Yoga Dosing Study for Chronic Low Back Pain



Status:Completed
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 64
Updated:8/8/2018
Start Date:September 2011
End Date:December 2011

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Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population

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.

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.

Inclusion Criteria:

- 18-64 years old

- Current non-specific low back pain persisting >12 weeks. Mean low back pain intensity
for the previous week 4 or greater on a 0 to 10 numerical rating scale (0=no pain to
10=worst possible pain).

- English fluency sufficient to follow treatment instructions and answer survey
questions

- Willingness to list comprehensive contact information for at least one (preferably
two) friend, family member, or work colleague who will always know how to contact the
participant.

Exclusion Criteria:

- Use of yoga in the previous 6 months

- New CLBP treatments started within the previous month or anticipated to begin in the
next 12 months

- Pregnancy

- Back surgery in the previous three years

- Specific CLBP pathologies

- Severe or progressive neurological deficits

- Sciatica pain equal to or greater than back pain

- Active substance or alcohol abuse

- Active or planned worker's compensation, disability, or personal injury claims
We found this trial at
6
sites
Boston, Massachusetts 02118
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Boston, Massachusetts 02127
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Boston, MA
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Dorchester, Massachusetts 02122
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Dorchester, MA
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Dorchester, Massachusetts 02124
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Dorchester, MA
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Dorchester, Massachusetts 02125
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Dorchester, MA
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Roslindale, Massachusetts 02131
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Roslindale, MA
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