Yoga Dosing Study for Chronic Low Back Pain (YLBP2)

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.

Study Overview

• Status: Completed
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Behavioral: Yoga class twice per week; Behavioral: Yoga class once per week

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02118
      • South Boston Community Health Center
    • Dorchester, Massachusetts, United States, 02124
      • Codman Square Health Center
    • Dorchester, Massachusetts, United States, 02125
      • Upham's Corner Health Center
    • Dorchester, Massachusetts, United States, 02122
      • Dorchester House Multi-Service Center
    • Roslindale, Massachusetts, United States, 02131
      • Roslindale Greater Medical and Dental Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medication use	Asked at baseline, 6 weeks and 12 weeks	up to 12 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient satisfaction	Satisfaction with treatment of low back pain	up to 12 weeks
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Robert B Saper, MD, MPH, Boston Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Yoga; CAM; Chronic Low Back Pain; Minorities; Complementary and Alternative Medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1R01AT005956-01A1 (U.S. NIH Grant/Contract)