Yoga Dosing Study for Chronic Low Back Pain

NCT01761617 | Completed DMC

• 1 other identifier: 1R01AT005956-01A1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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.

Conditions

Back Pain Lower Back Chronic

Keywords

Yoga; Chronic Low Back Pain; CAM; Complementary and Alternative Medicine; Minorities

Outcome Measures

Primary Outcomes (2)

• Average pain intensity

  Measured on 0-10 scale; asked at baseline, 6 weeks and 12 weeks

  up to 12 weeks

• 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 Outcomes (2)

• Pain medication use

  up to 12 weeks

• Number of Participants with Adverse Events

  up to 12 weeks

Other Outcomes (3)

• Improvement in low back pain

  up to 12 weeks

• Patient satisfaction

  up to 12 weeks

• Health-related Quality of Life (SF-36)

  up to 12 weeks

Study Arms (2)

Yoga Class Twice Per Week

ACTIVE COMPARATOR

Participants attend two hatha yoga classes each week for 12 weeks.

Behavioral: Yoga class twice per week

Yoga Class Once per Week

ACTIVE COMPARATOR

Participants attend one hatha yoga class each week for 12 weeks.

Behavioral: Yoga class once per week

Interventions

Yoga class once per week BEHAVIORAL

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 Once per Week

Yoga class twice per week BEHAVIORAL

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.

Yoga Class Twice Per Week

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (6)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

South Boston Community Health Center

Boston, Massachusetts, 02118, United States

Location

Dorchester House Multi-service Center

Dorchester, Massachusetts, 02122, United States

Location

Codman Square Health Center

Dorchester, Massachusetts, 02124, United States

Location

Upham's Corner Health Center

Dorchester, Massachusetts, 02125, United States

Location

Roslindale Greater Medical and Dental Center

Roslindale, Massachusetts, 02131, United States

Location

Related Publications (2)

• 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.

  PMID: 24716775 DERIVED

• 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.

  PMID: 23878604 DERIVED

Study Officials

• Robert B Saper, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: January 7, 2013
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 6, 2018

Record last verified: 2013-01

Locations

US (6)