Bias Control in Trials of Bodywork: A Review of Methodological Issues

Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, USA.
The Journal of Alternative and Complementary Medicine (Impact Factor: 1.59). 05/2005; 11(2):333-42. DOI: 10.1089/acm.2005.11.333
Source: PubMed


To review and summarize the methodological challenges in clinical trials of bodywork or handson mind-body therapies such as Feldenkrais Method, Alexander Technique, Trager Work, Eutony, Body Awareness Therapy, Breath Therapy, and Rolfing, and to discuss ways these challenges can be addressed.
Review and commentary.
Search of databases PubMed and EMBASE and screening of bibliographies. Published clinical studies were included if they used individual hands-on approaches and a focus on body awareness, and were not based on technical devices.
Of the 53 studies identified, 20 fulfilled inclusion criteria. No studies blinded subject to the treatment being given, but 5 used an alternative treatment and blinded participants to differential investigator expectations of efficacy. No study used a credible placebo intervention. No studies reported measures of patient expectations. Patient expectations have been measured in studies of other modalities but not of hands-on mind-body therapies. Options are presented for minimizing investigator and therapist bias and bias from differential patient expectations, and for maintaining some control for nonspecific treatment effects. Practical issues with recruitment and attrition resulting from volunteer bias are addressed.
Rigorous clinical trials of hands-on complementary and alternative therapy interventions are scarce, needed, and feasible. Difficulties with blinding, placebo, and recruitment can be systematically addressed by various methods that minimize the respective biases. The methods suggested here may enhance the rigor of further explanatory trials.

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    • "A variety of therapeutic approaches often categorized as mind-body approaches claim to enhance body awareness[1] including yoga[2,3], TaiChi, Body-Oriented Psychotherapy[4], mindfulness based therapies/meditation[5], Feldenkrais[6], Alexander Method[7], Breath Therapy[8], and even massage[4,9,10] and mental training for athletic exercise and sport performance[11-13]. These approaches enjoy a growing popularity in the Western world[14]. "
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    ABSTRACT: Enhancing body awareness has been described as a key element or a mechanism of action for therapeutic approaches often categorized as mind-body approaches, such as yoga, TaiChi, Body-Oriented Psychotherapy, Body Awareness Therapy, mindfulness based therapies/meditation, Feldenkrais, Alexander Method, Breath Therapy and others with reported benefits for a variety of health conditions. To better understand the conceptualization of body awareness in mind-body therapies, leading practitioners and teaching faculty of these approaches were invited as well as their patients to participate in focus groups. The qualitative analysis of these focus groups with representative practitioners of body awareness practices, and the perspectives of their patients, elucidated the common ground of their understanding of body awareness. For them body awareness is an inseparable aspect of embodied self awareness realized in action and interaction with the environment and world. It is the awareness of embodiment as an innate tendency of our organism for emergent self-organization and wholeness. The process that patients undergo in these therapies was seen as a progression towards greater unity between body and self, very similar to the conceptualization of embodiment as dialectic of body and self described by some philosophers as being experienced in distinct developmental levels.
    Philosophy Ethics and Humanities in Medicine 04/2011; 6(1):6. DOI:10.1186/1747-5341-6-6
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    • "A variety of therapeutic approaches in common use throughout the world claim to enhance body awareness [72] including yoga [23], [73], TaiChi, massage [74]–[76], Body-Oriented Psychotherapy [74], mindfulness based therapies/meditation [41], Feldenkrais [77], Alexander Method [78], Breath Therapy [79], and even mental training for athletic exercise and sport performance [80]–[82]. These approaches are often categorized as mind-body approaches and/or manual therapies [83] and enjoy a growing popularity in the Western world [59] but frequently suffer from a lack of theory and methodologically weak research behind esoteric formulations and unfounded statements of benefits. "
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    ABSTRACT: Heightened body awareness can be adaptive and maladaptive. Improving body awareness has been suggested as an approach for treating patients with conditions such as chronic pain, obesity and post-traumatic stress disorder. We assessed the psychometric quality of selected self-report measures and examined their items for underlying definitions of the construct. PubMed, PsychINFO, HaPI, Embase, Digital Dissertations Database. Abstracts were screened; potentially relevant instruments were obtained and systematically reviewed. Instruments were excluded if they exclusively measured anxiety, covered emotions without related physical sensations, used observer ratings only, or were unobtainable. We restricted our study to the proprioceptive and interoceptive channels of body awareness. The psychometric properties of each scale were rated using a structured evaluation according to the method of McDowell. Following a working definition of the multi-dimensional construct, an inter-disciplinary team systematically examined the items of existing body awareness instruments, identified the dimensions queried and used an iterative qualitative process to refine the dimensions of the construct. From 1,825 abstracts, 39 instruments were screened. 12 were included for psychometric evaluation. Only two were rated as high standard for reliability, four for validity. Four domains of body awareness with 11 sub-domains emerged. Neither a single nor a compilation of several instruments covered all dimensions. Key domains that might potentially differentiate adaptive and maladaptive aspects of body awareness were missing in the reviewed instruments. Existing self-report instruments do not address important domains of the construct of body awareness, are unable to discern between adaptive and maladaptive aspects of body awareness, or exhibit other psychometric limitations. Restricting the construct to its proprio- and interoceptive channels, we explore the current understanding of the multi-dimensional construct and suggest next steps for further research.
    PLoS ONE 02/2009; 4(5):e5614. DOI:10.1371/journal.pone.0005614 · 3.23 Impact Factor
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    ABSTRACT: Hands-on mind-body techniques claim to help patients with low back pain (LBP) by focusing on body-awareness. Their efficacy has been studied only in a few controlled research studies of limited rigor. A randomized controlled clinical pilot trial of Breath Therapy (BT) was conducted to determine whether patients with cLBP would benefit from an approach primarily focusing on body-awareness. BT is a Western mind-body therapy developed in Germany that integrates body-awareness, breathing, meditation, and movement. Thirty-six patients seeking primary medical care for chronic LBP of at least 3 months duration were randomly assigned either to receive BT or PT at an academic medical center. Main outcome measures at baseline, 6-8 weeks, and 6 months were pain, function, and overall health. Balance as a potential surrogate for proprioception and body-awareness was measured at the beginning and end of treatment. Patients suffering from cLBP improved clinically with BT. Changes in standard self-reported LBP measures of pain and disability were comparable to changes measured following high-quality, extended PT. The full details of the study are published elsewhere [Mehling, W.E., et al., 2005. Randomized, controlled trial of breath therapy for patients with chronic LBP. Alternative Therapies in Health and Medicine 11 (4), 44-52].
    Journal of Bodywork and Movement Therapies 04/2006; 10(2):96-98. DOI:10.1016/j.jbmt.2005.09.003
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