effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a...

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Journal of Bodywork & Movement Therapies (2014) xx, 1e22

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Effectiveness of body awarenessinterventions in fibromyalgia and chronicfatigue syndrome: A systematic review andmeta-analysis

Imke Courtois, MSc, PT a, Filip Cools, PhD, MD b,Joeri Calsius, PhD, D.O., PT a,*,1,2

a Reval Research Center, University Hasselt, Faculty Medicine and Life Science, Belgiumb Belgian Center for Evidence-Based Medicine, Belgian Branch of the Dutch Cochrane Center(CEBAM), Belgium

Received 15 October 2013; received in revised form 20 February 2014; accepted 3 March 2014

KEYWORDSBody awareness;Body-orientedapproaches;Chronic fatiguesyndrome;Fibromyalgia;Hands-off;Hands-on

* Corresponding author. Universitei476545128.

E-mail addresses: imke.courtois@u

1 www.uhasselt.be.

2 Onderzoeksgroep Reval, Agoralaan

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http://dx.doi.org/10.1016/j.jbmt.2011360-8592/ª 2014 Elsevier Ltd. All rig

Summary Objectives: Patients with long-lasting pain problems often complain of lack ofconfidence and trust in their body. Through physical experiences and reflections they candevelop a more positive body- and self-experience. Body awareness has been suggested asan approach for treating patients with chronic pain and other psychosomatic conditions. Theaim of this systematic review is to assess the effectiveness of body awareness interventions(BAI) in fibromyalgia (FM) and chronic fatigue syndrome (CFS).Methods: Two independent readers conducted a search on Medline, Cochrane Central, PsycIN-FO, Web of knowledge, PEDro and Cinahl for randomized controlled trials.Results: We identified and screened 7.107 records of which 29 articles met the inclusioncriteria. Overall, there is evidence that BAI has positive effects on the Fibromyalgia ImpactQuestionnaire (FIQ) (MD �5.55; CI �8.71 to �2.40), pain (SMD �0.39, CI �0.75 to �0.02),depression (SMD �0.23, CI �0.39 to �0.06), anxiety (SMD �0.23, CI �0.44 to �0.02) andHealth Related Quality of Life (HRQoL) (SMD 0.62, CI 0.35e0.90) when compared with controlconditions. The overall heterogeneity is very strong for FIQ (I2 92%) and pain (I2 97%), whichcannot be explained by differences in control condition or type of BAI (hands-on/hands-

t Hasselt, Campus Diepenbeek, Agoralaan Gebouw D, B-3590 Diepenbeek, Belgium. Tel.: þ32

hasselt.be (I. Courtois), [email protected] (F. Cools), [email protected] (J. Calsius).

Gebouw A, 3590 Diepenbeek, Belgium.

urtois, I., et al., Effectiveness of body awareness interventions in fibromyalgia and chronic fatiguemeta-analysis, Journal of Bodywork & Movement Therapies (2014), http://dx.doi.org/10.1016/

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2 I. Courtois et al.

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off). The overall heterogeneity for anxiety, depression and HRQoL ranges from low to moder-ate (I2 0%e37%).Conclusions: Body awareness seems to play an important role in anxiety, depression andHRQoL. Still, interpretations have to be done carefully since the lack of high quality studies.ª 2014 Elsevier Ltd. All rights reserved.

Table 1 Criteria for FM and CFS.

Fibromyalgia According to ACR criteria 1990 [6]:History of widespread pain for at least3 months in combination with pain in 11of 18 tender point sites on digitalpalpation.According to revised diagnostic

criteria [7]:Meeting 3 conditions;

1) Widespread pain index (WPI) � 7and symptom severity (SS) scalescore � 5 or WPI 3-6 and SS scale

score � 9.2) Symptoms have been present at

similar level for at least 3 months.3) The patient does not have a disorder

that would otherwise explain the pain.Chronic Fatigue

SyndromeAccording to CDC criteria [8]: Medicallyunexplained, persistent fatigue, of newonset, not due to ongoing exertion, notsubstantially relieved by rest, andsignificantly reducing previous activitylevels.Four-or-more additional symptoms, forat least 6 months, among which are:

- Multiple muscle/joint pains- Concentration/memory disturbances- Non-refreshing sleep- Headache (new onset)- Sore throat- Tender lymph nodes- Post-exertional malaise

Introduction

Medically unexplained symptoms, fibromyalgia andchronic fatigue syndrome

Medically unexplained symptoms (MUS) are somatic symp-toms that cannot be (adequately) explained by organicfindings or where no clear organic etiology can be identifiedafter an appropriate medical examination. Fibromyalgia(FM), irritable bowel syndrome (IBS), Chronic Fatigue Syn-drome (CFS) and non-cardiac chest pain are all examples ofclusters of symptoms, which belong under the broad um-brella of MUS. Approximately one third (30e50%) of in-dividuals who visits the general practitioner is diagnosedwith MUS (Buffington, 2009; Landelijke Stuurgroep Mul,2010). Most complaints disappear after a few days toweeks. In 20e30% of the cases, these complaints remain fora longer period (Landelijke Stuurgroep Mul, 2010). Besidesthe high prevalence in health care, they are also respon-sible for a significant proportion of disability in workforce(Henningsen et al., 2003). Moreover, these individualsusually have merged symptoms making them even morerestricted in their daily functioning and causing an evenlonger period of symptoms or complaints (LandelijkeStuurgroep Mul, 2010). These patients usually presentwith back pain, headache, chest pain, fatigue, pain in armsand legs, gastro-intestinal symptoms, joint pain and dizzi-ness (Van Dieren and Vingerhoets, 2007). Bodily sensationsare often hyper-present, difficult to express in words,meaningless and mentally unprocessed, fitting the conceptof what Verhaeghe calls actualpathology (Verhaeghe andVanheule, 2005; Verhaeghe, 2011). The inability to ex-press inner experiences in words (i.e. alexithymia) andconsequently the lack of mental processing (i.e. mentali-zation) are both crucial factors in MUS (Verhaeghe andVanheule, 2005). Arousal derived from within the body(i.e. proprioception and interoception) cannot be pro-cessed (enough) by mental representations or construc-tions, leading to a more ‘body-oriented’ coping strategy.Symptoms represent this strategy and are attempts tohandle the arousal coming from inside the body. Com-monalities across the different MUS include over-representation of females and individuals who had to dealwith negative experiences in the past (Van Houdenhove andet al., 2001). Although it may have an insidious onset,symptoms usually occur suddenly (after a precipitatingevent) and have a variable course (Buffington, 2009).

Fibromyalgia (FM) and Chronic Fatigue Syndrome (CFS)are both part of a broad category of ‘functional somaticsymptoms’ or MUS. In psychiatric diagnosis they were pre-viously referred to as ‘undifferentiated somatoform disor-der’ but are recently e in DSM-V e redefined as ‘somatic

urtois, I., et al., Effectiveness ofmeta-analysis, Journal of Body

symptom disorder’ (American Psychiatric Association,2013a,b). They show an overlap in symptoms, causes andtreatments, making it difficult to establish an accuratediagnosis, until now made on the basis of criteria (Table 1).For instance, although only 18% of patients with FM hadbeen diagnosed with CFS, 80% of patients with CFS hadreceived a diagnosis of FM (Aaron et al., 2000). Where allindividuals with CFS report fatigue, 86% of individuals withFM do too. And conversely; while all individuals with FMreport arthralgia, 88% of individuals with CFS do too(Kanaan et al., 2007). Considering the demonstrated over-lap and the increasing tendencies toward a similar treat-ment approach of these syndromes we will take the“lumper” point of view by examining CFS and FM as anentity (Wessely and White, 2004). Disorders e such as

body awareness interventions in fibromyalgia and chronic fatiguework & Movement Therapies (2014), http://dx.doi.org/10.1016/

Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome 3

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fibromyalgia and chronic fatigue syndrome e which arecharacterized by chronic, medically unexplained fatigue,exercise and stress intolerance are associated with phys-ical, mental, social and professional inability (VanHoudenhove and Luyten, 2008). Although the significantnegative impact on quality of life, there is still a lack ofunderstanding of the predisposing, precipitating andperpetuating factors. This lack of understanding createsnot only confusion for patients and caregivers, but also alack of recognition, problematic interactions between(medical) disciplines, feelings of meaninglessness or stig-matization and a negative impact on the employability orsocial participation of these patients (Van Dieren andVingerhoets, 2007). There is often little spontaneousimprovement of symptoms in FM/CFS and there is still aneed for effective approaches in the management of thispopulation. To date, most research has been focused onexercise therapy and cognitive behavior therapy (CBT) inFM/CFS, with limited and moderate effect (VanHoudenhove and Luyten, 2008; Hsu et al., 2010). The lackof emphasis upon psychological stress regulation within the‘traditional therapies’ is a possible cause for the minimaleffect on pain. Van Houdenhove and et al. (2001) findingsshow that “CFS and FM may remain (at least in part)frustrating because a substantial subgroup of patients mayneed a more comprehensive therapeutic approach,including experiential/psychodynamic and systemic psy-chotherapy, and/or adequate psychopharmacological sup-port (p.26)”. Also important to note is that in addition tophysical symptoms patients with long-lasting pain oftencomplain of lack of confidence and trust in their body alongwith feelings of depression and/or anxiety (Gyllenstenet al., 2010). Anxiety and depression are therefore themost common comorbidities in these populations(Henningsen et al., 2003). Perpetuating factors such as af-fective, personality and behavioral factors are essential emaybe even key factors e within therapy, which indirectlysupports the assumption of a need for a more comprehen-sive approach (Van Houdenhove and Luyten, 2008; VanHoudenhove et al., 2004). Besides, therapists are oftennot aware of what is ‘hidden’ in bodily symptoms and canbe referred to as the inner experience and meaning-bestowing. This aspect has to some extent been studiedfrom more phenomenological points of view, but still de-serves more attention in order to understand the relation-ship between bodily symptoms and life experiences forpatients with musculoskeletal disorders and pain(Gyllensten et al., 2010).

Body awareness interventions

Body-oriented approaches, which facilitate the develop-ment of internal integration, the felt experience of innerconnectivity and skills for authentically expressing internalphenomena can offer a possible solution. In the past clini-cians assumed that an increased body awareness (BA)would lead to somatosensory amplification, more severeanxiety symptoms, hypochondria and thus an unfavorableclinical outcome (such as more pain). Mehling et al. (2009)show some findings that seem to contradict this traditionalunderstanding of body awareness. The same author and

Please cite this article in press as: Courtois, I., et al., Effectiveness ofsyndrome: A systematic review and meta-analysis, Journal of Bodywj.jbmt.2014.04.003

colleagues define body awareness as “the subjective,phenomenological aspect of proprioception and inter-oception that enters conscious awareness, and is modifi-able by mental processes including attention,interpretation, appraisal, beliefs, memories, conditioning,attitudes and affect (p.1)” (Mehling et al., 2011). But, in-dividuals who experience bodily sensations of normalquality as a very intense and disturbing experience are lessaccurate in detecting subtle bodily sensations. Thus theability to detect these subtle sensations (i.e. body aware-ness) can be viewed as a process that is not the same assomatosensory amplification (Mehling et al., 2009). It hasbeen previously suggested that body awareness could beuseful in the treatment of chronic diseases such as chroniclow back pain, chronic renal failure, congestive heart fail-ure and irritable bowel syndrome (Mehling et al., 2011). Ithas also been shown that through bodily experiences andreflections patients can develop a more positive experienceof their body and self (Gyllensten et al., 2010).

These body (awareness)-oriented interventions e whichwe describe under the broad umbrella of body awarenessinterventions (BAI) e are directed towards an awareness ofhow the body is used in terms of body function, behaviorand interaction with the self and others (Gyllensten et al.,2010; Gard, 2005). In a physiotherapeutic context, bodyawareness has a twofold definition: (1) the experience ofthe body (i.e. experience dimension) and (2) the actionsand behavior in movements and activities (i.e. movementdimension) (Gyllensten et al., 2010). In ‘movementdimension’, the body awareness therapy aims to normalizeposture, balance, breathing and muscular tension or stiff-ness which are visible and experienced in the movementpattern (Gyllensten et al., 2010; Gard, 2005). In ‘experi-ence dimension’, the body awareness therapy emphasizesthe subjective bodily experiences. This review will mainlyfocus on the latter.

Information from ‘within’ the body

According to converging evidence from functional imagingstudies, subjective bodily experiences are processed andestablished through the interoceptive network (Critchleyet al., 2004; Craig, 2009). The interoceptive system isactivated via stimuli such as heartbeat, hunger, thirst,sexual arousal, light or sensual touch. This afferent inputfrom small-diameter fibers (A-delta and C) follow thelamina 1 spinothalamocortical tract and project informa-tion of the physiological condition of the body to the thal-amus and subsequently to the insular cortex (Craig, 2002;Schleip et al., 2012). The insular cortex is hierarchicalorganized: the posterior portion receives primary sensoryinput; the mid-insula integrates this bodily informationwith other sensory modalities such as homeostatic motorfunctions, environmental and hedonic conditions (re-rep-resentation); finally, the anterior insular cortex (AIC) is thehighest integrative level which leads to a meta-representation of the bodily state (Craig, 2009, 2003).The latter has also a strong e and important e connectionwith the anterior cingulate cortex (ACC). The motivationaland behavioral aspect (ACC) and the subjective feelings(AIC) together form a global emotional moment (Craig,

body awareness interventions in fibromyalgia and chronic fatigueork & Movement Therapies (2014), http://dx.doi.org/10.1016/


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2009). It can be concluded that there is already strongevidence indicating that the AIC is a unique neural sub-strate that regulates homeostasis based on physiologicalhealth of the body and subjective well-being and conse-quently highlights it’s role in body awareness. This alsomeans that an alteration in the activation of the AIC canlead to an altered body awareness (Craig, 2009). If theinsular function e as part of the interoceptive network ecan be altered and consequently has an effect on clinicaloutcomes, touch-based therapy (i.e. hands-on) can be animportant therapeutic approach since touch is incorporatedinto the interoceptive pathway.

Objective of the study

It can be concluded that FM and CFS e as part of MUS e arecomplex disorders that still frustrate patient and caregiver.Although the main complaints are rather somatic of origin,also personality traits such as alexithymia and cognitiveprocessing (mentalization) play an important role in thispopulation. Finally, current treatments are eitherpsychological-oriented or body-oriented approaches.Cognitive behavioral therapy and exercise therapy are themost commonly used interventions with only limited tomoderate effect. Since this population or ‘disorder’ chal-lenges the body-mind dualism, a more integrative

Table 2 Search strategy.

MeSH terms: ‘Fibromyalgia’, ‘Fatigue Syndrome, C‘Gestalt Therapy’, ‘Relaxation Thera‘Yoga’, ‘Tai Ji’, ‘Dance Therapy’, ‘Ac

Free text words: ‘Fibromyalg*’, ‘(“muscular rheumatisAND myofascial [tiab] AND pain [tiabdisease OR diseases))’, ‘(myalgic [tia“chronic fatigue”)’, ‘(”body awarenepsychotherap*)’, ‘Rolfing [tw]’, ‘bodytissue” AND (therapie* OR therapy OR‘(Alexander [tiab] AND (therapie* OR‘(“felt sense” OR “Focusing-oriented(therapie* OR therapy OR treatment*‘(Fascia* AND (therapie* OR therapy[tiab] OR Tai-ji [tiab] OR “Tai Chi” Otherapies”)’, ‘(“breathing exercise” Otraining [tiab])’, ‘(“Qi Gong” [tw])’,‘(Hypnoses [tiab] OR Mesmerism [tiab(therapie* OR therapy OR treatment*‘Pilates’, ‘(Dance AND (therapie* OR‘Trager [tiab]’, ‘(“Bowen Therapy”)’,‘(“Tui na” [tiab] OR Tuina [tiab])’, ‘(

Cochrane Highly SensitiveSearch Strategy foridentifying randomizedtrials in Medline:

#1 randomized controlled trial [pt]#2 controlled clinical trial [pt]#3 randomized [tiab]#4 placebo [tiab]#5 clinical trials as topic [mesh: noex#6 randomly [tiab]#7 trial [ti]#8#1 OR#2 OR#3 OR#4 OR#5 OR#6 OR#9 animals [mh] NOT humans [mh]#10#8 NOT#9

Please cite this article in press as: Courtois, I., et al., Effectiveness ofsyndrome: A systematic review and meta-analysis, Journal of Bodyj.jbmt.2014.04.003

treatment model is needed. The objective of this study is tocarry out a comprehensive review of the available litera-ture on the effectiveness of BAI in FM and CFS. Secondly wewill make a distinction between hands-on and hands-off BAIsince touch-based interventions might have a more promi-nent role in the treatment of complex or difficult painbased on their interaction with the interoceptive pathway.

Methods

Studies were identified by a comprehensive computerizedsearch on Medline, Cinahl, PEDro, Web of Knowledge, Psy-cINFO and Cochrane Central. Since Pubmed is a very largedatabase and to not miss studies, a preliminary search wascarried out. Pubmed was searched using MeSH terms andfree text words on pathology and intervention and also theCochrane Highly Sensitive Search Strategy for identifyingrandomized trials in Medline was used (see Table 2). OnCinahl, PEDro, Web of Knowledge, PsycINFO and CochraneCentral we searched on pathology (‘Fibromyalgia’ or‘Chronic Fatigue Syndrome’) without the combination of anintervention. The selection and evaluation of studies wasmade upon established inclusion criteria and assessed bytwo independent readers. Disagreements were dissolved byconsensus among these two primary readers and consultinga third person.

hronic’, ‘massage’, ‘Hypnosis’, ‘Autogenic training’,py’, ‘Breathing exercises’, ‘Exercise Movement Techniques’,upressure’m”)’, ‘Fibromyosit* ‘, ‘Fibrositis [tiab]’, ‘(diffuse [tiab]])’’ (“chronic fatigue” AND (syndrom* OR disorder* ORb] AND encephalomyelitis [tiab])’, ‘(postviral [tiab] ANDss” OR “bodily awareness”)’, ‘(“body oriented” ANDwork*’, ‘Craniosacral AND massage [tiab]’, ‘((“Softtreatment* OR technique* OR intervention*))’,therapy OR treatment* OR technique* OR intervention*))’,” OR “self-focus” [tiab])’, ‘(“functional integration” ANDOR technique* OR intervention*)’, ‘Feldenkrais [tiab]’,

OR treatment* OR technique* OR intervention*))’, ‘(TaijiR Taijiquan [tiab])’, ‘(“Movement therapy” OR “movementR “breathing exercises”)’, ‘(“respiratory muscle” AND

‘Mindfulness [tiab]’, ‘Pesso [tiab]’, ‘Mensendieck [tiab]’,])’, ‘((Mentalization-based OR Mentalization-based) ANDOR technique* OR intervention*))’, ‘(“Resseguier Method”)’,therapy OR treatment* OR technique* OR intervention*))’,‘Euton*’, ‘(Shiatsu [tiab] OR Acupression [tiab])’,

Reichian OR “Orgone Therapy”)’, ‘Sophrolog*’.

p]

#7



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We focused on randomized controlled trials (RCTs).These trials had to assess the effectiveness of bodyawareness interventions; that is, interventions that directlyor indirectly focused on increasing body awareness. Theincluded interventions are based upon several studiesconcerning body awareness and mind body therapies(Gyllensten et al., 2010; Mehling et al., 2011, 2009; Gard,2005; Baranowsky et al., 2009) and by a clinical expert.Table 3 represents all the included BAI. Eligible studypopulations are participants diagnosed with FM or CFS,possibly in combination with anxiety and/or depression ascomorbidities, not as primary diagnosis. All age categoriesstarting from 6 years were included.

Since enhancing body awareness is the main objective ofBAI, we included body awareness as primary outcomemeasure (primary studies). Adequate therapy consists ofaddressing the possible comorbidities as well as optimalpain control to maximize the health related quality of life(HRQoL). For that reason, we are also interested in impact,pain, anxiety, depression and HRQoL as secondary outcomemeasures (secondary studies). These are relevant outcomemeasures taken into account to measure the effectivenessof BAI in FM and CFS. We planned to compare the effect ofBAI versus different control conditions (usual care/waiting

Table 3 Included BAI.

Hands-on:

- Massage- Soft tissue techniques- Rolfing (structuralintegration)

- Alexander therapy- Feldenkrais (functionalintegration)

- Rosen method Bodywork- Fascia therapy- Cranio-sacral therapy- Reichian bodywork- Shiatsu- Tuina- Trager work- Bowen

Hands-off:

- TaiChi- Yoga- Movement therapya

- Feldenkrais: awarenessthrough movement (ATM)

- Breathing exercises- Relaxation: progressiverelaxation of Jacobson

- Meditation: mindfulness,focusing

- Pesso-therapy- Mensendieck- Gestalt therapy- Hypnosis- Mentalization-basedtreatmentb

- Basic body awarenesstherapy (Basic BAT)

- Body-oriented psychotherapy- Resseguier mMethod- Pilates- Dance therapy- Eutonia- Sophrology

a Some interventions (for example yoga and TaiChi) will beappointed as movement therapy. We screened title and ab-stract to determine if ‘movement therapy’ is used in thiscontext (BA techniques) and not as a synonym of exercisetherapy. When they use it as a synonym for exercise therapy,the study was excluded.b We are interested in the bodily aspects of mentalization.


list, sham procedure, or other intervention) and to comparethe effect of hands-on BAI with hands-off BAI.

Statistical analyses included comparisons of continuousdata. For each outcome we extracted final post-treatmentvalues in both the intervention and control arm of thestudy (mean, standard deviation (SD), and total number ofanalyzed subjects). If SD was not available, it was calcu-lated using mean value, number of analyzed participantsand p-value. We used a p-value of 0.1 if p-values werereported as ‘not significant’ (n.s.), and the least optimisticp-value if p-values were presented as inequalities (forexample: for a p-value of <0.01, we used a p-value of0.01). If results were reported as mean change scoresinstead of final values, they were statistically combinedwith final values only when the effect was expressed as amean difference. For outcomes where different scaleswere used across studies, the pooled estimate of effect isreported as a standardized mean difference (95% CI). If anoutcome was measured using the same scale or question-naire in all the trials, it is reported as a mean difference(95% CI). Heterogeneity was tested using the Q-test forheterogeneity and the amount was expressed as I2. Weused a similar method to test for subgroup differences. Arandom effects model was used for statistical pooling.Meta-analysis was carried out using Review Manager 5.2.

Results

7.107 articles were identified and screened. Based on titleand abstract, 149 articles met the inclusion criteria. Fiftystudies were withheld after removing duplicates (85studies) and studies which were excluded after consulting athird person (14 studies). Five studies reported on bodyawareness as an outcome and were assigned to the “pri-mary studies” group, whereas 45 studies reported only onsecondary outcomes (“secondary studies” group). Based onthe full-text, we excluded 22 studies not meeting studycriteria and included one more that was retrieved from areference list. Finally, 29 studies were included in this re-view (1 reporting on the primary outcome and 28 reportingonly on secondary outcomes) (Fig. 1).

Of the 29 included studies, 7 studies compared twodifferent BAI (table 4) (Altan et al., 2009; Castel et al.,2007; Da Silva et al., 2007; Field et al., 2002, 2003;Haanen et al., 1991; Kendall et al., 2000) and in case of 4studies it was impossible to extract data because ofincomplete (Alnigenis et al., 2001; Horwitz et al., 2006;Weissbecker et al., 2002) or no useful data (Castro-Sanchez et al., 2011a). These 11 studies are not includedin the meta-analysis, leaving 18 studies suitable for meta-analysis (Astin et al., 2003; Brattberg, 1999; Carson et al.,2010; Castro-Sanchez et al., 2011b, 2011c; Ekici et al.,2009; Field et al., 1997; Haak and Scott, 2008; Ho, 2012;Jones et al., 2012; Maddali Bongi et al., 2010; Mannerkorpiand Arndorw, 2004; Mataran-Penarrocha et al., 2011;Menzies et al., 2006; Schmidt et al., 2011; Sephton et al.,2007; Sunshine et al., 1996; Wang et al., 2010) (table 5). Ofthose 18 studies, 7 studies used hands-on BAI and 11 studiesused hands-off BAI as experimental condition. Also thecontrol condition differed across studies with 8 studiesusing usual care or waiting list (Carson et al., 2010; Haak


Figure 1 Flowchart.


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and Scott, 2008; Ho, 2012; Maddali Bongi et al., 2010;Mannerkorpi and Arndorw, 2004; Menzies et al., 2006;Schmidt et al., 2011; Sephton et al., 2007), 4 studiesusing sham therapy such as disconnected magnotherapy,ultrasound or TENS (Castro-Sanchez et al., 2011b,c; Fieldet al., 1997; Mataran-Penarrocha et al., 2011) and 5studies using other interventions such as education andsupport (Astin et al., 2003; Jones et al., 2012), discussiongroups (Brattberg, 1999), manual lymph drainage therapy(Ekici et al., 2009) and didactic lessons and stretching(Jones et al., 2012) as control condition. One study wasdivided in part A en B since it compared 3 conditionsincluding massage (BAI), TENS and sham TENS (Ho, 2012).Only 3 studies investigated the effectiveness of BAI on CFS(Haanen et al., 1991; Field et al., 1997; Ho, 2012), whereasthe other 26 studies focused on FM. Sample size variedbetween 20 and 177 subjects with mean age varying from30 to 57 years in studies included in the meta-analysis.

Except for impact (Fibromyalgia Impact Questionnaire;FIQ) and body awareness (Body Awareness Rating Scale;BARS), outcomes were measured with multiple scales. Foroutcome pain following scales were included: Regional PainScale (RPS), Visual Analogue Scale (VAS), McGill PainQuestionnaire (MPQ), Brief Pain Inventory (BPI), PainPerception Scale (PPS) and the appropriate subscale of theMedical Outcome Study Short-form 36 (SF-36). Studies


measuring anxiety used mostly State-Trait Anxiety In-ventory (STAI), except one study which used part of Hos-pital Anxiety and Depression Scale (HADS). Depression wasmeasured using Center for Epidemiological StudiesDepression Scale (CES-D), Beck’s Depression Inventory (BDI)and again a part of the HADS. Especially HRQoL wasmeasured in many different ways including SF-36 and SF-12, Quality of Well Being (QWB), The World Health Orga-nization Quality of Life BREF (WHOQOL-BREF), Quality ofLife Profile for the Chronically Ill (PLC), Nottingham HealthProfile (NHP) and Quality of Life Scale (QOLS). In theabsence of total scores on test batteries, solely scores fromrelevant subscales were extracted to use in the meta-analysis. For the SF-36 or SF-12 we extracted the mentalfunctioning score, the state anxiety score (how they feel atthe present time) in the STAI and sensory pain in the PPS.The mental component in the SF-36 survey was chosen overthe physical component since potential perpetuating fac-tors in CFS and FM are e besides physical factors e moredirected towards perceptual-cognitive, affective, person-ality, behavioral and social factors (Van Houdenhove andLuyten, 2008). These factors are more covered in themental aspect of the SF-36 survey (vitality, social func-tioning, role-emotional and mental health). State anxietyrepresents the anxiety level in the present moment andinteracts with particular threatening situations. Trait



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anxiety refers to a general level of anxiety or stress, ismore related to personality and therefore difficult tochange in short term. Finally, the sensory aspect of painperception in de PPS was chosen over the affective pain todetermine whether there has been any of increased sen-sory amplification. Interventions directed towards focusingupon the body are e unjustified e brought into relationshipwith somatosensory amplification. However, the ability todetect subtle bodily sensations (i.e. body awareness) canbe viewed as a process that is not the same as somato-sensory amplification (Mehling et al., 2009).

Overall quality of included studies was made upon re-view authors’ judgments about each risk of bias for eachincluded study. Studies were graded as ‘high quality’ if theyhad at least five positive ratings (4 of 29 included studies),‘moderate quality’ if they had two negative ratings and oneor more unclear ratings (9 of 29 included studies), and ‘lowquality’ if they had more than two negative ratings or onlytwo positive ratings (16 of 29 included studies). The lowquality of a study was often due to the presence of per-formance bias since most studies were unable to blindparticipants or therapists (see Figure 2; supplementarymaterials).

Subgroups were made based on hands-on BAI versushands-off BAI and type of control condition. Still, pre-planned subgroup-analysis did not reduce heterogeneity foroutcome measures FIQ and pain. Therefore, we performeda post-hoc analysis by analyzing subgroups based on qualityof the studies. Results are discussed following outcomes inprimary and secondary studies. We will describe the overalleffect, overall heterogeneity and between subgroupdifferences.

Primary studies

Of the 29 studies involved in this review, only one ran-domized controlled trial used body awareness as outcomemeasure (Mannerkorpi and Arndorw, 2004). This study ofMannerkorpi and Arndorw (2004) comprised 36 female pa-tients, ranging from 18 to 65 years and fulfilling the diag-nosis of FM according to the ACR 1990 criteria (meansymptom duration of 10 years). The control group consistedof 17 subjects receiving no intervention. They were askedto continue with their normal daily life without any changesin medication or activity. The experimental group received14 sessions (1.5 h each session, once a week in groups of8e10) body awareness therapy, which comprised variousbreathing and postural techniques and qigong. The BARSand the FIQ were used as primary outcome measures,whereas two tests for muscle function (maximum gripstrength and the Chair Test) were used as secondaryoutcome measures. A semi-structured interview in theexperimental group assessed the experiences of the treat-ment sessions. Results reveal a significant improvement onbody awareness in the experimental group compared withthe control group (inter-group analysis). The intra-groupanalysis revealed the same significant beneficial effect inthe experimental group, which was not found in the controlgroup. Results on the FIQ are included in this meta-analysis.The authors conclude: “body awareness therapy combinedwith Qigong resulted in improved movement harmony, but


no improvements were found for the symptoms or musclefunction. The Qigong program including lengthy standingdoes not appear to be generally recommendable for pa-tients with FM with long symptom duration due to thereported adverse effects. Qigong movements performedwhile changing position might be more feasible for thispopulation, and should be evaluated in future studies”. Theresults must be interpreted with care due to a high drop-out rate (possible attrition bias), small sample size and apossible performance bias since it was impossible to blindpatients and/or therapists. There is also insufficient infor-mation available in the study to evaluate the randomizationmethod.

Secondary studies

FIQOverall, there is moderate quality evidence that BAI havepositive significant effects on the FIQ (MD �5.55; CI �8.71to �2.40) compared with other control conditions (11 trials,684 subjects). We pooled data from three high quality(Carson et al., 2010; Maddali Bongi et al., 2010; Schmidtet al., 2011), three moderate quality (Castro-Sanchezet al., 2011b; Jones et al., 2012; Wang et al., 2010) andfive low quality studies (Astin et al., 2003; Brattberg, 1999;Ekici et al., 2009; Mannerkorpi and Arndorw, 2004; Menzieset al., 2006). The overall heterogeneity is very strong (I2

92%, p-value of <0.00001) which cannot be explained bydifferences in control intervention or type of BAI (hands-on/hands-off) since the heterogeneity remains strongwithin subgroups (usual care or waiting list I2 Z 95%; shamI2 not applicable; other intervention I2 Z 89%; hands-on BAII2 Z 91%, hands-off BAI I2 Z 93%). There are no subgroupsdifferences based on hands-on BAI versus hands-off BAI(I2 Z 0%, p-value of 0.78) or based on type of controlcondition (I2 Z 0%, p-value for between subgroup differ-ences of 0.47). Because of unexplainable heterogeneity(Fig. 3), we conducted a post-hoc subgroup analysis basedon quality of the studies (highemoderateelow). Results ofthis post-hoc analysis show differences in effect betweensubgroups (I2 Z 73.4%) with a strong within-subgroup het-erogeneity for low quality (I2 Z 95%) and high qualitystudies (I2 Z 83%). For studies of moderate quality, resultswere more homogeneous (I2 Z 13%). Still, it’s important toconsider the amount of high and/or moderate versus lowquality studies. (See forest plots I, II, III; supplementarymaterials).

PainOverall, there is a statistically significant effect on pain(SMD �0.39, CI �0.75 to �0.02) in favor of the BAI group (10trials, 613 subjects). Two studies met the criteria for highquality (Maddali Bongi et al., 2010; Menzies et al., 2006),whereas one study was of moderate (Kendall et al., 2000)and seven studies of low quality (Astin et al., 2003;Brattberg, 1999; Castro-Sanchez et al., 2011c; Ekiciet al., 2009; Field et al., 1997; Mataran-Penarrocha et al.,2011; Menzies et al., 2006). Again, strong overall hetero-geneity was measured (I2 Z 79%, p-value of <0.00001)which persisted within subgroups (usual care or waiting listI2 Z 87%; sham I2 Z 62%; other intervention I2 Z 89%;


Table 4 Studies comparing two BAI.

Study ID Sample size Mean age(SD orrange)

Diseaseduration(SD or range)

Inclusioncriteria forstudyparticipants

Control group (CG)& number analyzed

Experimental group(EG) & numberanalyzed

Outcomes Results

Altan et al.,2009

n Z 50 49.16 y(7.51)

/ 1. Diagnosis ofFM accordingto ACRcriteria

2. Age 24 to63 y

3. Admitted torheuma-tology clinic

n Z 25Group 1: Pilatesexercise program

n Z 24Group 2: Homeexercise relaxation &stretching program

Primary: VAS, FIQSecondary: tenderpoints count,algometric score,chair test, NHP

There was significantimprovementobserved in pain andFIQ immediately aftertreatment (12 weeks)in the Pilates group.No significantimprovement wasobtained in therelaxation/stretchinggroup. Difference inpain and FIQ betweentwo groupsdisappeared at week24.

Castel et al.,2007

n Z 45 43.7 y(range 25e68)

106.5 months(range6e360)

1. Diagnosis ofFM accordingto ACRcriteria

2. Sufferingfrom pain forat least 6months

n Z 15Relaxation

n Z 30Hypnosis:

� n Z 15 with anal-gesia suggestions

� n Z 15 with relax-ation suggestions

McGill PainQuestionnaire (PRI-S,PRI-A), VAS

Hypnosis withanalgesia suggestionshad a greater effecton the intensity (VAS)and the sensorialdimension (PRI-S) ofpain. The effect ofhypnosis withrelaxation suggestionis no greater than thatof relaxation. Thelatter may be due tothe lack of empiricaldifferences betweenthem.

Da Silva et al.,2007

n Z 40 EG:44.4 y (11)OG:46.3 y (8.9)

/ 1. Diagnosis ofFM accordingto ACRcriteria

2. No otherconditionsthat could

Relaxing Yoga (RY)n Z 17

Relaxing Yoga plusTouch (RYT)Touch Z Tui Namassagen Z 16

FIQ, pain threshold attender points, verbalgraduation of pain,VAS

Both groups showed asignificant decrease inFIQ scores after thetreatment. A verysignificant decrease ofpain intensity in thecomparison of VASvalues before and

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justifychronic pain

3. Age 25e60 y4. Normal

cognitivefunction andthe ability tounderstandinstruction

after each session wasverified in both groups(immediate significantchanges in 6 of the 8RY sessions and in all 8RYT sessions). The RYTgroup perceived moresignificant immediatepre tot postsessiondecreases in VAS painintensity than the RYgroup in just two ofthe eight sessions,which may beexplained by the factthat the RY groupalone had alreadysignificant results. TheRYT patients didn’tmaintain theseimprovements.

Field et al.,2002

n Z 24 50.9 y / 1. Diagnosis ofFM accordingto ACRcriteria

Progressive musclerelaxation therapyn Z 12

Massage therapyn Z 12

Immediate effects:STAI, POMSLonger term effects:CES-D, Timex watchfor activity duringsleep, daily sleep log,NRS for pain, fatigueand stiffness, illnessand medication use,tenderpoints by adolorimeter, salivasamples (substance P)

Both groups showeddecreased anxiety anddepressed mood afterthe first and lastsessions. The massagegroup experienceddecreased depressionand number of tenderpoints, improved sleepand assessments bythe physician (courseof disease and pain),less symptoms and areduced substance Plevel as comparedwith the relaxationgroup.

Field et al.,2003

n Z 40 53.1 y / 1. Diagnosis ofFM accordingto ACRcriteria

Progressive musclerelaxation therapyn Z 20

Self administeredmovement/massage(eutony)n Z 20

STAI, POMS, RPS Both groups showeddecreased anxiety andpain after the first andlast sessions. Howeverthe experimentalgroup showed

(continued on next page)

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Table 4 (continued )

Study ID Sample size Mean age(SD orrange)


Inclusioncriteria forstudyparticipants

Control group (CG)& number analyzed

Experimental group(EG) & numberanalyzed

Outcomes Results

improvement in mood,lower anxiety and painacross the course ofthe study.

Haanen et al.,1991

n Z 40 30e65 y 8.5 y(range1.5e40 y)

1. Patientswith re-fractory FMfor at least 6months(criteriaproposed bySmythe andMoldofsky)

n Z 20Physical therapy:massage,mensendieck method(muscle relaxation)

n Z 20Hypnotherapy

Patient’s assessment:Duration of morningstiffness (min), VAS(for muscle pain,fatigue on awakening,sleep disturbance andglobal assessment),HSCL-90Physician’sassessment:dolorimeter fortenderpoints (TMS),overall assessmentsby VAS

There was animprovementobserved for theassessments of musclepain, fatigue onawakening, sleepdisturbance, patient’soverall assessmentand HSCL total scorein the hypnotherapygroup compared to thephysical therapygroup. This decreasepersisted for 3 monthsafter finishing thehypnotherapy. Nosignificant differenceswere found formorning stiffness,physician’s overallassessment and TMSbetween both groups.The patients improvedonly subjectively.

Kendall et al.,2000

n Z 20 EG:46.2 y (5.8)CG:46.9 y (9.7)

EG: 4 y (2.3)CG: 3.2 (3.5)

1. Diagnosis ofFM accordingto ACRcriteria

Mensendieckn Z 9

BAT (by Roxendal)n Z 9

VAS, FIQ, CSQ, ASES,QOLS, compliance ona 5-point ordinalscale, TreatmentUtility Questionnaire,disability on a 5-pointscale

The BAT group hadimproved globalhealth at 18 monthsfollow-up but hadworsened immediatelyafter the program. Inthe Mensendieckgroup there was animprovementimmediately after and

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at18

-month

follow-up

ontheFIQ.ASE

Spain

andothersymptoms

showedim

prove

ments

immediately

after,

at

6-month

and18

-month

follow-up.CSQ

control

ofpain

wasincreased

immediately

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at6-month

follow-up.

Mensendieck

was

associatedwithmore

positive

change

sthan

BAT.


+ MODEL


hands-on BAI I2 Z 81%, hands-off BAI I2 Z 82%). Also, nobetween-subgroups differences in effect were measuredfor hands-on BAI versus hands-off BAI (I2 Z 0%, p-value forbetween subgroup differences of 0.90) or type of controlcondition (I2 Z 0%, p-value for between subgroup differ-ences of 0.85). Post-hoc analysis was conducted because ofthe strong heterogeneity (Fig. 4). These results revealeddifferences in effect between subgroups (I2 Z 74.3%), withhomogenous results in the high quality studies (I2 Z 0%) andheterogeneous results in the low quality studies (I2 Z 83%).Heterogeneity cannot be assessed within subgroup ‘mod-erate quality studies’ since this subgroup includes only onestudy. As in the results of the FIQ, the amount of high and/or moderate quality versus low quality studies is not equal.(See forest plots IV,V,VI; supplementary material).

AnxietyOverall, there is a statistically significant effect on anxiety(SMD �0.23, CI �0.44 to �0.02) in favor of the BAI group (7trials, 419 subjects). This finding was consistent acrosstrials (heterogeneity of I2 Z 11%, p-value of 0.34). Onestudy is of moderate (Sunshine et al., 1996) and one of high(Schmidt et al., 2011) quality. The five remaining studiesare classified as low quality (Castro-Sanchez et al., 2011c;Field et al., 1997; Haak and Scott, 2008; Mataran-Penarrocha et al., 2011; Brattberg, 1999), indicating acareful interpretation of results because the risk of bias.Results do not show differences in effect between any ofthe subgroups (I2 Z 0%, p-value for between subgroupdifferences ranging from 0.47 to 0.63). (See forest plotsVII,VIII; supplementary materials).

DepressionOverall, there is a significant benefit in favor of BAI ondepression (SMD �0.23, CI -0.39 to �0.06), compared withother control conditions (9 trials, 573 subjects). Again, thisfinding is consistent across trials (heterogeneity of I2 Z 0%,p-value of 0.73) and there is no difference in effect be-tween any of the subgroups (I2 Z 0%, p-value for betweensubgroup differences ranging from 0.70 to 0.73). Of nineincluded trials measuring depression, seven are qualified aslow (Astin et al., 2003; Brattberg, 1999; Castro-Sanchezet al., 2011c; Field et al., 1997; Haak and Scott, 2008;Mataran-Penarrocha et al., 2011; Sephton et al., 2007), oneas high (Schmidt et al., 2011) and one as moderate(Sunshine et al., 1996) quality. (See forest plots IX,X;supplementary materials).

Health related quality of lifeOverall, there is a statistically significant effect on HRQol(SMD 0.62, CI 0.35e0.90) in favor of the BAI group (6 trials,362 subjects). Two studies met the criteria for high quality(Ho, 2012; Schmidt et al., 2011), whereas the remainingfour studies were of low quality (Brattberg, 1999; Ekiciet al., 2009; Haak and Scott, 2008; Ho, 2012; MaddaliBongi et al., 2010; Schmidt et al., 2011). The overall het-erogeneity is mild (I2 Z 37%, p-value of 0.16), which ismainly due to the heterogeneity within subgroup ‘usualcare or waiting list’ or subgroup ‘hands-off BAI’ (I2 Z 61%,p-value of 0.05). No subgroup differences are measured(I2 Z 0%, p-value for between subgroup differences 0.42).(See forest plots XI,XII; supplementary materials).


Table 5 Studies included in meta-analysis.

Study ID Samplesize

Mean age(SD orrange)


Inclusion criteria forstudy participants

Control group(CG) & numberanalyzed

Experimentalgroup (EG) &number analyzed

omes Results

Astin et al.(2003)

n Z 128 47.7 y(SD 10.6)

Time sincediagnosis: -EG:4.89 y (SD 4.15)-CG:5.22 y(SD 7.31)

1. Clinical diagnosisof FM byown healthcare provider

2. Diagnosis of FMaccording to ACRcriteria

3. Age 18 to 70 y4. Able to read and

speak Englishfluently

5. Able to attendgroup intervention

6. Able to giveinformedconsent

Education andsupport(lectures ondifferent topiceach week)n Z 33

Mindfulnessmeditationtraining andQigongn Z 32 for FIQ &pain n Z 31 forBDI

ary: tenderts count,l myalgice, FIQ,cale painSF-36,

n walktest, BDI,ical careryndary:ng strategytionnaire

Mind-body interventiondid not suggest that thistreatment modality wassuperior to educationand support in thetreatment of FM. Bothgroups showedcomparable gains.Most part maintainedat 6 months follow-up.

Brattberg(1999)

n Z 52 48 y(SD 12.4)

/ 1. Diagnosis of FMaccording to ACRcriteria

No treatment(part A), ordiscussiongroup(part B)n Z 25

Connectivetissuemassagen Z 23

DRI, sleeprbanceinal scale),, FIQ, QOLS,ity of life onal scale

Connective tissuemassage has apositive effect onpain and reduces 37%depression and use ofanalgesics. It hasalso a beneficial effecton quality of life. Theseeffects appeared graduallyduring 10-week treatmentperiod, but disappearedwith follow-up (6 monthsafter treatment 90%pain was back).

Carson et al.(2010)

n Z 53 53.7 y(SD 11.5)

Time sincediagnosis:11.6 y(SD 7.2)

1. Only women2. Diagnosis of FM

according to ACRcriteria for atleast 1 year

3. Stable regimen ofpharmacologicand/or non-

Standard carewhile wait-listedn Z 26

Yoga-awarenessprogramn Z 22

ary: FIQ-Rndary: PGIC,Timed Chair

, SCBT, CPAQ,VMPCI, dailyes assessing, fatigue,ess, vigor,

The yoga awarenessprogram may be helpfulfor improving a widerange of symptomsand deficits in FMincluding pain,fatigue, stiffness,poor sleep, depression,

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Outc

Primpointotascorsubsfrom6 mitimemedhistoSecocopiques

VAS,distu(ordHADqualordin

PrimSecoTMS,RiseCSQ,diaripaindistr

pharmacologictreatment for�3 months

acceptance &relaxation

poor memory, anxiety,tenderness, poor balance,environment sensitivity(FIQ-R) and limitedstrength (TimedChair Rise). Also less useof maladaptive copingstrategies was observed inthe experimental group.

Castro-Sanchezet al. (2011a)

n Z 64 EG:49.32 y(SD 11.63)CG:46.29 y(SD 12.29)

/ 1. Diagnosis of FMaccording to ACRcriteria

2. Belong to theAlmeriaFibromyalgiaAssociation

3. Age 18 to 65 y4. No regular

physical activity5. Agreement to

attend eveningtherapy sessions

Sham treatmentwithdisconnectedmagnotherapydevicen Z 29

Massage-myofascialrelease therapyn Z 30

VAS, pressurealgometer,STAI, BDI,PSQI, SF-36

Post-treatment valuesreveal an improvement intrait anxiety, quality ofsleep, pain and qualityof life in the experimentalgroup versus controlcondition. Improvementslast until 1-monthfollow-up.At 6 months post-intervention there wereonly significant differencesin the quality of sleepindex. No differences instate anxiety or BDI(versus baseline andbetween groups)

Castro-Sanchezet al. (2011b)

n Z 94 54.4 y(range45e-65)

/ 1. Age 40 to 65 y2. Agreement to

attend eveningtherapy sessions

3. Limitation of usualactivities due topain on at least1 day in theprevious 30 daysand/or moderateor worse averagepain level (�4 on10 point scale)

Sham short-waveand ultrasoundtreatmentn Z 41

Myofascialreleasetechniquesn Z 45

Primary: numberof tender points,McGill PainQuestionnaire,stabilometer forpostural stabilitySecondary: FIQ,clinical severityand globalassessment ofimprovement(both on Likertscale)

FM patients showed asignificant reduction inpain but no significantdecrease in posturalstability as a resultof myofascial therapy.Also, a significantimprovement was foundin fatigue, stiffnessand number of daysfeeling goodimmediately afterthe therapy.

Ekici et al.(2009)

n Z 50 EG: 36.96 y(�8.88)CG: 38.84 y(�6.38)

/ 1. Diagnosis of FMaccording toACR criteria

2. Age 25 or older

Manual lymphdrainagetherapyn Z 25

Connectivetissue massagen Z 25

Primary: VASSecondary: PPTwith a hand-heldalgometry, NHP,FIQ

Both groups led tosignificant and progressiveimprovements basedon NHP, VAS, PPT andFIQ-total at the end of


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Study ID Samplesize






Outcomes Results

3. Femaleout-patients

4. Moderate pain(�4 on VAS)before baselinevisit

the treatment period.The manual lymphdrainage therapy showedmore improvements onsome subitems of FIQ(morning tirednessand anxiety).

Ekici et al.(2009),continued

/ 5. Pain in neck orshoulder region

6. Never beentreated for FM

7. Volunteered toparticipate

Field et al.(1997)

n Z 20 47 y / No inclusioncriteria mentioned.Subjects with CFSwere recruitedfrom referralsby localphysicians.

Sham TENSn Z 10(no informationavailable; 100%datapostulation)

Massage therapyn Z 10(no informationavailable; 100%data postulation)

Immediate effects:POMS, STAI, VAS,salivary cortisolLonger termeffects: CES-D,PFRA, pain &sleep questionnaire,dolorimeter, urinesamples forcatecholamine’sand cortisol

Results in this studysuggest greaterimprovements inself-report measuresand biochemical valuesin favor of the massagegroup versussham therapy. They pointout that human touch ordeeper pressure may berequired than thatproduced by theTENS roller.

Haak (2008) n Z 57 53 y(range27e53 y)

15 y 1. A FM diagnosisfor at least6 months

2. Age 18 y or older3. Female

Waiting listn Z 28

Qigongn Z 28

STAI, BDI,WHO-Qol-bref,daily self-reportson a visualnumerologicalscale for pain,sleep andpsychologicalhealth anddistress

Results show significantpositive effect on pain,degree of inconvenienceas result of pain andincreased ability tocontrol pain comparedwith pre-treatmentand controlgroup. Also, significantresults werefound for degree ofrestoration followingsleep compared to

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pre-treatmentin the experimental groupand regarding aspects ofpsychological health anddistress in favor of theQigong group.

Ho (2012) n Z 64 EG:42.1 y(range23e52)CG:42.5 y(range29e51)

/ 1. Diagnosis of CFSaccording toUnited States CDC

2. Age 18 to 55 y

Waiting listn Z 28 after5 weeksn Z 25 after4 months

Qigong exercisetrainingn Z 27 after5 weeks andafter 4 months

Primary:self-perceivedfatigue symptomsseverity (Chalder’sFatigue Scale) andphysical and mentalfunctioning(12-item SF)

Immediately after therapy(5weeks), the experimentalgroup showed significantimprovements comparedto the control group onthe total fatigue score,physical fatigue score,mental fatigue score andmental functioning score.This was maintained at4 months.

Ho (2012),continued

Secondary:telomerase activityin peripheralblood mononuclearcells

Only the physical scorewas not significantlychanged. Telomeraseactivity was significantlyimproved in theexperimental groupwhen compared to thecontrol group.

Jones et al.(2012)

n Z 101 54 y(range40.7e74.1)

18.4 y 1. Diagnosis of FMaccording to ACRcriteria andapproval bya health careprovider forparticipation

2. Age 40 y or older

Educationn Z 47

Tai Chi (8-form)n Z 51

Primary: FIQSecondary: BPI,Global PSQI, TUG,reach test, storktest, upperextremity flexibilityby externaland internalrotation ofthe shoulders

The experimental groupshowed improvementson symptoms, physicalfunction, quality ofsleep, self-efficacyand functional mobilitycompared to thecontrol group.On the otherhand, upper bodyflexibility was notsignificantly improvedin either group.No adverse effects werenoted.

Maddali(2010)

n Z 44 45.5 y(�11.79)

51 y(�4.7)

1. Diagnosis of FMaccording toACR criteria

Waiting listn Z 19

ResseguierMethodn Z 22

SF-36, RPS, FIQ,NRS (pain, qualityof movement,sleep, ability to

The experimental groupshowed significantimprovement on theSF-36, FIQ, RPS,


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Study ID Samplesize






omes Results

x bodymind)

perceived pain,quality of movement,sleep and ability to relaxmind and body. All resultsmaintained after 6 monthsfollow-up, except theFIQ score.

Manner-korpi(2004)

n Z 36 45y(SD 8.3)

10 y(SD 8.5)


2. Age 18 to 65 y3. Speaking Swedisch

Continue normaldaily activitiesn Z 10

BAT (breathing &posturaltechniques)þ Qigongn Z 12

ary: BARS, FIQndary: Grippitsure, Chairþ semi-cturedrviews in therimental group

Movement harmony(measured with the BARS)improved during the3-month treatmentprogram, whereas severityof symptoms and musclefunction did not improve.

Mataran-Penarrochaet al. (2011)

n Z 104 49.08 y(�14.17)

/ 1. Diagnosis of FMby rheumatology

2. Age 16 to 65 y3. Agreement to

attend afternoontherapy sessions

Sham ultrasoundtreatment(disconnected)n Z 41

Craniosacraltherapyn Z 43

SF-36, PSQI,STAI

Significant improvementswere found on stateanxiety, trait anxiety,pain, quality of life andPSQI in favor of theexperimental group aftera 25-week treatmentperiod. An improvementin sleep (duration, habitualsleep efficiency and dailydysfunction) persisted for1 year after

Menzies et al.(2006)

n Z 48 49.6 y(SD 10.53)

/ 1. Diagnosis of FM2. Age 18 or older3. MMSE score of

more than 254. FIQ score of

more than 20

n Z 24Usual care

n Z 24Guided imagery(audiotaped) þusual care

PQ, FIQ,, doseeonse effect

Differences in pain werenot statistically significantand small enough to notbe considered as clinicallyimportant. Also imagerydosage was not significant.Functional status and self-efficacy showed significantdifferences between theexperimental and controlgroup.

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Outc

relaand

PrimSecomeateststruinteexpeVAS,BDI,

SF-MASESresp

Schmidt et al.(2011)

n Z 177 52.5 y(SD 9.6)

14.3 y(SD 10.2)


2. Women, 18to 70 y

3. Command ofthe Germanlanguage andmotivation toparticipate

A) Activecontroln Z 56B) Waiting listn Z 59(3-armed trial)

Mindfulness-basedstress reductionn Z 53

imary: PLCcondary: FIQ,S-D, STAI, PSQI,S, FMI, GCQ,-point goaltainment scaled VAS duringterview

Mindfulness-based stressreduction cannot berecommended as aneffective interventionfor women with FM sinceno group effects uponHRQoL were found and itdid not prove to be betterthan either a wait-list oran active control group.Although, subjects in theexperimental groupappeared to benefit most.

Sephton et al.(2007)

n Z 91 48.2 y(SD 10.6)

Time sincediagnosis: eEG: 4.5 y(SD 3.6) eCG: 4.9 y(SD 5.2)

1. Physicianverificationof their FMdiagnosisaccording toACR criteria

2. Age 18 or older3. Able to attend a

group that meetweekly

Waiting listn Z 39

Mindfulness-basedstress reductionn Z 51

Iontrol variablesch as FIQ, SSQd 4-item VASr pain are notesented in thesults)

Mindfulness-based stressreduction interventionsignificantly reducesdepressive symptomscompared with thecontrol conditionimmediately after theintervention period.Slopes analyses revealeda persistent positiveeffect over all 3assessments (baseline,post-treatmentand 2-months follow-up).

Sunshine et al.(1996)

n Z 30 49.8 y(range18e80)

/ 1. Diagnosis of FMaccording toACR criteria

A) Sham TENSn Z 10B) TENSn Z 10(no informationavailable; 100%data postulation)

Massage therapyn Z 10(no informationavailable; 100%data postulation)

mediate effects:AI, POMS, salivaryrtisold-of-study effects:lorimeter test,terview on pain,eep and dailynctioning,S-D

The experimental groupshowed improvements onanxiety, depression andcortisol levels immediatelyafter the therapy sessionson the first and last day ofthe study. The TENS groupshowed similar changes,but only at the last session.Subjects also reportedfewer symptoms suchas pain, stiffness,fatigue and difficultsleeping in themassage group and


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Sunshine et al.(1996),continued

the TENS group improvedsolely on the physician’sassessment of clinicalcondition compared withthe first session. ShamTENS group improved alsoon the physician’sassessment but to a lesserextent.

Wang et al.(2010)

n Z 66 Experimental:49.7 y (�11.8)control: 50.5 y(�10.5)

Duration ofFM-relatedpain:- EG:11.8 y(�6.9)- CG: 10 y(�7.2)


2. Age 21 or older

Didactic lessonsand stretchingexercisesn Z 33

Tai Chin Z 33

Pri ary: FIQ(ba eline e end)Sec ndary:FIQ (weekly), VAS,nu ber of tendersite , 6-minutewa test, PSQI,CE D,Ou omeExp ctationsfor xercise Scale,CP , SF-36

At 12 weeks, the tai chigroup had clinicallysignificant improvementsin the FIQ score andmeasures used to assesspain, sleep quality,depression and qualityof life. Effects werestill present at 24 weeks.No adverse effects werereported.

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Figure 2 Review author’s judgments about each risk of biasfor each included study.


+ MODEL


Discussion

The aim of this systematic review and meta-analysis was toassess the effectiveness of BAI in FM and CFS. We con-ducted a search on Medline, Cochrane Central, PsycINFO,Web of Knowledge, PEDro and Cinahl. A total of 29 ran-domized controlled trials were included. We were able topool data from 18 trials, which revealed a positive signifi-cant effect in favor of BAI on the FIQ, pain, anxiety,depression and HRQoL (Figure 5). However, there is a strongoverall heterogeneity on the FIQ and pain which do notdecrease within subgroups, based on hands-on versushands-off BAI or type of control intervention. If findings arecalled ‘heterogeneous’, results differ between studies(variability among studies). This can be due to clinical,methodological or statistical diversity. Consequently, thesestudies can’t predict the effect of the intervention (posi-tive or negative) on FIQ and pain. Only post-hoc analysisbased on quality of included studies show a significantsubgroup differences on the FIQ and pain, with very het-erogeneous findings in low quality studies and more ho-mogeneous findings in moderate quality studies. Anxiety,depression and HRQoL show a low to moderate overallheterogeneity but do not reveal significant subgroupdifferences.

Only 4 studies were of high quality and 4 studies ofmoderate quality, whereas 10 studies were of low meth-odological quality. Although most of the studies used theAmerican College of Rheumatology (ACR) classificationcriteria for FM and United States Centers for Disease Con-trol (CDC) inclusion criteria for CFS, both syndromes stillrepresents a very heterogeneous population (clinical het-erogeneity). Also the inclusion of different forms of BAImight be an explanation for the obtained heterogeneity(methodological heterogeneity). Still, a combination of in-terventions was chosen since the objective of this system-atic review was to explore literature on the effectivenessand use results to contribute to a wider question about BAI.The distinction between hands-on and hands-off in-terventions e which did not decrease heterogeneity e wasan important sub-question that remains unanswered. Thiscan be an important scope in the future since literaturealready demonstrates the possible facilitating process oftouch-based intervention in body awareness.

A remarkable finding is the limited number of random-ized controlled trials investigating BAI in CFS (3 studies).This may be due to the fact that CFS as diagnosis is morefrequently used in the domain of psychotherapy, such asCGT. Additionally, patients with FM are more often referredto a body-oriented therapy by their general physician orrheumatologist.

Another important finding is that only one study usedbody awareness as outcome measure. Body awareness canbe measured in various ways such as questionnaires orobservation scales. Most studies used outcome measuresthat are related to explicit symptoms, whereas bodyawareness is more an implicit and subtle aspect of bodilyexperiences. Also, body awareness appears to be domi-nated by the assumption that heightened body awarenessleads to somatosensory amplification and e in that way e isa maladaptive outcome (Mehling et al., 2009). Also, the


Figure 3 Effect of body awareness interventions on the Fibromyalgia impact Questionnaire (FIQ) score: subgroup analyses.


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type of included studies can be an important restrictorsince there exist already a lot of qualitative data for anumber of body awareness-enhancing approaches inchronic musculoskeletal pain conditions (Hoffren-Larssonet al., 2009; Mannerkorpi and Gard, 2003; Mehling et al.,2005). These studies show a growing body of evidencethat BAI may provide psychological and pain-related ben-efits. Besides the interaction between patient and thera-pists, which enhance resources of the patient and lead to apositive patient outcome, also the therapists own move-ment awareness and embodied presence is of considerabletherapeutic importance and might therefore play animportant role in the effectiveness of BAI (Gyllenstenet al., 1999; Skjaerven et al., 2010).

A possible limitation of this systematic review is the in-clusion of studies with a low methodological quality and

Figure 4 Effect of body awarene


trials with a small sample size. Secondly, we did notincluded 3 studies in the meta-analysis because of incom-plete data.

We can conclude that although the overall positive ef-fect of BAI, results are too heterogeneous to implement inclinical practice, especially for FIQ and pain. This meansthat it’s not possible to predict a positive outcome on FIQand pain for patients with FM or CFS treated with BAI, sinceresults are variable between studies. These heterogeneousfindings may be explained by methodological and clinicalheterogeneity between studies. For anxiety, depressionand HRQol results reveal more homogenous findings in favorof BAI. Finally, we cannot make a recommendation aboutthe type of BAI, hands-on or hands-off. Larger, well-controlled and blinded randomized controlled trials areneeded to provide conclusive evidence. Also a combination

ss on pain :subgroup analyses.


Figure 5 Summary estimates of effects of body awareness interventions versus usual care/waiting list, sham treatment or otherintervention.


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of quantitative and qualitative data can have an addedvalue since it give us, besides objective parameters, alsosubjective and more experience related information.

Appendix A. Supplementary data

Supplementary data related to this article can be found athttp://dx.doi.org/10.1016/j.jbmt.2014.04.003.

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