A SYSTEMATIC REVIEW OF THE LITERATURE

17
CHIROPRACTIC MANAGEMENT OF FIBROMYALGIA SYNDROME: A SYSTEMATIC REVIEW OF THE LITERATURE Michael Schneider, DC phD,a Howard Vemon. DC PhD.b Gordon Ko, MD,c Gordon Lawson, MSc. Dc,d and Jerome Perera€ 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 treatmenl 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 10 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 I 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. nutritionaVherbal 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 lraining. acupuncture, and spa therapy (balneotherapy). Limited evidence supports spinal manipulation, movementlbody awareness. vitamins, herbs, and dietary modification. Conclusions: Several nonphannacologic treatments and manual-type therapies have acceptable evidentiary support in the treatment of FMS. (J Manipulative Physiol Ther 2009:32:25-40) Key Indexing Terms: Fibromya/gia; Chiropracric; Farigllt' Syndrome; ChrQnic a Visiting Assistant Professor. School of Health and Rehabilita- tion Sciences, University of Pillsburgh, Pittsburgh, Pa. USA. b Professor, Graduate Education and Research, Canadian Mem- orial Chiropractic College, Toronto, Ontario, Canada. C Medical Director, Canadian Centre for Integrative Medicine, Physiatry Intervention Clinic, Sunnybrook Health Sciences Centre. University of Toronto, Toronto, Ontario, Canada. d Assistant Professor, Canadian Memorial Chiropractic College, Toronto, Ontario, Canada. e Student, School of Medicine.University of Toronto. Ontario, Canada. Submit requests for reprints to: Michael Schneider. DC. Assistant Professor and PhD candidate, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA (e-mail: d..mike@ci~1"-ner.com). Paper submitted April 29. 2008: in revised fonn July 10. 2008: accepted August JI, 2008. 0161-4754/534.00 Copyright .f 2009 by National University of Health Sciences. doi: I0.1 016/j.jmpt.2008.08.0J 2 F ibromyalgia 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. J The name of the condition, jibro-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.2-4 The diagnosis of FMS has been burdened by a controversial and problematic history since its inception in 25

Transcript of A SYSTEMATIC REVIEW OF THE LITERATURE

CHIROPRACTIC MANAGEMENT OF FIBROMYALGIA SYNDROME:

A SYSTEMATIC REVIEW OF THE LITERATURE

Michael Schneider, DC phD,a Howard Vemon. DC PhD.b Gordon Ko, MD,cGordon Lawson, MSc. Dc,d and Jerome Perera€

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 treatmenl 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 10 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 I

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. nutritionaVherbal

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 lraining. acupuncture, and spa therapy (balneotherapy). Limited

evidence supports spinal manipulation, movementlbody awareness. vitamins, herbs, and dietary modification.

Conclusions: Several nonphannacologic treatments and manual-type therapies have acceptable evidentiary support in

the treatment of FMS. (J Manipulative Physiol Ther 2009:32:25-40)

Key Indexing Terms: Fibromya/gia; Chiropracric; Farigllt' Syndrome; ChrQnic

a Visiting Assistant Professor. School of Health and Rehabilita-tion Sciences, University of Pillsburgh, Pittsburgh, Pa. USA.

b Professor, Graduate Education and Research, Canadian Mem-orial Chiropractic College, Toronto, Ontario, Canada.

C Medical Director, Canadian Centre for Integrative Medicine,Physiatry Intervention Clinic, Sunnybrook Health Sciences Centre.University of Toronto, Toronto, Ontario, Canada.

d Assistant Professor, Canadian Memorial Chiropractic College,Toronto, Ontario, Canada.

e Student, Schoolof Medicine.University of Toronto.Ontario,Canada.

Submit requests for reprints to: Michael Schneider. DC.Assistant Professor and PhD candidate, School of Health andRehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA,USA (e-mail: d..mike@ci~1"-ner.com).

Paper submitted April 29. 2008: in revised fonn July 10. 2008:accepted August JI, 2008.

0161-4754/534.00

Copyright .f 2009 by National University of Health Sciences.doi: I0.1 016/j.jmpt.2008.08.0J 2

Fibromyalgia syndrome (FMS) is an elusive conditionof unknown etiology, in which patients report chronicwidespread pain as their predominant symptom, along

with a variety of other complaints including fatigue, sleepdisorders, cognitive deficit, irritable bowel and bladdersyndrome, headache, Raynaud syndrome, bruxism, atypicalpatterns of sensory dysesthesia, and other symptoms. J Thename of the condition, jibro-myo-algia, suggests that thewidespread pain is emanating from the fibrous soft tissues ormuscles. However, the literature is void of data to support thehypothesis that FMS is a distinct pathologic disorder of thesoft tissues. More recent data tend to support the notion thatFMS is a disorder of the central nervous system painprocessing pathways and not some type of primaryautoimmune disorder of the peripheral tissues.2-4

The diagnosis of FMS has been burdened by acontroversial and problematic history since its inception in

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Fibromyalgia Syndrome

1990, with a disturbing trend toward overdiagnosis in recentyears.s Chiropractors, who often see chronic pain patientswho have exhausted all other conservative treatment options,need to be wary of the diagnosis ofFMS. The mere presenceof widespread pain and fatigue should not be consideredadequate grounds for making a de facto diagnosis of FMS;yet many times, this is the case. The primary symptoms ofFMS, that is, widespread pain and fatigue, are also theprimary symptoms of a number of other medical conditions

including hypothyr~idism, anemia, diabetes, Lyme disease,rheumatoid arthritis, undiagnosed cancer, posttraumaticmyofascial pain, and many other conditions.

The issue of overdiagnosis and misdiagnosis relatesback to the simple fact that a diagnosis of FMS is not basedupon any laboratory or diagnostic tests, but rather uponsymptoms that have been divided into 2 vague criteria. Thefirst criterion is a history of chronic widespread pain, andthe second criterion is the presence of a specific numberof tender points (TePs) that exhibit a painful response toless than 4 kg of manual pressure.6 Although a diagnosis ofFMS is predicated upon the presence of multiple TePs,the etiology of these areas of superficial tenderness is notknown. The FMS literature contains biopsy studies ofTePs that have failed to show any soft tissue abnorn1alitythat is specific to FMS patients.7 It is clear that TePs arenot areas of'soft tissue inflammation, which explains thefindings in the pharmaceutical literature that no steroidal ornonsteroidal anti-inflammatory medication has any signifi-cant effect on reducing the painful TePs in FMS patientsabove placebo.

The hallmark symptom ofFMS is pronounced tendernessto even the mildest palpation. This extreme tenderness tosubthreshold stimuli fits the definition of allod.-vnia,that is,the perception of pain to a nonpainful stimulus.s Allodyniaand/or hyperalgesia can be quite pronounced in the classicpresentation of FMS; it has been found to be multimodal(pressure, heat, electrical stimulation) and widespreadthroughout many body regions.9-11 The presence ofallodynia typically implies a disorder of nociceptive path-ways within the central nervous system (central sensitiza-tion) and not an abnormality. of peripheral tissuesthemselves. There are recent data to support the idea thatthe widespread allodynia associated with FMS is indeedcaused by central nervous system dysfunction (centralsensitization) as documented by functional magnetic reso-nance imaging and positron emission tomography brainscans of patients with FMS receiving innocuous sensorystimulation.12,13

Leading FMS researchers now consider the TePphenomenon to merely be the peripheral manifestation(widespread allodynia) of a central nervous systemdysfunction. Several consensus conferences have addressedthe issue of FMS diagnosis and treatment since thepublication of the original 1990 American College ofRheumatology (ACR) criteria and have reported numerous

Journal of Manipulative and Physiological TherapeuticsJanuary 2009

other symptoms besides the 2 ACR criteria of widespreadpain and multiple TePs.14-16 Fibromyalgia syndromepatients are predominantly female (female-male ratio, 10-20: I); typically report nonrefreshing sleep, general fatigue,and low energy; and experience concomitant anxiety anddepression disorders. Fibromyalgia syndrome is reported tobe part of a wider syndrome involving headaches, bruxism,irritable bladder, irritable bowel, sleep disorders, depressionand/or anxiety disorders, cold sensitivity, Raynaud phe-nomenon, exercise intolerance, cognirive deficit, and othersymptoms suggestive of autonomic nervous system and/orneuroendocrine dysregulation.

The most updated FMS protocols still recommend thesame 2 ACR criteria as being mandatory for making an FMSdiagnosis, along with a long list of additional clinicalsymptoms and signs that include the following: neuro-cognitive manifestations, fatigue, sleep dysfunction, auto-nomic and/or neuroendocrine manifestations, neurologicmanifestations, and other symptoms. Some or all of thesesymptoms may be found along with the hallmark finding ofwidespread allodynia. Fibromyalgia syndrome researchersare starting to look at a new conceptual modeLof FMS as adisorder with multiple subsets and potentially multipletreatment approaches.

The notion that FMS represents a single diagnosticentity is now being challenged by newer hypotheses thatvarious subsets of FMS may exist.lh.17 Fibromyalgiasyndrome is more likely to be a syndrome that may havea number of different etiologies, requiring a number ofdifferent treatment approaches. Our review of the FMSliterature is consistent with this emerging idea of FMSbeing composed of numerous subsets. As the readerreviews the following evidence rating tables, practiceguidelines, and literature syntheses, it will becomeapparent that a number of different treatment approachesseem to show therapeutic promise and that no one singletreatment or "silver bullet" approach is appropriate for theclinical management of FMS.

In the field of FMS, chiropractic is generally regarded asone of the complementary and alternative medical (CAM)therapies. Complementary and alternative medical therapiesare commonly used in the treatment of FMS, and there isconsiderable overlap between chiropractic manipulativeand manual approaches and other CAM therapies in thisfield. For example, many chiropractors use therapeuticexercises, vitamins, herbs, and dietary modifications in themanagement of FMS. The emerging FMS literature isshowing promise for many CAM therapies, as no singletherapeutic intervention has been shown to be curative. Thetrend in the clinical management ofFMS syndrome is to treatthe various symptoms of the syndrome using a number ofdifferent interventions, including CAM therapies. This trendfits \\"ell with the traditional chiropractic perspective thathealth and well-being require a "combination approach" toclinical management.

. Journal of Manipulali\'e and Physiological ThcrapeulicsVolume 32. Number 1

METHODS

SearchStrategy

The search strategy for this literature review was focusedon conservative nonphannaceutical treatments for FMS,including chiropractic manipulative therapy. Therefore, oursearch included any conservative therapy that might beincluded within the scope of chiropractic practice, in additionto spinal manipulation. Articles that were opinion pieces,hypotheses, extrapolations from basic science research, andother nonobservational types of articles were excluded fromour revIew.

We used a systematic approach to reviewing the FMSliterature by following this sequence of online searchingstrategies:

.A search of the Cochrane Database of SystematicReviews for systematic reviews and meta-analyses ofrandomized controlled clinical trials (RCTs) for FMS..A search of the National Guidelines Clearinghouse(NGC) for any published guidelines for the manage-ment of FMS..Direct searches of several online databases for addi-

tional RCTs that might not have been included inprevious systematic reviews or meta-analyses. Thesedirect searches included the following databases:PubMed, Cochrane Central Register of ControlledTrials, Allied and Complementary Medicine (AMED),Medline, and Cumulative Index to Nursing and AlliedHealth Literature (CINAHL)..Additional searching of the Manual, Alternative, andNatural Therapy Index System (MANTIS) and Index toChiropractic Literature (lCL) for any additional litera-ture on FMS, including experimental and observationalstudies such as case reports and case series.

The keywords used in our search strategy included theterms fibromyalgia, jibrositis, and jibromyalgia syndromeand covered the literature published in the English languagebetween 1966 and 2006. We did not restrict the searches byusing the term chiropractic, with the exception of one of thesearches within the specific confines of the MANTIS andICL databases. The titles of all retrieved studies were

reviewed for their relevance to chiropractic practice andscope, and the abstracts of any potentially relevant studieswere further reviewed before obtaining full text copies of theentire article. Studies that involved injection, medication,surgery, or other invasive therapies were excluded from ourreview. We did include 2 systematic reviews of theantidepressant medication literature because this class ofmedication is considered an integral component of thestandard medical management of FMS syndrome, albeitoutside the scope of chiropractic practice.

A manual review of the reference lists of the previouslynoted Cochrane systematic reviews and meta-analyses and

Schneider et al

Fibromyalgia Syndrome

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Fig I. Rating scalesfor studies obtainedfrom MANTIS and ICLsearches.

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

I a: Systematic review wilh homogeneity of RCTsIb: Individual RCT with narTOWconfidence interval

2a: Systematic review wilh homogeneity of cohort smdies2b: Individual cohort study or low-quality RCT3a: Systematic review with homogeneity of case-control smdies3b: Individual case-conlrol study

4: Case series. low-qualir;' COh0l1or case-conlrol smdies5:. Expe.1 opinion

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

html)I. ++ = All or most methodological criteria have been fultilled/bias has

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

reduccd.

- = Few or no criteria fi.lfilledlbias is clearly present.

the NGC practice guidelines found that the most recent ofthese publications had searched the FMS Iitera!Ure throughthe year 2002. We therefore performed our own searches foradditional controlled trials using the keywordsjibromyalgiaandfibromyalgia syndrome between the years January 2000and June 2006 on the following databases: MEDLINE,CINAHL, AMED, Cochrane Central Register of ControlledTrials, and PubMed. The rationale for going back to the year2000 was to confinn that we did not miss any relevantstudies and to provide some overlap for comparison with thereferences contained in the search strategies of the previouslyreported FMS systematic reviews, meta-analyses, andpractice guidelines. Our intent was to attempt to find anyadditional clinical trials that were not included in the reviews

performed by the previous meta-analyses and systematicreviews by cross-referencing our list against the list ofreferences from the prior studies.

In addition to searching these standard online databasesfor randomized controlled trials, we specifically wanted tocapture any type of chiropractic literature, includingobservational studies, that might have been published innon indexed journals. Therefore, we specifically performedanother comprehensive search of the MANTIS and ICLdatabases, which are more inclusive of the chiropractic andCAM therapy literature. We used 2 search strategies onthese databases. First, we performed a wide search usingthe terms jibromJ'algia and jibromyalgia syndrome withoutany restrictions to journal type, but restricted the year ofpublication from 1990 to 2006, The rationale for thissearch strategy was simple: 1990 is generally consideredthe inaugural year for fibromyalgia becoming officiallyrecognized as a diagnosis by virtue of publication of theACR criteria for diagnosis of FMS. Our second searchstrategy was to use the keywords jibromyalgia ANDchiropractic for the years of publication from 1950 to

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Fibromyalgia Syndromc

Fig 2. Council on Chiropractic Guidelines and PracticeParameters protocol for grading of recommendations (hllp:!/t'1'1<'.Ccgpp.org).

Grade A: good evidence from relevant studies:

. Studies based on appropriate research designs of sufficient strength toanswer the questions addressed..Results are bolh clinically important and consistent with minorexceptions 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

haw adequate stalistical power.

Grade B: fair evidence from relevant studies:

.. Studies based on appropriate research designs of sufficient strength.bllt with some uncertainty due 10inconsistencies in results. or minordOllbls aboUl gencralizability. bias. design flaws, or sample size..Results from weaker designs. but confirmed in separate studies.

Grade C: limited evidence:.Srudies of appropriate design. but substantial uncertainty due toinconsistencies in results or due. 10 serious doubts about

generaliz<.bilily. bias. research design flaws. or adequacy of samplesize..Results from a limited number of studies or because of weak design

for ans,wring Ihe queMion addressed.

Grade D: expert opinion. and usual and customary praelice: .. Evidence from expert opinion only: research cannot be or has not

been done.

2006. We also used reference tracking to ensure that thesearch was comprehensive.

Evaluation and RatingSystems

As relevant studies were identified, we obtained full textversions of the articles and reviewed them using severalrecognized protocols. The systematic reviews, meta-ana-lyses, and randomized trials were reviewed using the OxfordRating Scale developed by the Centre for Evidence-BasedMedic ine (http://www.library.utoronto.ca/medici ne/ebm)and the appropriate evidence rating checklists developedby the Scottish Intercollegiate Guidelines Network (SIGN)(http://www.sign.ac.uk/methodology/index.html). shown inFigure I. There are separate SIGN checklists for each type ofexperimental and higher-quality observational studies. Theguidelines retrieved from the NGC were evaluated using theappraisal instrument/checklist developed by the Appraisal ofGuidelines for Research and Evaluation (AGREE) Colla-boration (www.agreecollaporation.org).

Finally, after summarizing the literature into evidencetables, we developed some evidence rating tables based uponour interpretation and evaluation of the quality of thisliterature. The evidence rating tables followed a standardfomlat suggested by the Council on Chiropractic Guidelinesand Practice Parameters (CCGPP) (http://\Vww.ccgpp.org) asoutlined in Figure 2.

Journal of Manipulati,'e and Physiological TherapeuticsJanuary 2009

Table I. Systematic reviews. meta-analyses, and practiceguidelines

Type of treatmentaddressed

Systematicliteraturereview

Meta- Practice

analysis guideline Totals

Total

Multidisciplinaryrebabilitation J"

CAM therapiesJ9Exercise20

Pharmacologic vsnonpharmacologic

therapies2!

Nonpharmacologictherapies22

CST23

Mind-body therapies24Massage25

Acupuncture26Antidepressant

medications27.2"FMS treatment and

managemenr9-JJ

8 3 5 16

These references were found upon searching the Cochrane Database of

Systematic Reviews, Database of Abstracts of Reviews of Effects, andAmerican College of Physicians Journal Club (for the years 1996-2006) andthe NGC.

RESULTS

Systematic Reviewsand Meta-Analysesof the FHS literature

Our search of the Cochrane Database of SystematicReviews (1996-2005) using keywords jibromyalgia, fibro-sitis, and jibromyalgia syndrome identified a total of 26ref~rences in this database. After reviewing the abstracts, wefound that only 1I of these studies reviewed conservativetherapies that were directly related to the subject of FMS orwidespread pain. Of relevance to chiropractic practice were 8systematic reviewslg-25and 3 meta-analyses26-n of the FMSliterature. These II references are listed in Table I, alongwith the guidelines we obtained from the NGC. All werefound to be of extremely high scholarly quality_

Of the above-noted 8 relevant systematic reviews of theFMS literature, the one that is most pertinent to chiropracticpractice was published by Holdcraft et al. t9 This systematicreview was further updated and expanded into a clinicalpractice guideline document published by the American PainSociety (APS) a few years later and will be discussed shortly.The Holdcraft et al systematic review of the literaturespecifically assessed the effectiveness of CAM therapies forpeople with FMS. They searched the following onlinedatabases: MEDLINE (1975-2002), BIOSIS Previews(J 975-2002), EMBASE (1990-2002), CINAHL (1982-1998), Alternative Medicine Alert, and the CochraneControlled Trials Register. They reviewed a large numberof studies, encompassing a \vide variety of variousnon pharmacologic therapies including the following: acu-punctme (8 studies including 2 RCTs with 130 patients),

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Journal of ManipuIati\"C and PhY$iologieal TherapeuticsVolume 32. Number I

Schneider ct al

Fibromyalgia Syndrome

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chiropractic (I RCT with 19 patients), magnesium (2crossover RCTs with 39 patients), S-adenosyl-L-methionine(I review of 7 studies including 4 RCTs), chlorella (Icrossover RCT with 37 patients), relaxation (I unblindedRCT with 55 patients), biofeedback (3 RCTs with 274patients), magnet therapies (2 RCTs with 144 patients),homeopathy (I crossover RCT with 30 patients), botanicaloils (J RCT with 30 patients), balneotherapy (J RCT with 48patients), anthocyanidins (I crossover RCTwith 12 patients),and dietary modifications (I RCT with 78 patients).

They concluded that .most of these CAM studies hadseveral methodological limitations: no washout period incrossover RCTs, small sample sizes, lack of blinding,analysis not conducted on an intention-to-treat basis, noappropriate control condition, and lack of an assessment ofthe long-term outcomes. They commented that there wasstrong evidence of the effectiveness of acupuncture, with all8 shldies showing-that acupuncture improved the symptomsof FMS. There was moderate evidence for the effectiveness

of the nutritional supplement S-adenosyl-L-methionine, withlimited but potentially promising evidence for the remainingCAM therapies listed above.

Published Guidelines Found on the NGC

Our search of the NGC database produced a total of 5published guidelines on the management ofFMS.29.33 Threeof the guidelines29-31were rated with the AGREE Instrument

as "re~ommended," and the other 2 guidelines32,33 wererated as "strongly recommended." We found that, of the 2strongly recommended guidelines, the most current (2005)FMS guideline published by the APS33 was very compre-hensive, of excellent quality, and inclusive of mostnonpharmacologic and CAM therapies, including chiroprac-tic. These guidelines will each be reviewed briefly below,with these references listed in Table J along with theprcviously noted systematic reviews and meta-analyses.

One guideline exists regarding FMS and work-relatedinjury, from the Washington State Department of labor andIndustries.29 This guideline states that FMS is not consideredto be an occupational disease based upon their review of thescientific literature that failed to establish a causal relation-

ship between a traumatic injury or occupational exposureand the development of FMS. Under special circumstances,the Department may authorize temporary treatment of FMS;

Note to Table 2

These 44 references were found upon additional scarehes of the MedJine.PubMed. CINAHL. AMED. EMBASE. Database of Abstracts of Reviews

of Effects. and TRIP databases for the years 2000 to 2006. These rcpresentthe FMS literature for individual clinical trials that could potentially have

been omitted from Ihe previously retrieved systematic reviews and practiceguidelines, "ote that a lotal of 20 of these 44 references wcre included in

~le most recent FMS practice guideline'" and systematic review'9 of theFMS literature. "0 additional chiropractic trials were found on any of thesemedical databases.

Table 2. Additional clinical trials

Type of article Duplicates

Articles previouslyreviewed within other

systematic reviews or

Type of treatment Controlled practice guidelinesaddressed clinical trial TOlal (total = 19)-Total 44 44

Chiropr;tctic

Osteopathic

manijmlation'.

Excrclse:\5-4>-: 14 14 Schacter:o vanSanten et al.x

Vitamins and diet 5 5 Hakkinen et al.'o

thcrapy41)..l'Jones et aI.' ,

King et al.J9

Mannerkorpi et ar"AI

I\'ledications,q.o" 6 6 Citera et aLo"

Merchant et al.°'Kanrtinen et aL2

Azad et al,."Edwards et a1.5\

Anderberg et alo.

Body a\\'meness and I I Kendall et al""

qi gongO"

Laser therapy'"

Educationo,o' 2 2

MassageiU.71 2 2

Spa/water therapy 3 ,.\ Buskila et aLbO

(ba Ineotherapy )"0."7.77 Evcik et al07

I\lagnet ther;tpy"" I I Alfano et al"x

Meditation and I I Astin et at". h9

ql gong

Ultrasound andinterferentialcurrent 70

Tai chi7' I I Taggart et al71

Exercise and CBT 2 2(combination

therapy)7,7'

CBT74 I I Soares and Grossi74

Multidisciplinary 2 2

approaches 75.70

30 Schneiderci ;11

Fibromy~lgi::J Syndrome

Table 3. Additional studiesji-om MANTIS and ICL searches

Journal of Manipulative and Physiological TherapeuticsJanuary 2009

Type of tremmenl addressed

TOlal

Chiropraclil' (manipulation and sofl tissue

therapy )>;(u'; I. 11.1. J'50

Os leopal h i~ _man ipu lal ion'~'"'Exercisex.:.l-x!

~S},<)AcupunclUre

Multidisciplinary rehah'H""

Body ,marcness and qi gong ,'~

Brighl light Iherapy""

Therapeulic loueh'"

Craniosacml therapy and muscle c:nergy technique9:-MieroclIlTcnl stimulation"6

Djetarv interventions9i-Qo)

proloti,crnpy""

Homeopalhy"'" "'"

Eye m(H'Cll1cnt uesensitizatilHl1u:,-

Educational programs"'"C13T'fI'

Hair <1naly~js IllSSurface [1\'1G"'"

Thyroid hormone""Waler therapy'"

Chiroprnctic manipuialion and cranial eleClrical slimulation' I~AcupunctUre and diet".1Surccy of CAM thempies used by FMS palicnts refelTed to Mayo clinic"6Psychologic profile of FMS attcnding private chiropractic clinics 117

.

Type of article

Randomized

controlled trial Survey Case-control Case series Case report Total

These 38 referenccs wcre oblained from liternntre searches of the MANTIS and ICL databases from] 950 to 2006. These 2 databases are nol reslricted to

peer-reviewed. indexed journals. Only 3 of thesc sn,dies were included in the most recent'systematic review of the FMS literalUre'9 and FMS practiceguideline" (Blunt et aLxIIDeluze et aL'" and Abrnham and Flechas97). EMG. Electromyography.

but such treatment is limited to physical therapy, low-doseantidepressant and muscle relaxant medication, and spinalmanipulations. Trigger point injections, methotrexate,opioids, and nonsteroidal anti-inflammatory drugs(NSAlDs) are not approved for the treatment of FMS bythe Department.

One FMS clinical Iluideline was found on the NGC Web

site that was published in 2004 by Intracorp,3o a public for-profit organization that had its internal medical technologyand quality assurance committees review the FMS literature.They generated the following recommendations regardingthe clinical management of FMS: recommended-exercise,education, low-dose antidepressants and analgesic medica-tions, heat, and gentle massage; not recommended-steroidsand NSAlDs.

The University of Texas School of Nursing published aguideline31 for the treatment of FMS in 2005 .that suggests astepwise approach as summarized below:

.Educate about prognosis, pathophysiology, and treat-ment principles..Emphasize adequate sleep; treat fatigue and depression..Treat muscle spasm and generalized pain with appro-priate medications.

.Encourage regular exercise, heat, and massage..Address comorbid psychosocial issues.

Another guideline for the management of FMS was

authored by Goldenberg et a]32 and p~ub]ishedin the JAMAin 2004. This guideline was developed by an independentpanel of experts who convened under the sponsorship of theAPS and performed a comprehensive review of the FMSliterature. They produced a consensus document/guidelinebased upon the best available evidence. Their conclusionswere that the FMS diagnosis first must be confirmed and thecondition explained to the patient and family. Any comorbidillness, such as mood disturbances or primary sleepdisturbances, should be identified and treated. Medicationsfor initial consideration are low doses of tricyclic anti-depressants or cyclobenzaprine. Some selective serotoninreuptake inhibitors (SSRls), serotonin-norepinephrine reup-take inhibitors (SNRls), or anticonvulsants may become

first-line FMS me~icatjons as more RCTs are reported. Allpatients with FMS should begin a cardiovascular exerciseprogram. Most patients will benefit from cognitive beha-vioral therapy (CST) or stress reduction with relaxationtraining. A multidisciplinary approach combining each ofthese modalities may be the most beneficial. Other

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I)I

Journal of Manipulali\e and rhy,iolo~ieal Therapeulie,Volume 32. Number I

Table 4. Summaries oj additional studies

Schneider et al

Fibromyalgia Syndrome

31

Clinical trials

Bell el al"ll

Blunt et a I'"

Faull et al" I

l:emstr.\ andOlsvnski')I)

Mannerkorpi andAmdorw')2

Pearl el af"

Senean el alxl,

Wigers et alx;

Wise et alXl

Zijlslra et al91

Title

Improved clinical slatus in fibromyalgia palientsIreated with individualized homeopathic remedies

versus placebo

Effectiveness of chiropractic management of

fibromyalgia palienls: a pilot slUdy

A randomized clinical tri..1of an individualizcd

home-b..sed exercise programme for womenwith fibromyalgia

A pilot study of the comparative effectiveness of IWOwater-based treatments for fihromyalgia syndrome:

Watsu and Aix massage

Treatmern offibromyalgia syndrome with

fonnula acupuncture

Effectiveness of multidisciplinary rehabililation inthe treatment of fibromyalgi'l: a mndomizedcontrolled trial

Effic..cy and feasibility of a combin"lion of body..wareness therapy and qigong in patients with

fibromyalgi..: a pilot slUdy

The effects of bright light treatment on the symptomsof ftbromyalgia

A smdy to compare the thempeUlie efficacy of aerobicexercise and paroxetine in fibromyalgia syndrome

Effects of aerobic exercise versus slress management

trealment in fibromyalgia: a 4.5 year prospective study

Effecliveness of chiropractic treatment on fibromyalgia

syndrome: a randomized controlled trial

Spa treatment for primary fibromyalgia syndrome: a

combination of thalassolherapy. exercise andpalient education improves symptoms and qualilyof life

Summary

N = 62; RCT comparing oral homeopalhic remedy with

indistinguishable placebo; only 53 completed the trial;

equivocal finding that homeopathic treatment was bener

than placebo

N = 19; preliminary RCT with spinal manip. stretching.soft tissue Iherapy; positive outcome for intcrventions bul

no control group and small sample size make findings

equivocal

N = 79; RCT compared moderate-inlensity home exercises

10 usual care control group; home-based exercises beneroutcome than conlrol

Nonrandomized clinical trial; n = 13Watsudid Deiterthan Aix,bUIno control group andsmall samplesize makefindingsequivocal

Single-blind RCT: n = 114 comparing 4 types of

acupuncture traditional/nontraditional needle placemenlwith/without electrical stimulalion: no control group; all 4

types were effective

N = 79 comparedstandardmedical care with a combo ofgroup exercise. stress management. massage therapy. andeducation. Positive OUlcomefor inlervention vs standardcare.

N = 36: RCTcomparedqigongplus body awareness10acontrol group: no difference belween groups on changes in

pain/limction

N = 14; RCT crossover trial compared bright light therapyto a "fillered" light Iherapy. No significant difference

between groups. Very small sample size and no controlgroup make findings equivocal

N = 60; RCTcomparing3 groups; AE on a bike,paroxeline. placebo TENS: AE group had less analgesicuse. AE and paroxetine groups had bener outcomes Ihan

the placebo TENS grO\lp.

N = 60; RCT comparing 14 wk of treatment wilh AE. SM.or treatment as usual: AE and SM had positive short-Ienn

effects. AE was overall most effective trealment, no long-

tenn benefits /Tom any group

Published in WFC 7th biennial congress conference

proceedings. scant description of study and results. Wait.lisl control group.

N = 136; RCT compared 2 1/2 weeks of treatment at a sparesort with treatment as usual: spa thempy reduced pain al3 mo. but not at 6 or 12 mo

SIGN/Oxford

rating

1+/2b

1+/2b

2+/1 b

2+/2b

2+/1 b

2+/lb

1+/2b

1+/2b

2+/1 b

2+/lb

1-/2b

2+/1 b

(conlillued Oil nexI page)

32 Sehneider et al

Fibromyalgia Syndrome

Table 4. (contillued)

Journal of Manipulath'e and Physiological ThcrapculicsJanuary 2009

Clinical Irials

Case reports andior case series

Abraham andFlechas 9i

r riedberg ,no

Gemmell et al")4

Hains andHains II.

Henrikssonet alln()

Leach and

Hosek to"

Lukaczer et a19"

McMakin et aJ''''

Michalsen et al""

Silva el al"o

Slotz and

Kappler"'

Tyers andSmith"2

Wise andWalsh110

Title

Title

Management of fibromyalgia: rationale for the use of

mngnesium and malic acid

Touch the pain away: new research on IherapeulictOuch and persons with fibromyalgia syndrome

Eye movement desensitization in fibromyalgia

Homeopathic Rhus Toxicondendron in the treatment offibromyalgia

Combined ischemic compression and spinal manipulationin the treatment of fibromyalgia: a preliminary estimateof dose and efficacy

Clinical fomm: fibromyalgia syndrome

Evaluation of four outpatient educational programmesfor patients with longstanding fibromyalgia

Clinical and myoeleclric observations on fibromyalgia:

a prospective descriptive clinical series

Osteopathic manipulative treatment in fibromyalgia

syndrome

A pilot trial evaluating Meta050. a proprietarycombination of reduced iso-alpha acids. rosemaryextract and olem\olic acid in patients wilharthritis and libromyalgia .

Cytokine changes with microcurrent ([ealmenlof fihromyalgia associated with cervical spine trauma

Meditemmean diet or extended fasting's inOuenceon changing Ihe intestinal microOora. immunoglobulin/I. secretion and clinical outcome in patients withrheumatoid arthritis and fibromyalgia: anobservational study

/I. retrospective review of outcomes of fibromyalgiapatients following physical therapy treatments

The effects of osteopathic manipulative treatment onthe tender points associated with fibromyalgia

A comparison of cranial electrotherapy stimulation

alone or with chiropractic therapies in the treatmentof fihromyalgia

Chiropractic treatment of fibromyalgia: Iwo case studies

Summary

Summary

N = 15 case series of patients

Case series: no specific no. of subjects reported

N = 6 patients who had 2 treatment sessions

N = 3 case series of patients: no significant effects found

N = 15 case series of patients given 30 chiropractic

treatments, most patients had a favorable response tointervention

Single-case report

N = 191: survey data comparing 4 educational programs

varying in total length of time and no. of slaff/patientcontact hours. No differences between groups.

Published in Proceedings of the International Conference on

Spinal Manipulation; no specific description of researchdesign

N = 19 patients treated with OMT; most had a favorableoutcome with intervention

N = 54 patients with "rheumalic disease"; osteoarthritis,RA. and/or FMS

N = 54 consecutive patients

N ~ 5 I consecutivc patienls: 16 RA patients and 35 FMS

patients

N =23 charts analyzed ITom a physical therapy clinic that

used Up1edger craniosacral therapy and muscle energytechniques

N = 18: case series of patients

Case series with no specific number of patients cited

N = 2 case reports

SIGN/Oxfordrating

1+/3b

1-/3b

1+l3b

J+/3b

1+/3b

1-/4

2+/2b

1-/3b

1+/3b

1+/3b

l+l3b

)-.t./3b

1+/3b

1+/3b

1-/3b

1+/4

Journal of Manipulalive and Physiological TherapeuticsVolume 32. Number I

Table 4. (continued)

Schneider et al

Fihromyalgia Syndrome

33

Clinical trials Title

Survey research Title

Jamison 117 A psychologic profile of fibromyalgia patients:a chiropractic Case sntdy

Wahner.Roedler

et al"oCse of eomplemcntary and altemat!ve medical therapiesby patients referred to a fibromyalgia trealment

programat a tertiarycarecenter

Case.control

study

Title

Hair calcium and magnesium levels in patients with

fibromyalgia: a Case center study

Summary

Summary

SIGN/Oxford

rating

Survey forms given to FMS patients. maintenance 2+/2b

chiropractic patients, and Ihe DCs lreating them at 5 scparatechiropractic clinics in Australia: >50% of FMS weredistressed and only 14% of maintenance patients.

N = 289 patients at the Mayo clinic FMS treatment progmm 2+/2bwere given survey fomls to complete. 98% had used some

fonn of CAM therapy, as follows: 48% used exercise. 45%used prayer or spirintal healing, 44% used massage therapy.37% had used chiropractic, about 25% used various vitamintherapies and dietary changes.

Summary

N =24: 12patientswho had hair analysisperformedand mel 1.!3bthe ACR criteria for FMS were age-/sex-matched with 12healthy control patients who had hair analysis perfonned for

general screening purposes; significantly higher amounts ofcalcium and magnesium in FMS group

N = 121: 79 FMS patients completed a JO-wk stress 2+/2breduction. cognitive behavioral meditation program. Control

group was 42 FMS patients on wait list. CBT group showedsuperior outcomes to controls.

Expanded summaries of results of litcrantre search on MANTIS and ICL databases using the keywords fibromya/gia (1990-2006) andjibmlllya/gia IINDchiropraclic (1950-2006). The explanation of SIGN/Oxford rating protocol is in Figure I. AE. Aerobic exercise: TENS. transcutaneous electrical nervestimulation: SM, stress management: WFC. World Federation ofChiropraclic: OMT, osteopathic manipulative treatment: RA. rheumatoid anhritis.

Goldenber~et ailin ...

A controlled sntdy of a stress-reduclion,

cognitive-behavioral treatment program in fibromyalgia.

medicati.ons, such as tramad.ol .or c.ombinati.ons .of medica-. ti.ons, sh.ould be c.onsidered. Patients with FMS n.otresp.onding well t.o these steps sh.ould be referred t.o arheumat.ol.ogist. physiatrist, psychiatrist, .orpain managementspecialist.

The m.ost current .ofall the FMS guidelines identified by.oUTsearch (as .of June 2006) was auth.ored by Buckhardtet al33 and published by the APS in 2005. We f.ound thisguideline t.o be very c.omprehensive, well written, andapplicable t.oa wide variety .ofdifferent clinicians, includingthe chir.opractic pr.ofessi.on.It basically .offers rec.ommenda-ti.ons f.or the management .of FMS acc.ording t.o the 3 m.oststrongly evidence-based therapies described in m.ost .of theC.ochrane systematic reviews, that is, l.ow-d.oseantidepres-sant medicati.ons, aerobic exercise, and CBT.

The 2005 APS guideline further suggests that physicianssh.ould c.onsider the .opti.on .of having their patients try.other c.omplementary treatments such as acupuncture,bi.ofeedback, chir.opractic manipulati.on, hypn.osis, andmassage. They cauti.oned against the use .of the f.oll.owingprocedures far which there is n.o evidence .of therapeuticefficacy in the treatment .of FMS: .opi.oids, c.ortic.osteroids,n.onster.oidal anti-inflammat.ories, benz.odiazepines, and ten-der .or trigger p.oint injecti.ons.

The m.ost imp.ortant c.onclusi.ons and rec.ommendati.onsfrom the 2P05 APS guideline f.orFMS are summarized bel.ow.

I. Rec.ommend tricyclics, SSRls, anxi.olytics, and painmedicati.ons f.orimproving sleep, reducing anxiety/dep-ressi.on, and decreasing pain. N.onster.oidalanti-inflam-matory drugs and c.ortic.osteroidsare n.otrec.ommended asprimary medicati.onsf.orthe treatment .ofFMS.

2. Use CBT t.oreduce pain and psych.ol.ogicdisability byenhancing self-efficacy, self-management, and skillsf.or c.opingwith pain.

3. Use aer.obicexercise t.ominimizepain, impr.ovesleep qua-lity, enhance self-efficacy,and increase p.ositivem.o.od.

4. Offer clinician-assisted treatments such as clinical

hypn.osis and bi.ofeedback, acupuncture, chir.opracticmanipulati.on, therapeutic massage, and balne.otherapy,which maybe helpful f.orpain relief.

5. Use multidisciplinary approaches that inc.orp.orate2 .orm.ore strategies t.odecrease pain and impr.ove functi.onin FMS, especially in pe.oplewh.o have n.ot resp.ondedt.o simpler appr.oaches.

6. Emphasize sleep hygiene as part .of the treatment plan,using b.oth phamlac.ol.ogic and n.onphamlac.ol.ogictechniques.

34 Schneider el al

Fibromyalgja Syndrome

Journal of Manipulatiye and Physiological TherapeuticsJanuary 2009

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

Topic Conclusion and strength of evidencerating

FMS

Evaluation Rating A: pressure algometry

There is slrong evidence that pressure algometry has high reliability and validity in the assessment of the TePs foundin FMS. .

Rating A: FIQThe FlQ has achieved wide recognition as a reliable and valid inslrument as pan of FMS management and research,

and has been translatcd into se"cral languages.

Rating B: massage. There is moderate evidence from sevcral RCTs and I systema(jc review that massage is helpful

in improving sleep and reducing anxiety in chronic pain.Raling C: manipulation. There is limitcd evidencc consisting of I small chiropractic pilot RCT that manipulation

may relieve pain in FMS. The literature also contains 2 chiropractic and 2 osteopathic manipulation case repons!series.

Manual therapies

Rating A: aerobic exercise. There is strong evidence from multiple RCTslsystematic reviews that mild aerobiccxereise is helpful in relieving the pain and fatigue associated with FMS.

Rating B: muscle strength training. There is moderate evidence that mild strength training programs are helpful inFJ\'IS: hOll"cyer. the evidence does not suppon moderate or heavy intensity strength training for FMS patients.

Rating C: mOYement and body awareness. There is preliminary evidence from 3 small RCTs that gentle bodyawareness exercise methods such as tai chi and qi gong arc helpful with FMS.

Exercise

Vitamins. herbs. diet modificmion Rating C: ,'itamins. herbs. diet rnodilic,nion. There are several small RCTs with preliminary evidence showing apotential beneficial elfect of these therapies for FMS.

CBT Rating A: CBT. There are several large RCTs and systematic reviews showing a strong treatment effect of CBTalone. and in combination with exercise and various medicmions. for the clinical management of FMS symptoms.

Medications 0 Rating A: The medications with the strongest evidence of effectiveness (multiple systematic reviews and RCTs) for

FMS :tre amitriptyline and cyclobenzaprine used alone or in combination with SSRls or SNRls. Emerging evidenceis for pregabalin. gabapentin. and tramado I. No evidence for NSAIDs or eonicosteroids used alone.

Balneotherapy (spa therapy) Rating B: balneotherapy. There is moderate evidence ITom several consistent RCTs showing reduction of FMSsymptoms with hot water/spa treatments.

Rating B: acupuncture. 'fhere is I systematic review and I additional RCT that show moderate reduction of pain inFMS paticnts with acupuncture treatment.

FIQ. Fibromyalgia Impact Questionnaire.

" Although prescription medications and acupuncture are outside the scope of chiropractic practice in many jurisdictions. we have included them in theevidence tables because of their popu lar and widespread use among FMS patients. .

Acupuncture"

7. Treat anxiety and depression aggressively with bothphannacologic and nonpham1acologic approaches.

We rated the 2005 APS guideline as the highest-qualityguideline we reviewed using the AGREE Instrumentand considered it to be the most complete and comprehen-sive guideline for the clinical management of FMS that wascUITentlyavailable at the conclusion of our literature searchin June 2006. We highly recommend that the serious readerof the FMS literature obtain a copy of this guideline. Mostof our summary ratings agree with the ratings found withinthis guideline,

AdditionalSearchesfor FHSControlledClinicalTrialsOur search for additional randomized controlled trials on

the MEDLlNE, CINAHL, AMED, Cochrane CentralRegister of Controlled Trials, and PubMed databases yielded

a total of 44 studies,34-77 of which 25 were found to berelevant and not previously included in prior systematicreviews or meta-analyses. The other 19 studies werepreviously considered within the context of at 'Ieast one ormore of the systematic reviews listed in Table I. These 44references are summarized in Table 2. Of these 44 studies,

the largest number of RCTs (n = 14) was of various exerciseinterventions for FMS symptoms, 7 of which were includedin prior systematic reviews. Because exercise is already anestablished treatment of FMS, these additional 7 exercisestudies do not change any recommendations from thepreviously noted systematic reviews. There were noadditional clinical trials pertaining to chiropractic treatmentor management of FMS. We retrieved 5 trials on vitaminsand on nutritional and dietary interventions: however, all ofthese studies were included in previous systematic reviewsand practice guidelines. A total of 19 studies of the 44references (Table 2) found during our search were previously

Journal of Manipulali\'~ and Physiologi~al Th~rap~uti~sVolum~ 32. Number'

included in the reference sections of prior systematic reviews. or practice guidelines and therefore were consideredredundant.

The 25 studies that we found that were not previouslyconsidered in any of the prior systematic reviews or practiceguidelines are listed in Table 2. We used the Oxford RatingScale 78,79as well as the SIGN Checklist, as summarized inFigure I, to rate the quality of these clinical trials. Theadditional studies that have the most potential relevance tochiropractic practice, which are of reasonably good scientificqualify, are the following (SIGN/Oxford ratings are pre-sented in parentheses): osteopathic manipulation (I smallpilot RCT [J+/2b]), massage therapy (2 small RCTs [2+/2b]), laser therapy (I small RCT [I +/2b]), spa water therapy!balneotherapy (I moderate-sized RCT [(J+/lb]), and ultra-sound and interferential current (I small RCT [J+/2p]).

The results of our search for clinical trials from 2000 to

2006 basically confinl1 the previously summarized findingsand conclusions of the Cochrane systematic reviews andmeta-analyses ofFMS literature, as well as the most recentlypublished practice guidelines on the clinical management ofFMS. We concluded that the 25 additional studies we found

and rated would not substantially alter any of therecommendatiqns made in any of the. current publishedFMS practice guidelines, systematic reviews, or meta-analyses.

Search of the MANTISand ICL Databases

Our combination of 2 search strategies of the MANTISand ICL databases from] 990 to 2006 produced a total o£10 Icitations, most of which were found to be opinion papers,hypotheses, anecdotal reports, and other types of narrativepublication. Thirty-eight studies did meet our liberalinclusion criteria of being at minimum a single-case report,case series, or other type of acceptable observational study.We accepted any published observational study, r~gardlcs5of whether it was published in a peer- or non-peer-reviewedjournal.

A total of 38 articles80-117 were selected from the

MANTIS and ICL databases using the keywords jibro-

myalgia and jihromyalgia AND chiropractic. These 38articles are summarized in Table 3 and consisi of the

following types of studies: 17 clinical trials, J7 case reportsand/or case studies, 2 case-control studies, and 2 survey-typestudies.

Reference tracking was used to look for potential overlapof references from the MANTIS and ICL searches. Three ofthe studies found from our MANTIS and ICL searches were

included in the most recent systematic reviewl9 of the FMSliterature and FMS practice guideline33 (Blunt et ai,xoDeluze et al,88 and Abraham and Flechas97). Therefore, 35articles 'were found that represented unique and separatecontributions to the FMS literature. Expanded summaries ofall these studies are listed in Table 4, along with their

Schneider eJ al

fibromyalgia Syndrome

35

respective Oxford/SIGN ratings. Regarding chiropractictreatment of FMS, we found J additional RCT,81 I case-series report,1I5 and ] single-case report.114 The RCTdescribing chiropractic treatment of FMS was published inthe World Federation of Chiropractic seventh biennialcongress conference proceedings,81 which consisted of avery scant description of the study and results. A hand searchfor a detailed full text peer-reviewed version of this studywas attempted, but we could not find any full text peer-reviewed publication of this study.

DISCUSSION

A consistent theme emerges trom all of the systematicreviews; meta-analyses, and practice guidelines that wereviewed: there is no known cause or etiologic agent(s)responsible for the development of the symptom complexknown as FMS. All treatment options are merely directedtoward amelioration of the major symptoms of widespreadpain and fatigue, and are not expected to cure the condition.Most systematic reviews have concluded tbat 3 basictherapies have the strongest and most established evidencebase with respect to treatment of FMS:

I. Cognitive behavioral therapy and other relaxationmethods.

2. Mild aerobic and general flexibility exercises.3. Various low-dose antidepressant medications (tricyc-

lics and SNRls), with emerging evidence for antic-onvulsants (gabapentin, pregabalin) and tramadol.

It is interesting to note tha.t 2 of the 3 published meta-analyses were on the subject of antidepressant medications,which are not directly applicable to chiropractic practice. Atfirst glance, this seems to contradict our search strategy tofocus on nonpharmacologic FMS therapies. However, wedecided to include these 2 medication meta-analyses in ourreview because the use of low-dose antidepressant medica-tions is considered by all major guidelines to be ] of the 3most evidence-based treatments for FMS (see bullets above).Therefore, we thought it important to include these studiesfor completeness and to provide a brief synthesis of thisliterature for the reader's convenience.

We found that the 2005 APS guideline33 provided themost comprehensive review of the literature and bestevidence synthesis to date, which was inclusive of all thepertinent chiropractic and CAM literature. We stronglyrecommend that clinicians consult this guideline for the mostcurrent evidence synthesis and best practices documentregarding the clinical management of FMS. After carefulreview of the additional studies we retrieved from searchesof several standard databases, as well as MANTIS and ICL,we could not find any compelling new evidence that wouldsubstantially alter the recommendations presented in the

36 Schneider e! al

Fibromyalgia Syndrome

most current systematic reviews, meta-analyses,. and practiceguidelines.

Although we formally concluded our search of the FMSliterature in June 2006, we did review the recently publishedguidelines by the European League Against Rheumatism(EULAR) in 2007 that gave evidence tables for themanagement of FMS. lIS The 2007 EULAR guidelinesessentially recommend the same medications as those in the2005 APS guidelines, with the addition of strong evidencefor SNRIs, tramadol, gabapentin, and pregabalin. All ofthese medications were given the highest evidence raling bythe EULAR panel. It is interesting to note the ratings of thenonpham1aceutical treatments recommended: medium evi-dence for heated pool treatments (balneotherapy), weakevidence for aerobic and strength exercises, weak evidencefor relaxation and psychologic support, and poor evidencefor CST. These nonpharmaceutical ratings are somewhatcontradictory to the APS ratings and evidence tables. TheEULAR guidelines did not specifically provide any ratingfor spinal manipulation or chiropractic care.

It was very surprising to find such a paucity ofchiropractic literature about the clinical management ofFMS, considering that chiropractors frequently report thatthey treat FMS patients. We were only able to find 4 relevantchiropractic clinical studies regarding FMS treatment in theMANTIS and ICL databases, for a total of 2 small clinicaltrials,SO,81I case series, 114and I single-case report. II~Onlyone of these chiropractic trials was of sufficient quality to beincluded in the APS guideline.8o The other chiropractic

.trialSI was published only in the form of an expandedabstract as preliminary findings in conference proceedings,and we could not find any full text version of these findingsin the peer-reviewed or non-peer-reviewed literature.

The National Board of Chiropractic Examiners hasgathered data about chiropractic practice in the UnitedStates through surveys performed in 199I, 1998, and 2003.The results have been collectively published in a series of :3texts known as the Job Analysis 0/ Chiropractic, with themost recent version published in 2005.119 The 2005 JobAnalysis of Chiropractic data revealed that 4 soft tissueconditions are reported by clinicians as "often" or "some-times" seen in chiropractic practice: muscular strain/tear,tendinitis/tenosynovitis, myofascitis, and FMS.

Chiropractors report that they treat the first 3 conditionslisted 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 thesecases. However, in the case ofFMS, chiropractors report thatthey only see this condition "sometimes" and choose to co-manage this condition with another health care provider inabout 55% to 64% of cases. These findings suggest thatchiropractors feel very confident in their ability to managemuscle and tendon conditions, but much less confident inmanaging FMS by themselves as noted by the high rate ofmedical co-management

Journal of Manipulative and Physiological TherapeuticsJanuary 2009

The results of our literature synthesis were compiled intoa summary of recommendations for the most evidence-based procedures for the clinical management of FMS aspresented in Table 5. It is important to note that many ofthe therapies listed in our evidence ratings table are withinthe scope of chiropractic practice and sho'v at least goodto fair levels of evidence. However, the standard medicalmanagement of FMS still relies heavily on prescriptionmedications, which are clearly outside the chiropractic scopeof practice.

Yet the other 2 most evidence-based treatments for FMS,

exercise and CST, could be incorporated in most chiropracticpractices. This requires an understanding of the importanceof central sensitization as the key mechanism underlying thewidespread allodynia found in FMS, and that patients needan active care approach to treatment that will incorporateboth a mild exercise program with an empathetic bedsidemanner in which the chiropractor provides education,positive emotional support, and possible refeiTaI for groupor individual psychologic counseling.

There is certainly a trend within the FMS literature toexpand treatment and research efforts outside of the!raditional allopathic model to include a number of CAMtherapies that are within the scope of chiropractic praCtice. Itwould be desirable to see more chiropractic interest indeveloping high-quality experimental and observationalresearch into this area. There is a great potential for futurecollaboration between chiropractic researchers and otherprofessions to develop multidisciplinary approaches to theclinical management of FMS that involve CAM therapiesunder the umbrella of chiropractic care.

CONCLUSIONS

Most systematic reviews and guidelines all recommend 3interventions as having the strongest evidence support: (])low-dose antidepressant medications, (2) light aerobicexercise, and (3) CST. Moderate evidence supports the useof massage, muscle strength training, acupuncture, and spatherapy (balneotherapy). Limited evidence supports spinalmanipulation; movementlbody awareness: and vitamins,herbs, and dietary modifications. Presently, there is nosingle therapy or intervention that can be considered a curefor FMS. Combinations of therapies appear to be mosthelpful, and future research seems to be looking towardstrategies by which to find subgroups of FMS patients whomight respond better to certain therapj~s. Our project stoppedsearching the literature as of June 2006, and newer evidencehas surfaced since that time. The most recent studies wouldinclude the EULAR evidence-based recommendations for

the management of FMS!IX and a recently publishednaiTative review of the mechanisms and pathophysiologyof fibromyalgia. 120These publications continue to provideevidence that FMS is not a peripheral disorder of the soft

Journal or Manipulative and Physiological TherapeuticsVolume 32, Number I

tissues, but rather a disorder of aberrant pain processing and<;:entralsensitization.

]n conclusion, we found that there is an emergingliterature regarding a number of CAM therapies for theconservative treatment of FMS syndrome, including spinalmanipulation. There is a dearth of experimental chiropracticliterature on the management of soft tissue conditions andFMS. It is recommended that the chiropractic researchcommunity take notice of this infomlation gap and take stepsto design high-quality experimental research studies to helpclose this information gap. Such research by the chiropracticprofession could be an excellent opportunity to build bridgesand collaborate with other health care professions and thescientific community.

Practical Applications

.Strong evidence supports aerobic exercise andcognitive behavioral therapy.

. Moderate evidence supports massage,strength training, acupuncture, and spa(balneotherapy).

. Limited evidence supportsmovement/body awareness:and dietary modification.

muscle

therapy

spinal manipulation:and vitamins, herbs,

ACKNOWLEDGMENT

The primary author and all coauthors are members of thesoft tissue committee of the CCGPP commissioned to do this

comprehensive review. None of the authors has received anyfinancial support from the CCGPP for this study, and nocompeting financial interests are declared. The authors thankTom Hyde who assisted us with review of full textmanuscripts.

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Regional cerebral blood flow in fibromyalgia: single-photon-emission computed tomography evidence of reduction in thepontine tegmentum and thalami. Arthritis Rheum 2000;43:2&23-33.

14. Russell I. editor. MYOPAIN '95: abstracts from the 3rd World

Congress on myofascial pain and fibromyalgia. Binghamton,NY: lIaworth Press Inc.: ]995. p. 6-92.

15. Vecchiet L. Giamberardino A. editors. Muscle pain, myofas-cial pain. and fibromyalgia: recent advances. Binghamton.NY: lIa\\orth Press. Inc.: 1999. p. 3-98.

16. Schneider M1. Brady D. Fibromyalgia syndrome: a newparadigm for differential diagnosis and treatment. 1 Manip-ulative Physiol Ther 200 1:24:529-39.

] 7. Schneider MJ. Brady D. Perle S. Commentary: differentialdiagnosis of fibromyalgia syndrome. 1 Manipulative PhysiolTher 2006:29:493-50 I. .'

18. Karjalainen K. Mahnivaara A. van Tulder M. et al. Multi-disciplinary rehabilitation for fibromyalgia and musculo-skeletal pain in working age adults. Cochrane Database SystRev 2000:CDOO1984.

19. Holdcrafi LC. Assefi N, Buchwald D. Complementary andalternative medicine in fibromyalgia and related syndromes.Best Pract Res Clin Rheumatol 2003; J7:667-83.

20. Busch A, Schachter C. Peloso P, Bombardier C. Exercise fortreating fibromyalgia syndrome. Cochrane Database Syst Rev2007:CD003786.

21. Beman BM_"Ezzo 1. Hadhazy Y, Swyers 1. Is acupunctureeffective in the treatment of fibromyalgia? 1 Fam Pract 1999;48:213-8.

22. Sim 1. Adams N. Systematic review ofrandomized controlledtrials of non-pharTl1acological interventions for fibromyalgia.Clin J Pain 2002; 18:324-36.

23. Nezu AM. Maguth Nezu C. Lombardo E. Cognitive-behavior therapy for medically unexplained symptoms: acritical review bf the treatment literature. Behav Ther 2001;32:537-83.

24. Hadhazy V, Ezzo J. Creamer P, BerTl1an B. Mimi-bodytherapies for the treatment of fibromyalgia: a systematicreview. J Rheumatol 2000:27:2911-8.

25. Richards KC Gibson R. Overton-McCoy A. Effects ofmassage in acute and critical care. AACN Clin Issues 2000;11:77-96.

Journal of Manipulati\'e and Physiological ThcrapclIticsVolume 32, Number I

tissues, but rather a disorder of aberrant pain processing andcentral sensitization.

In conclusion, we found that there is an emergingliterature regarding a number of CAM therapies for theconservative treatment of FMS syndrome, including spinalmanipulation. There is a dearth of experimental chiropracticliterature on the management of soft tissue conditions andFMS. It is recommended that the chiropractic researchcommunity take notice of this information gap and take stepsto design high-quality experimental research studies to helpclose this information gap. Such research by the chiropracticprofession could be an excellent opportunity to build bridgesand collaborate with other health care professions and thescientific community.

Practical Applications

. Strong evidence supports aerobic exercise andcognitive behavioral therapy.

. Moderate evidence supports massage,strength training, acupuncture, and spa(balneotherapy)..Limited evidence suppottsmovementlbody awareness:and dietary modification.

muscle

therapy

spinal manipulation:and vitamins, herbs,

ACKNOWLEDGMENT

The primary author and all coauthors are members of thesoft tissue committee of the CCGPP commissioned to do this

comprehensive review. None of the authors has received anyfinancial support from the CCGPP for this study, and nocompeting financial interests are declared. The authors thankTom Hyde who assisted us with review of full textmanuscripts.

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