Clinical trial NCT01761617: Yoga Dosing Study for Chronic Low Back Pain
Official title: Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Keywords: Yoga
Chronic Low Back Pain
CAM
Complementary and Alternative Medicine
Minorities
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average pain intensity
timeFrame: up to 12 weeks
measure: Modified Roland Morris Disability Questionnaire for back pain-specific disability
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Pain medication use
timeFrame: up to 12 weeks
measure: Number of Participants with Adverse Events
timeFrame: up to 12 weeks
Other outcomes:
measure: Improvement in low back pain
timeFrame: up to 12 weeks
measure: Patient satisfaction
timeFrame: up to 12 weeks
measure: Health-related Quality of Life (SF-36)
timeFrame: up to 12 weeks
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: South Boston Community Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Dorchester House Multi-service Center
state: Massachusetts
city: Dorchester
country: United States
facility: Codman Square Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Upham's Corner Health Center
state: Massachusetts
city: Roslindale
country: United States
facility: Roslindale Greater Medical and Dental Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Robert B Saper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cerrada CJ, Weinberg J, Sherman KJ, Saper RB. Inter-method reliability of paper surveys and computer assisted telephone interviews in a randomized controlled trial of yoga for low back pain. BMC Res Notes. 2014 Apr 9;7:227. doi: 10.1186/1756-0500-7-227.
citation: Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.