Yoga Dosing Study for Chronic Low Back Pain (YLBP2)
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|ClinicalTrials.gov Identifier: NCT01761617|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Lower Back Chronic||Behavioral: Yoga class once per week Behavioral: Yoga class twice per week||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Yoga Class Twice Per Week
Participants attend two hatha yoga classes each week for 12 weeks.
Behavioral: Yoga class twice per week
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.
Active Comparator: Yoga Class Once per Week
Participants attend one hatha yoga class each week for 12 weeks.
Behavioral: Yoga class once per week
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.
- Average pain intensity [ Time Frame: up to 12 weeks ]Measured on 0-10 scale; asked at baseline, 6 weeks and 12 weeks
- Modified Roland Morris Disability Questionnaire for back pain-specific disability [ Time Frame: up to 12 weeks ]Roland Morris Disability Questionnaire is a widely used health status measure for low back pain; asked at baseline, 6 weeks and 12 weeks
- Pain medication use [ Time Frame: up to 12 weeks ]Asked at baseline, 6 weeks and 12 weeks
- Number of Participants with Adverse Events [ Time Frame: up to 12 weeks ]Participants encouraged to contact study staff immediately if they have experienced an adverse event that may or definitely be a result of their involvement in the study. All data collections will include questions on whether the participant believes he/she incurred any possible intervention-related adverse events.
- Improvement in low back pain [ Time Frame: up to 12 weeks ]Participants asked to rate how their low back feels compared to when they began treatment on scale 0-6 where 0 is "extremely worsened" and 6 is "extremely improved." Asked at 6 weeks and 12 weeks.
- Patient satisfaction [ Time Frame: up to 12 weeks ]Satisfaction with treatment of low back pain
- Health-related Quality of Life (SF-36) [ Time Frame: up to 12 weeks ]The SF-36 is a multi-purpose, generalized health survey that assesses the health benefits produced by a wide range of different treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761617
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|South Boston Community Health Center|
|Boston, Massachusetts, United States, 02118|
|Dorchester House Multi-service Center|
|Dorchester, Massachusetts, United States, 02122|
|Codman Square Health Center|
|Dorchester, Massachusetts, United States, 02124|
|Upham's Corner Health Center|
|Dorchester, Massachusetts, United States, 02125|
|Roslindale Greater Medical and Dental Center|
|Roslindale, Massachusetts, United States, 02131|
|Principal Investigator:||Robert B Saper, MD, MPH||Boston Medical Center|