Chiropractic Management of Fibromyalgia Syndrome: A Systematic Review of the Literature

Article Outline

• Abstract
• Methods
  • Search Strategy
  • Evaluation and Rating Systems
• Results
  • Systematic Reviews and Meta-Analyses of the FMS Literature
  • Published Guidelines Found on the NGC
  • Additional Searches for FMS Controlled Clinical Trials
  • Search of the MANTIS and ICL Databases
• Discussion
• Conclusions
• Acknowledgment
• References
• Copyright

Abstract 

Objective

Fibromyalgia syndrome (FMS) is one of the most commonly diagnosed nonarticular soft tissue conditions in all fields of musculoskeletal medicine, including chiropractic. The purpose of this study was to perform a comprehensive review of the literature for the most commonly used treatment procedures in chiropractic for FMS and to provide evidence ratings for these procedures. The emphasis of this literature review was on conservative and nonpharmaceutical therapies.

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. Online comprehensive literature searches were performed of the following databases: Cochrane Database of Systematic Reviews; National Guidelines Clearinghouse; Cochrane Central Register of Controlled Trials; Manual, Alternative, and Natural Therapy Index System; Index to Chiropractic Literature, Cumulative Index to Nursing and Allied Health Literature; Allied and Complementary Medicine; and PubMed up to June 2006.

Results

Our search yielded the following results: 8 systematic reviews, 3 meta-analyses, 5 published guidelines, and 1 consensus document. Our direct search of the databases for additional randomized trials did not find any chiropractic randomized clinical trials that were not already included in one or more of the systematic reviews/guidelines. The review of the Manual, Alternative, and Natural Therapy Index System and Index to Chiropractic Literature databases yielded an additional 38 articles regarding various nonpharmacologic therapies such as chiropractic, acupuncture, nutritional/herbal supplements, massage, etc. Review of these articles resulted in the following recommendations regarding nonpharmaceutical treatments of FMS. Strong evidence supports aerobic exercise and cognitive behavioral therapy. Moderate evidence supports massage, muscle strength training, acupuncture, and spa therapy (balneotherapy). Limited evidence supports spinal manipulation, movement/body awareness, vitamins, herbs, and dietary modification.

Conclusions

Several nonpharmacologic treatments and manual-type therapies have acceptable evidentiary support in the treatment of FMS.

Key Indexing Terms: Fibromyalgia, Chiropractic, Fatigue Syndrome, Chronic

Fibromyalgia syndrome (FMS) is an elusive condition of unknown etiology, in which patients report chronic widespread pain as their predominant symptom, along with a variety of other complaints including fatigue, sleep disorders, cognitive deficit, irritable bowel and bladder syndrome, headache, Raynaud syndrome, bruxism, atypical patterns of sensory dysesthesia, and other symptoms.¹ The name of the condition, fibro-myo-algia, suggests that the widespread pain is emanating from the fibrous soft tissues or muscles. However, the literature is void of data to support the hypothesis that FMS is a distinct pathologic disorder of the soft tissues. More recent data tend to support the notion that FMS is a disorder of the central nervous system pain processing pathways and not some type of primary autoimmune disorder of the peripheral tissues.², ³, ⁴

The diagnosis of FMS has been burdened by a controversial and problematic history since its inception in 1990, with a disturbing trend toward overdiagnosis in recent years.⁵ Chiropractors, who often see chronic pain patients who have exhausted all other conservative treatment options, need to be wary of the diagnosis of FMS. The mere presence of widespread pain and fatigue should not be considered adequate grounds for making a de facto diagnosis of FMS; yet many times, this is the case. The primary symptoms of FMS, that is, widespread pain and fatigue, are also the primary symptoms of a number of other medical conditions including hypothyroidism, anemia, diabetes, Lyme disease, rheumatoid arthritis, undiagnosed cancer, posttraumatic myofascial pain, and many other conditions.

The issue of overdiagnosis and misdiagnosis relates back to the simple fact that a diagnosis of FMS is not based upon any laboratory or diagnostic tests, but rather upon symptoms that have been divided into 2 vague criteria. The first criterion is a history of chronic widespread pain, and the second criterion is the presence of a specific number of tender points (TePs) that exhibit a painful response to less than 4 kg of manual pressure.⁶ Although a diagnosis of FMS is predicated upon the presence of multiple TePs, the etiology of these areas of superficial tenderness is not known. The FMS literature contains biopsy studies of TePs that have failed to show any soft tissue abnormality that is specific to FMS patients.⁷ It is clear that TePs are not areas of soft tissue inflammation, which explains the findings in the pharmaceutical literature that no steroidal or nonsteroidal anti-inflammatory medication has any significant effect on reducing the painful TePs in FMS patients above placebo.

The hallmark symptom of FMS is pronounced tenderness to even the mildest palpation. This extreme tenderness to subthreshold stimuli fits the definition of allodynia, that is, the perception of pain to a nonpainful stimulus.⁸ Allodynia and/or hyperalgesia can be quite pronounced in the classic presentation of FMS; it has been found to be multimodal (pressure, heat, electrical stimulation) and widespread throughout many body regions.⁹, ¹⁰, ¹¹ The presence of allodynia typically implies a disorder of nociceptive pathways within the central nervous system (central sensitization) and not an abnormality of peripheral tissues themselves. There are recent data to support the idea that the widespread allodynia associated with FMS is indeed caused by central nervous system dysfunction (central sensitization) as documented by functional magnetic resonance imaging and positron emission tomography brain scans of patients with FMS receiving innocuous sensory stimulation.¹², ¹³

Leading FMS researchers now consider the TeP phenomenon to merely be the peripheral manifestation (widespread allodynia) of a central nervous system dysfunction. Several consensus conferences have addressed the issue of FMS diagnosis and treatment since the publication of the original 1990 American College of Rheumatology (ACR) criteria and have reported numerous other symptoms besides the 2 ACR criteria of widespread pain and multiple TePs.¹⁴, ¹⁵, ¹⁶ Fibromyalgia syndrome patients are predominantly female (female-male ratio, 10-20:1); typically report nonrefreshing sleep, general fatigue, and low energy; and experience concomitant anxiety and depression disorders. Fibromyalgia syndrome is reported to be part of a wider syndrome involving headaches, bruxism, irritable bladder, irritable bowel, sleep disorders, depression and/or anxiety disorders, cold sensitivity, Raynaud phenomenon, exercise intolerance, cognitive deficit, and other symptoms suggestive of autonomic nervous system and/or neuroendocrine dysregulation.

The most updated FMS protocols still recommend the same 2 ACR criteria as being mandatory for making an FMS diagnosis, along with a long list of additional clinical symptoms and signs that include the following: neurocognitive manifestations, fatigue, sleep dysfunction, autonomic and/or neuroendocrine manifestations, neurologic manifestations, and other symptoms. Some or all of these symptoms may be found along with the hallmark finding of widespread allodynia. Fibromyalgia syndrome researchers are starting to look at a new conceptual model of FMS as a disorder with multiple subsets and potentially multiple treatment approaches.

The notion that FMS represents a single diagnostic entity is now being challenged by newer hypotheses that various subsets of FMS may exist.¹⁶, ¹⁷ Fibromyalgia syndrome is more likely to be a syndrome that may have a number of different etiologies, requiring a number of different treatment approaches. Our review of the FMS literature is consistent with this emerging idea of FMS being composed of numerous subsets. As the reader reviews the following evidence rating tables, practice guidelines, and literature syntheses, it will become apparent that a number of different treatment approaches seem to show therapeutic promise and that no one single treatment or “silver bullet” approach is appropriate for the clinical management of FMS.

In the field of FMS, chiropractic is generally regarded as one of the complementary and alternative medical (CAM) therapies. Complementary and alternative medical therapies are commonly used in the treatment of FMS, and there is considerable overlap between chiropractic manipulative and manual approaches and other CAM therapies in this field. For example, many chiropractors use therapeutic exercises, vitamins, herbs, and dietary modifications in the management of FMS. The emerging FMS literature is showing promise for many CAM therapies, as no single therapeutic intervention has been shown to be curative. The trend in the clinical management of FMS syndrome is to treat the various symptoms of the syndrome using a number of different interventions, including CAM therapies. This trend fits well with the traditional chiropractic perspective that health and well-being require a “combination approach” to clinical management.

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Methods 

Search Strategy 

The search strategy for this literature review was focused on conservative nonpharmaceutical treatments for FMS, including chiropractic manipulative therapy. Therefore, our search included any conservative therapy that might be included within the scope of chiropractic practice, in addition to spinal manipulation. Articles that were opinion pieces, hypotheses, extrapolations from basic science research, and other nonobservational types of articles were excluded from our review.

We used a systematic approach to reviewing the FMS literature by following this sequence of online searching strategies:

The keywords used in our search strategy included the terms fibromyalgia, fibrositis, and fibromyalgia syndrome and covered the literature published in the English language between 1966 and 2006. We did not restrict the searches by using the term chiropractic, with the exception of one of the searches within the specific confines of the MANTIS and ICL databases. The titles of all retrieved studies were reviewed for their relevance to chiropractic practice and scope, and the abstracts of any potentially relevant studies were further reviewed before obtaining full text copies of the entire article. Studies that involved injection, medication, surgery, or other invasive therapies were excluded from our review. We did include 2 systematic reviews of the antidepressant medication literature because this class of medication is considered an integral component of the standard medical management of FMS syndrome, albeit outside the scope of chiropractic practice.

A manual review of the reference lists of the previously noted Cochrane systematic reviews and meta-analyses and the NGC practice guidelines found that the most recent of these publications had searched the FMS literature through the year 2002. We therefore performed our own searches for additional controlled trials using the keywords fibromyalgia and fibromyalgia syndrome between the years January 2000 and June 2006 on the following databases: MEDLINE, CINAHL, AMED, Cochrane Central Register of Controlled Trials, and PubMed. The rationale for going back to the year 2000 was to confirm that we did not miss any relevant studies and to provide some overlap for comparison with the references contained in the search strategies of the previously reported FMS systematic reviews, meta-analyses, and practice guidelines. Our intent was to attempt to find any additional clinical trials that were not included in the reviews performed by the previous meta-analyses and systematic reviews by cross-referencing our list against the list of references from the prior studies.

In addition to searching these standard online databases for randomized controlled trials, we specifically wanted to capture any type of chiropractic literature, including observational studies, that might have been published in nonindexed journals. Therefore, we specifically performed another comprehensive search of the MANTIS and ICL databases, which are more inclusive of the chiropractic and CAM therapy literature. We used 2 search strategies on these databases. First, we performed a wide search using the terms fibromyalgia and fibromyalgia syndrome without any restrictions to journal type, but restricted the year of publication from 1990 to 2006, The rationale for this search strategy was simple: 1990 is generally considered the inaugural year for fibromyalgia becoming officially recognized as a diagnosis by virtue of publication of the ACR criteria for diagnosis of FMS. Our second search strategy was to use the keywords fibromyalgia AND chiropractic for the years of publication from 1950 to 2006. We also used reference tracking to ensure that the search was comprehensive.

Evaluation and Rating Systems 

As relevant studies were identified, we obtained full text versions of the articles and reviewed them using several recognized protocols. The systematic reviews, meta-analyses, and randomized trials were reviewed using the Oxford Rating Scale developed by the Centre for Evidence-Based Medicine (http://www.library.utoronto.ca/medicine/ebm) and the appropriate evidence rating checklists developed by the Scottish Intercollegiate Guidelines Network (SIGN) (http://www.sign.ac.uk/methodology/index.html), shown in Figure 1. There are separate SIGN checklists for each type of experimental and higher-quality observational studies. The guidelines retrieved from the NGC were evaluated using the appraisal instrument/checklist developed by the Appraisal of Guidelines for Research and Evaluation (AGREE) Collaboration (www.agreecollaboration.org).

Fig 1. Rating scales for studies obtained from MANTIS and ICL searches.

A. The Oxford Rating Scale (http://www.library.utoronto.ca/medicine/ebm/)

1a: Systematic review with homogeneity of RCTs

1b: Individual RCT with narrow confidence interval

2a: Systematic review with homogeneity of cohort studies

2b: Individual cohort study or low-quality RCT

3a: Systematic review with homogeneity of case-control studies

3b: Individual case-control study

4: Case series, low-quality cohort or case-control studies

5: Expert opinion

B. The SIGN Checklist (http://www.sign.ac.uk/methodology/index.html)

1. ++ = All or most methodological criteria have been fulfilled/bias has been maximally reduced.

2. + = Some of the criteria have been fulfilled/bias has been somewhat reduced.

− = Few or no criteria fulfilled/bias is clearly present.

Finally, after summarizing the literature into evidence tables, we developed some evidence rating tables based upon our interpretation and evaluation of the quality of this literature. The evidence rating tables followed a standard format suggested by the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) (http://www.ccgpp.org) as outlined in Figure 2.

Fig 2. Council on Chiropractic Guidelines and Practice Parameters protocol for grading of recommendations (http://www.ccgpp.org).

Grade A: good evidence from relevant studies:

•Studies based on appropriate research designs of sufficient strength to answer the questions addressed.

•Results are both clinically important and consistent with minor exceptions at most.

•Results are free of any significant doubts about generalizability, bias, and flaws in research design.

•Studies with negative results have sufficiently large sample sizes to have adequate statistical power.

Grade B: fair evidence from relevant studies:

•Studies based on appropriate research designs of sufficient strength, but with some uncertainty due to inconsistencies in results, or minor doubts about generalizability, bias, design flaws, or sample size.

•Results from weaker designs, but confirmed in separate studies.

Grade C: limited evidence:

•Studies of appropriate design, but substantial uncertainty due to inconsistencies in results or due to serious doubts about generalizability, bias, research design flaws, or adequacy of sample size.

•Results from a limited number of studies or because of weak design for answering the question addressed.

Grade D: expert opinion, and usual and customary practice:

•Evidence from expert opinion only; research cannot be or has not been done.

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Results 

Systematic Reviews and Meta-Analyses of the FMS Literature 

Our search of the Cochrane Database of Systematic Reviews (1996-2005) using keywords fibromyalgia, fibrositis, and fibromyalgia syndrome identified a total of 26 references in this database. After reviewing the abstracts, we found that only 11 of these studies reviewed conservative therapies that were directly related to the subject of FMS or widespread pain. Of relevance to chiropractic practice were 8 systematic reviews¹⁸, ¹⁹, ²⁰, ²¹, ²², ²³, ²⁴, ²⁵ and 3 meta-analyses²⁶, ²⁷, ²⁸ of the FMS literature. These 11 references are listed in Table 1, along with the guidelines we obtained from the NGC. All were found to be of extremely high scholarly quality.

Table 1. Systematic reviews, meta-analyses, and practice guidelines

These references were found upon searching the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, and American College of Physicians Journal Club (for the years 1996-2006) and the NGC.

Of the above-noted 8 relevant systematic reviews of the FMS literature, the one that is most pertinent to chiropractic practice was published by Holdcraft et al.¹⁹ This systematic review was further updated and expanded into a clinical practice guideline document published by the American Pain Society (APS) a few years later and will be discussed shortly. The Holdcraft et al systematic review of the literature specifically assessed the effectiveness of CAM therapies for people with FMS. They searched the following online databases: MEDLINE (1975-2002), BIOSIS Previews (1975-2002), EMBASE (1990-2002), CINAHL (1982-1998), Alternative Medicine Alert, and the Cochrane Controlled Trials Register. They reviewed a large number of studies, encompassing a wide variety of various nonpharmacologic therapies including the following: acupuncture (8 studies including 2 RCTs with 130 patients), chiropractic (1 RCT with 19 patients), magnesium (2 crossover RCTs with 39 patients), S-adenosyl-l-methionine (1 review of 7 studies including 4 RCTs), chlorella (1 crossover RCT with 37 patients), relaxation (1 unblinded RCT with 55 patients), biofeedback (3 RCTs with 274 patients), magnet therapies (2 RCTs with 144 patients), homeopathy (1 crossover RCT with 30 patients), botanical oils (1 RCT with 30 patients), balneotherapy (1 RCT with 48 patients), anthocyanidins (1 crossover RCT with 12 patients), and dietary modifications (1 RCT with 78 patients).

They concluded that most of these CAM studies had several methodological limitations: no washout period in crossover RCTs, small sample sizes, lack of blinding, analysis not conducted on an intention-to-treat basis, no appropriate control condition, and lack of an assessment of the long-term outcomes. They commented that there was strong evidence of the effectiveness of acupuncture, with all 8 studies showing that acupuncture improved the symptoms of FMS. There was moderate evidence for the effectiveness of the nutritional supplement S-adenosyl-l-methionine, with limited but potentially promising evidence for the remaining CAM therapies listed above.

Published Guidelines Found on the NGC 

Our search of the NGC database produced a total of 5 published guidelines on the management of FMS.²⁹, ³⁰, ³¹, ³², ³³ Three of the guidelines²⁹, ³⁰, ³¹ were rated with the AGREE Instrument as “recommended,” and the other 2 guidelines³², ³³ were rated as “strongly recommended.” We found that, of the 2 strongly recommended guidelines, the most current (2005) FMS guideline published by the APS³³ was very comprehensive, of excellent quality, and inclusive of most nonpharmacologic and CAM therapies, including chiropractic. These guidelines will each be reviewed briefly below, with these references listed in Table 1 along with the previously noted systematic reviews and meta-analyses.

One guideline exists regarding FMS and work-related injury, from the Washington State Department of Labor and Industries.²⁹ This guideline states that FMS is not considered to be an occupational disease based upon their review of the scientific literature that failed to establish a causal relationship between a traumatic injury or occupational exposure and the development of FMS. Under special circumstances, the Department may authorize temporary treatment of FMS; but such treatment is limited to physical therapy, low-dose antidepressant and muscle relaxant medication, and spinal manipulations. Trigger point injections, methotrexate, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDs) are not approved for the treatment of FMS by the Department.

One FMS clinical guideline was found on the NGC Web site that was published in 2004 by Intracorp,³⁰ a public for-profit organization that had its internal medical technology and quality assurance committees review the FMS literature. They generated the following recommendations regarding the clinical management of FMS: recommended—exercise, education, low-dose antidepressants and analgesic medications, heat, and gentle massage; not recommended—steroids and NSAIDs.

The University of Texas School of Nursing published a guideline³¹ for the treatment of FMS in 2005 that suggests a stepwise approach as summarized below:

Another guideline for the management of FMS was authored by Goldenberg et al³² and published in the JAMA in 2004. This guideline was developed by an independent panel of experts who convened under the sponsorship of the APS and performed a comprehensive review of the FMS literature. They produced a consensus document/guideline based upon the best available evidence. Their conclusions were that the FMS diagnosis first must be confirmed and the condition explained to the patient and family. Any comorbid illness, such as mood disturbances or primary sleep disturbances, should be identified and treated. Medications for initial consideration are low doses of tricyclic antidepressants or cyclobenzaprine. Some selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or anticonvulsants may become first-line FMS medications as more RCTs are reported. All patients with FMS should begin a cardiovascular exercise program. Most patients will benefit from cognitive behavioral therapy (CBT) or stress reduction with relaxation training. A multidisciplinary approach combining each of these modalities may be the most beneficial. Other medications, such as tramadol or combinations of medications, should be considered. Patients with FMS not responding well to these steps should be referred to a rheumatologist, physiatrist, psychiatrist, or pain management specialist.

The most current of all the FMS guidelines identified by our search (as of June 2006) was authored by Buckhardt et al³³ and published by the APS in 2005. We found this guideline to be very comprehensive, well written, and applicable to a wide variety of different clinicians, including the chiropractic profession. It basically offers recommendations for the management of FMS according to the 3 most strongly evidence-based therapies described in most of the Cochrane systematic reviews, that is, low-dose antidepressant medications, aerobic exercise, and CBT.

The 2005 APS guideline further suggests that physicians should consider the option of having their patients try other complementary treatments such as acupuncture, biofeedback, chiropractic manipulation, hypnosis, and massage. They cautioned against the use of the following procedures for which there is no evidence of therapeutic efficacy in the treatment of FMS: opioids, corticosteroids, nonsteroidal anti-inflammatories, benzodiazepines, and tender or trigger point injections.

The most important conclusions and recommendations from the 2005 APS guideline for FMS are summarized below.

We rated the 2005 APS guideline as the highest-quality guideline we reviewed using the AGREE Instrument and considered it to be the most complete and comprehensive guideline for the clinical management of FMS that was currently available at the conclusion of our literature search in June 2006. We highly recommend that the serious reader of the FMS literature obtain a copy of this guideline. Most of our summary ratings agree with the ratings found within this guideline.

Additional Searches for FMS Controlled Clinical Trials 

Our search for additional randomized controlled trials on the MEDLINE, CINAHL, AMED, Cochrane Central Register of Controlled Trials, and PubMed databases yielded a total of 44 studies,³⁴, ³⁵, ³⁶, ³⁷, ³⁸, ³⁹, ⁴⁰, ⁴¹, ⁴², ⁴³, ⁴⁴, ⁴⁵, ⁴⁶, ⁴⁷, ⁴⁸, ⁴⁹, ⁵⁰, ⁵¹, ⁵², ⁵³, ⁵⁴, ⁵⁵, ⁵⁶, ⁵⁷, ⁵⁸, ⁵⁹, ⁶⁰, ⁶¹, ⁶², ⁶³, ⁶⁴, ⁶⁵, ⁶⁶, ⁶⁷, ⁶⁸, ⁶⁹, ⁷⁰, ⁷¹, ⁷², ⁷³, ⁷⁴, ⁷⁵, ⁷⁶, ⁷⁷ of which 25 were found to be relevant and not previously included in prior systematic reviews or meta-analyses. The other 19 studies were previously considered within the context of at least one or more of the systematic reviews listed in Table 1. These 44 references are summarized in Table 2. Of these 44 studies, the largest number of RCTs (n = 14) was of various exercise interventions for FMS symptoms, 7 of which were included in prior systematic reviews. Because exercise is already an established treatment of FMS, these additional 7 exercise studies do not change any recommendations from the previously noted systematic reviews. There were no additional clinical trials pertaining to chiropractic treatment or management of FMS. We retrieved 5 trials on vitamins and on nutritional and dietary interventions; however, all of these studies were included in previous systematic reviews and practice guidelines. A total of 19 studies of the 44 references (Table 2) found during our search were previously included in the reference sections of prior systematic reviews or practice guidelines and therefore were considered redundant.

Table 2. Additional clinical trials

These 44 references were found upon additional searches of the Medline, PubMed, CINAHL, AMED, EMBASE, Database of Abstracts of Reviews of Effects, and TRIP databases for the years 2000 to 2006. These represent the FMS literature for individual clinical trials that could potentially have been omitted from the previously retrieved systematic reviews and practice guidelines. Note that a total of 20 of these 44 references were included in the most recent FMS practice guideline³³ and systematic review¹⁹ of the FMS literature. No additional chiropractic trials were found on any of these medical databases.

The 25 studies that we found that were not previously considered in any of the prior systematic reviews or practice guidelines are listed in Table 2. We used the Oxford Rating Scale⁷⁸, ⁷⁹ as well as the SIGN Checklist, as summarized in Figure 1, to rate the quality of these clinical trials. The additional studies that have the most potential relevance to chiropractic practice, which are of reasonably good scientific quality, are the following (SIGN/Oxford ratings are presented in parentheses): osteopathic manipulation (1 small pilot RCT [1+/2b]), massage therapy (2 small RCTs [2+/2b]), laser therapy (1 small RCT [1+/2b]), spa water therapy/balneotherapy (1 moderate-sized RCT [(1+/1b]), and ultrasound and interferential current (1 small RCT [1+/2b]).

The results of our search for clinical trials from 2000 to 2006 basically confirm the previously summarized findings and conclusions of the Cochrane systematic reviews and meta-analyses of FMS literature, as well as the most recently published practice guidelines on the clinical management of FMS. We concluded that the 25 additional studies we found and rated would not substantially alter any of the recommendations made in any of the current published FMS practice guidelines, systematic reviews, or meta-analyses.

Search of the MANTIS and ICL Databases 

Our combination of 2 search strategies of the MANTIS and ICL databases from 1990 to 2006 produced a total of 701 citations, most of which were found to be opinion papers, hypotheses, anecdotal reports, and other types of narrative publication. Thirty-eight studies did meet our liberal inclusion criteria of being at minimum a single-case report, case series, or other type of acceptable observational study. We accepted any published observational study, regardless of whether it was published in a peer- or non–peer-reviewed journal.

A total of 38 articles⁸⁰, ⁸¹, ⁸², ⁸³, ⁸⁴, ⁸⁵, ⁸⁶, ⁸⁷, ⁸⁸, ⁸⁹, ⁹⁰, ⁹¹, ⁹², ⁹³, ⁹⁴, ⁹⁵, ⁹⁶, ⁹⁷, ⁹⁸, ⁹⁹, ¹⁰⁰, ¹⁰¹, ¹⁰², ¹⁰³, ¹⁰⁴, ¹⁰⁵, ¹⁰⁶, ¹⁰⁷, ¹⁰⁸, ¹⁰⁹, ¹¹⁰, ¹¹¹, ¹¹², ¹¹³, ¹¹⁴, ¹¹⁵, ¹¹⁶, ¹¹⁷ were selected from the MANTIS and ICL databases using the keywords fibromyalgia and fibromyalgia AND chiropractic. These 38 articles are summarized in Table 3 and consist of the following types of studies: 17 clinical trials, 17 case reports and/or case studies, 2 case-control studies, and 2 survey-type studies.

Table 3. Additional studies from MANTIS and ICL searches

These 38 references were obtained from literature searches of the MANTIS and ICL databases from 1950 to 2006. These 2 databases are not restricted to peer-reviewed, indexed journals. Only 3 of these studies were included in the most recent systematic review of the FMS literature¹⁹ and FMS practice guideline³³ (Blunt et al,⁸⁰ Deluze et al,⁸⁸ and Abraham and Flechas⁹⁷). EMG, Electromyography.

Reference tracking was used to look for potential overlap of references from the MANTIS and ICL searches. Three of the studies found from our MANTIS and ICL searches were included in the most recent systematic review¹⁹ of the FMS literature and FMS practice guideline³³ (Blunt et al,⁸⁰ Deluze et al,⁸⁸ and Abraham and Flechas⁹⁷). Therefore, 35 articles were found that represented unique and separate contributions to the FMS literature. Expanded summaries of all these studies are listed in Table 4, along with their respective Oxford/SIGN ratings. Regarding chiropractic treatment of FMS, we found 1 additional RCT,⁸¹ 1 case-series report,¹¹⁵ and 1 single-case report.¹¹⁴ The RCT describing chiropractic treatment of FMS was published in the World Federation of Chiropractic seventh biennial congress conference proceedings,⁸¹ which consisted of a very scant description of the study and results. A hand search for a detailed full text peer-reviewed version of this study was attempted, but we could not find any full text peer-reviewed publication of this study.

Table 4. Summaries of additional studies

Expanded summaries of results of literature search on MANTIS and ICL databases using the keywords fibromyalgia (1990-2006) and fibromyalgia AND chiropractic (1950-2006). The explanation of SIGN/Oxford rating protocol is in Figure 1. AE, Aerobic exercise; TENS, transcutaneous electrical nerve stimulation; SM, stress management; WFC, World Federation of Chiropractic; OMT, osteopathic manipulative treatment; RA, rheumatoid arthritis.

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Discussion 

A consistent theme emerges from all of the systematic reviews, meta-analyses, and practice guidelines that we reviewed: there is no known cause or etiologic agent(s) responsible for the development of the symptom complex known as FMS. All treatment options are merely directed toward amelioration of the major symptoms of widespread pain and fatigue, and are not expected to cure the condition. Most systematic reviews have concluded that 3 basic therapies have the strongest and most established evidence base with respect to treatment of FMS:

It is interesting to note that 2 of the 3 published meta-analyses were on the subject of antidepressant medications, which are not directly applicable to chiropractic practice. At first glance, this seems to contradict our search strategy to focus on nonpharmacologic FMS therapies. However, we decided to include these 2 medication meta-analyses in our review because the use of low-dose antidepressant medications is considered by all major guidelines to be 1 of the 3 most evidence-based treatments for FMS (see bullets above). Therefore, we thought it important to include these studies for completeness and to provide a brief synthesis of this literature for the reader's convenience.

We found that the 2005 APS guideline³³ provided the most comprehensive review of the literature and best evidence synthesis to date, which was inclusive of all the pertinent chiropractic and CAM literature. We strongly recommend that clinicians consult this guideline for the most current evidence synthesis and best practices document regarding the clinical management of FMS. After careful review of the additional studies we retrieved from searches of several standard databases, as well as MANTIS and ICL, we could not find any compelling new evidence that would substantially alter the recommendations presented in the most current systematic reviews, meta-analyses, and practice guidelines.

Although we formally concluded our search of the FMS literature in June 2006, we did review the recently published guidelines by the European League Against Rheumatism (EULAR) in 2007 that gave evidence tables for the management of FMS.¹¹⁸ The 2007 EULAR guidelines essentially recommend the same medications as those in the 2005 APS guidelines, with the addition of strong evidence for SNRIs, tramadol, gabapentin, and pregabalin. All of these medications were given the highest evidence rating by the EULAR panel. It is interesting to note the ratings of the nonpharmaceutical treatments recommended: medium evidence for heated pool treatments (balneotherapy), weak evidence for aerobic and strength exercises, weak evidence for relaxation and psychologic support, and poor evidence for CBT. These nonpharmaceutical ratings are somewhat contradictory to the APS ratings and evidence tables. The EULAR guidelines did not specifically provide any rating for spinal manipulation or chiropractic care.

It was very surprising to find such a paucity of chiropractic literature about the clinical management of FMS, considering that chiropractors frequently report that they treat FMS patients. We were only able to find 4 relevant chiropractic clinical studies regarding FMS treatment in the MANTIS and ICL databases, for a total of 2 small clinical trials,⁸⁰, ⁸¹ 1 case series,¹¹⁴ and 1 single-case report.¹¹⁵ Only one of these chiropractic trials was of sufficient quality to be included in the APS guideline.⁸⁰ The other chiropractic trial⁸¹ was published only in the form of an expanded abstract as preliminary findings in conference proceedings, and we could not find any full text version of these findings in the peer-reviewed or non–peer-reviewed literature.

The National Board of Chiropractic Examiners has gathered data about chiropractic practice in the United States through surveys performed in 1991, 1998, and 2003. The results have been collectively published in a series of 3 texts known as the Job Analysis of Chiropractic, with the most recent version published in 2005.¹¹⁹ The 2005 Job Analysis of Chiropractic data revealed that 4 soft tissue conditions are reported by clinicians as “often” or “sometimes” seen in chiropractic practice: muscular strain/tear, tendinitis/tenosynovitis, myofascitis, and FMS.

Chiropractors report that they treat the first 3 conditions listed above “often” and without the need for medical co-management in about 75% to 80% of cases. In this regard, they act as the sole health care provider managing these cases. However, in the case of FMS, chiropractors report that they only see this condition “sometimes” and choose to co-manage this condition with another health care provider in about 55% to 64% of cases. These findings suggest that chiropractors feel very confident in their ability to manage muscle and tendon conditions, but much less confident in managing FMS by themselves as noted by the high rate of medical co-management.

The results of our literature synthesis were compiled into a summary of recommendations for the most evidence-based procedures for the clinical management of FMS as presented in Table 5. It is important to note that many of the therapies listed in our evidence ratings table are within the scope of chiropractic practice and show at least good to fair levels of evidence. However, the standard medical management of FMS still relies heavily on prescription medications, which are clearly outside the chiropractic scope of practice.

Table 5. Summary of recommendations for clinical management of FMS (protocol used to arrive at these recommendations is in Fig 2)

FIQ, Fibromyalgia Impact Questionnaire.

Yet the other 2 most evidence-based treatments for FMS, exercise and CBT, could be incorporated in most chiropractic practices. This requires an understanding of the importance of central sensitization as the key mechanism underlying the widespread allodynia found in FMS, and that patients need an active care approach to treatment that will incorporate both a mild exercise program with an empathetic bedside manner in which the chiropractor provides education, positive emotional support, and possible referral for group or individual psychologic counseling.

There is certainly a trend within the FMS literature to expand treatment and research efforts outside of the traditional allopathic model to include a number of CAM therapies that are within the scope of chiropractic practice. It would be desirable to see more chiropractic interest in developing high-quality experimental and observational research into this area. There is a great potential for future collaboration between chiropractic researchers and other professions to develop multidisciplinary approaches to the clinical management of FMS that involve CAM therapies under the umbrella of chiropractic care.

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Conclusions 

Most systematic reviews and guidelines all recommend 3 interventions as having the strongest evidence support: (1) low-dose antidepressant medications, (2) light aerobic exercise, and (3) CBT. Moderate evidence supports the use of massage, muscle strength training, acupuncture, and spa therapy (balneotherapy). Limited evidence supports spinal manipulation; movement/body awareness; and vitamins, herbs, and dietary modifications. Presently, there is no single therapy or intervention that can be considered a cure for FMS. Combinations of therapies appear to be most helpful, and future research seems to be looking toward strategies by which to find subgroups of FMS patients who might respond better to certain therapies. Our project stopped searching the literature as of June 2006, and newer evidence has surfaced since that time. The most recent studies would include the EULAR evidence-based recommendations for the management of FMS¹¹⁸ and a recently published narrative review of the mechanisms and pathophysiology of fibromyalgia.¹²⁰ These publications continue to provide evidence that FMS is not a peripheral disorder of the soft tissues, but rather a disorder of aberrant pain processing and central sensitization.

In conclusion, we found that there is an emerging literature regarding a number of CAM therapies for the conservative treatment of FMS syndrome, including spinal manipulation. There is a dearth of experimental chiropractic literature on the management of soft tissue conditions and FMS. It is recommended that the chiropractic research community take notice of this information gap and take steps to design high-quality experimental research studies to help close this information gap. Such research by the chiropractic profession could be an excellent opportunity to build bridges and collaborate with other health care professions and the scientific community.

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Acknowledgment 

The primary author and all coauthors are members of the soft tissue committee of the CCGPP commissioned to do this comprehensive review. None of the authors has received any financial support from the CCGPP for this study, and no competing financial interests are declared. The authors thank Tom Hyde who assisted us with review of full text manuscripts.

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