Yoga Dosing Study for Chronic Low Back Pain (YLBP2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01761617
First received: December 4, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Back Pain Lower Back Chronic
Behavioral: Yoga class once per week
Behavioral: Yoga class twice per week
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Average pain intensity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Measured on 0-10 scale; asked at baseline, 6 weeks and 12 weeks

  • Modified Roland Morris Disability Questionnaire for back pain-specific disability [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Roland Morris Disability Questionnaire is a widely used health status measure for low back pain; asked at baseline, 6 weeks and 12 weeks


Secondary Outcome Measures:
  • Pain medication use [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Asked at baseline, 6 weeks and 12 weeks

  • Number of Participants with Adverse Events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Improvement in low back pain [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Satisfaction with treatment of low back pain

  • Health-related Quality of Life (SF-36) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    The SF-36 is a multi-purpose, generalized health survey that assesses the health benefits produced by a wide range of different treatments.


Enrollment: 96
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761617

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
South Boston Community Health Center
Boston, Massachusetts, United States, 02118
Dorchester House Multi-service Center
Dorchester, Massachusetts, United States, 02122
Upham's Corner Health Center
Dorchester, Massachusetts, United States, 02125
Codman Square Health Center
Dorchester, Massachusetts, United States, 02124
Roslindale Greater Medical and Dental Center
Roslindale, Massachusetts, United States, 02131
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Robert B Saper, MD, MPH Boston Medical Center
  More Information

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01761617     History of Changes
Other Study ID Numbers: 1R01AT005956-01A1
Study First Received: December 4, 2012
Last Updated: January 16, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Yoga
Chronic Low Back Pain
CAM
Complementary and Alternative Medicine
Minorities

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014