Yoga Dosing Study for Chronic Low Back Pain

Back Pain Lower Back Chronic Clinical Trial

— YLBP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761617
• Other study ID #: 1R01AT005956-01A1
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	South Boston Community Health Center	Boston	Massachusetts
United States	Codman Square Health Center	Dorchester	Massachusetts
United States	Dorchester House Multi-service Center	Dorchester	Massachusetts
United States	Upham's Corner Health Center	Dorchester	Massachusetts
United States	Roslindale Greater Medical and Dental Center	Roslindale	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in low back pain	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.	up to 12 weeks
Other	Patient satisfaction	Satisfaction with treatment of low back pain	up to 12 weeks
Other	Health-related Quality of Life (SF-36)	The SF-36 is a multi-purpose, generalized health survey that assesses the health benefits produced by a wide range of different treatments.	up to 12 weeks
Primary	Average pain intensity	Measured on 0-10 scale; asked at baseline, 6 weeks and 12 weeks	up to 12 weeks
Primary	Modified Roland Morris Disability Questionnaire for back pain-specific disability	Roland Morris Disability Questionnaire is a widely used health status measure for low back pain; asked at baseline, 6 weeks and 12 weeks	up to 12 weeks
Secondary	Pain medication use	Asked at baseline, 6 weeks and 12 weeks	up to 12 weeks
Secondary	Number of Participants with Adverse Events	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.	up to 12 weeks