JSM 2011 Online Program

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Abstract Details

Activity Number: 48
Type: Invited
Date/Time: Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
Sponsor: WNAR
Abstract - #300496
Title: Statistical Issues in Designing Unblinded Randomized Controlled Studies for Nonpharmaceutical Therapy Focusing on Massage and Yoga Interventions for Neck and Back Pain
Author(s): Andrea Cook*+ and Robert Wellman and Dan Cherkin and Karen Sherman
Companies: Group Health Research Institute and Group Health Research Institute and Group Health Research Institute and Group Health Research Institute
Address: , Seattle, WA, 98101,
Keywords: unblinded ; clinical trial ; alternative medicine ; dosing
Abstract:

The design of unblinded studies to evaluate non-pharmaceutical therapies, such as a study to assess the effectiveness of yoga for backpain, can lead to challenging statistical issues. A potential solution for unblinding is to include an attention control comparison, i.e. a treatment that mimics the amount of time and attention received by the treatment group, but is thought not to have a specific effect on the participants, but this may not be feasible. This has lead to the evaluation of potential mechanisms due to the therapy by including a active control group such as exercise in a study evaluating yoga for back pain to assess which theoretical components of yoga (i.e. stress reduction or conscious body awareness) account for the effect of yoga on the reduction of back pain beyond physical activity through mediation analyses. Other design issues have also arisen in evaluating the dose necessary to provide equivalent treatment for minimal cost such as which minimal number, length, or weekly cumulative dose of massage allows for equivalent benefit in reduction of neck pain. This talk presents two alternative medicine studies detailing the statistical issues and potential solutions.


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