Yoga Dosing Study for Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly
      minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are
      pain intensity and measure of disability; secondary outcomes are pain medication use,
      treatment adherence, and health-related quality of life.
    

Detailed description: 
      Chronic low back pain (CLBP) affects 5-10% of U.S. adults annually and costs over $50 billion
      per year in direct health care expenditures. Individuals from low-income minority backgrounds
      are disproportionately impacted by CLBP due to disparities in access and treatment. Several
      recent studies suggest yoga is effective for CLBP. Yoga may also have other relevant benefits
      for CLBP patients, such as improved mood, stress reduction, and lower cost. However, there
      are no studies which directly compare different doses of yoga for CLBP. It is unknown if
      there is a meaningful dose- response effect of yoga for CLBP. If there is a dose/response
      effect, the magnitude of the effect is unknown. The total dose of a yoga intervention depends
      upon the duration of total intervention, frequency of yoga classes, duration of each yoga
      class, and home practice (amount, duration and frequency).

      To assess the impact of yoga dose, we propose conducting a Pilot Yoga Dosing Study for 96
      adults from Boston Medical Center. The Dosing Study will be a 12-week randomized controlled
      trial where participants are assigned to either once per week 75-minute yoga classes or twice
      per week 75 minute yoga classes.

      During this 12-week study, there will be three points of data collection (baseline, 6 weeks,
      12 weeks). In addition, little is known about the reliability of different forms of survey
      administration in low back pain trials. For example, it is unknown if telephone administered
      questionnaires or web-based data collection are reliable compared to the traditional paper-
      administered questionnaire.Therefore we will compare different methods of survey
      administration at each time point. The results of this Pilot will inform the design of a
      larger future comparative effectiveness RCT of yoga, physical therapy, and education for
      chronic low back pain.
    

Intervention name(s): Yoga class once per week; Yoga class twice per week
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The protocol consists of one 75-minute yoga class per week for 12 weeks. The 12 weeks are divided into four 3-week segments, each with a theme (e.g., "Listening to the Wisdom of the Body," "Engaging your Power"). The number of postures learned and degree of difficulty increases with each segment. The protocol provides variations and uses various aids (e.g., chair, yoga strap, yoga block) to accommodate a range of physical abilities. Classes are taught by a team of yoga instructors to ensure a low participant-to-teacher ratio.; The protocol consists of two 75-minute yoga classes per week for 12 weeks. The 12 weeks are divided into four 3-week segments, each with a theme (e.g., "Listening to the Wisdom of the Body," "Engaging your Power"). The number of postures learned and degree of difficulty increases with each segment. The protocol provides variations and uses various aids (e.g., chair, yoga strap, yoga block) to accommodate a range of physical abilities. Classes will have eight participants at a time and are taught by a team of two yoga instructors to ensure a low yoga participant-to-teacher ratio.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga; Chronic Low Back Pain; CAM; Complementary and Alternative Medicine; Minorities