lower adj3 (extremit* or limb* or injur*)).ab,ti.
18.
(ankle* adj3 (sprain* or strain* or injur*)).ab,ti.
19.
((talofibular or calcaneofibular or calcaneotibial or tibio*) adj3 (sprain* or strain* or injur*)).ab,ti.
20.
(deltoid adj3 ankle*).ab,ti.
21.
(fibularis adj3 strain*).ab,ti.
22.
((peroneal or peroneus) adj3 strain*).ab,ti.
23.
((tibialis and strain*) adj3 (anterior or posterior)).ab,ti.
24.
(band syndrome adj3 (illiotibial or IT)).ab,ti.
25.
achilles.ab,ti.
26.
(ACL or LCL or MvCL or PCL).ab,ti.
27.
"adductor muscle*".ab,ti.
28.
"collateral ligament*".ab,ti.
29.
gastrocnemius.ab,ti.
30.
(gluteus or gluteal).ab,ti.
31.
"hamstring*".ab,ti.
32.
"hip flexor*".ab,ti.
33.
"hoffa* syndrome".ab,ti.
34.
iliofemoral.ab,ti.
35.
impingement.ab,ti.
36.
(buttock* adj4 (injur* or pain*)).ab,ti.
37.
(foot adj4 (injur* or pain*)).ab,ti.
38.
(hip* adj4 (injur* or pain*)).ab,ti.
39.
(knee* adj4 (injur* or pain*)).ab,ti.
40.
(leg* adj4 (injur* or pain*)).ab,ti.
41.
(thigh* adj4 (injur* or pain*)).ab,ti.
42.
(toe* adj4 (injur* or pain* or turf)).ab,ti.
43.
ischiofemoral.ab,ti.
44.
"metatars*".ab,ti.
45.
"patellofemoral pain syndrome*".ab,ti.
46.
"patellar adj tendon*".ab,ti.
47.
popliteus.ab,ti.
48.
pubofemoral.ab,ti.
49.
"quadricep*".ab,ti.
50.
soleus.ab,ti.
51.
talocrural.ab,ti.
52.
"tarsal*".ab,ti.
53.
tendinosis.ab,ti.
54.
tendinopathy.ab,ti.
55.
(plantar adj fasciitis).ab,ti.
56.
tibialis.ab,ti.
57.
or/1-56
58.
Combined Modality Therapy/
59.
Pragmatic Clinical Trials as Topic/
60.
(pragmatic adj3 (randomized clinical trial or RCT or approach*)).ab,ti.
61.
"physical adj modalit*".ab,ti.
62.
(team* adj3 (care or health or healthcare or medical)).ab,ti.
63.
(grouped adj3 (care or approach)).ab,ti.
64.
(care adj3 (package or packages)).ab,ti.
65.
(collaborat* adj3 (treatment* or therap* or care or procedure* or approach or rehabilitat*)).ab,ti.
66.
(combined adj3 (treatment* or therap* or care or procedure* or approach or rehabilitat*)).ab,ti.
67.
(comprehensive adj3 (treatment* or therap* or care or procedure* or approach or rehabilitat*)).ab,ti.
68.
(integrated adj3 (treatment* or therap* or care or procedure* or approach or rehabilitat*)).ab,ti.
69.
(disciplin* adj3 (approach or care)).ab,ti.
70.
(pragmatic adj3 (approach or care)).ab,ti.
71.
((multicentre* or multi-centre* or multicenter* or multi-center*) adj4 (treatment* or therap* or care or procedure* or approach* or rehabilitat*)).ab,ti.
72.
Multicenter Study.pt.
73.
or/58-72
74.
(treatment* or therap* or care or procedure* or approach or rehabilitat*).ab,ti.
75.
(co-ordinat* or coordinat*).ab,ti.
76.
(multimodal* or multi-modal* or multi modal*).ab,ti.
77.
(interdisciplin* or inter-disciplin* or inter disciplin*).ab,ti.
78.
(interprofessional or inter-professional).ab,ti.
79.
(multidisciplin* or multi-disciplin* or multi disciplin*).ab,ti.
80.
or/75-79
81.
74 and 80
82.
73 or 81
83.
Randomized Controlled Trials as Topic/
84.
Controlled Clinical Trials as Topic/
85.
Clinical Trials as Topic/
86.
exp Case-Control Studies/
87.
exp Cohort Studies/
88.
Double-Blind Method/
89.
Single-Blind Method/
90.
Placebos/
91.
randomized controlled trial.pt.
92.
controlled clinical trial.pt.
93.
comparative study.pt.
94.
(meta analys* or meta-analys* or metaanalys*).ab,ti.
95.
(cohort and (study or studies or analys*)).ab,ti.
96.
(random* and (control* or clinical or allocat*)).ab,ti.
97.
(case adj control*).ab,ti.
98.
((double or single) and blind*).ab,ti.
99.
"placebo*".ab,ti.
100.
(comparative and (study or studies)).ab,ti.
101.
or/83-100
102.
57 and 82 and 101
103.
limit 102 to (english language and humans and yr="1990 -Current")
References
Gerbino PG
Griffin ED
d'Hemecourt PA
et al.
Patellofemoral pain syndrome: evaluation of location and intensity of pain.
The 6-year trajectory of non-traumatic knee symptoms (including patellofemoral pain) in adolescents and young adults in general practice: a study of clinical predictors.
Is multimodal care effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
Are work disability prevention interventions effective for the management of neck pain or upper extremity disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
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.
The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network.
How well are you recovering? The association between a simple question about recovery and patient reports of pain intensity and pain disability in whiplash-associated disorders.
Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial.
Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.
Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial.
The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: a systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.
P < .05, data not provided.
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