- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552992
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
November 18, 2019 updated by: University of California, San Francisco
This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP).
Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed.
This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability.
This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP.
For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living.
The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic low back pain lasting > 6 months
- Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).
- English language fluency
Exclusion Criteria:
- BMI > 40
- Inability to provide informed consent
- Recent diagnosis of abdominal aneurism
- Recent diagnosis of metastatic cancer
- Recent diagnosis of discitis
- Recent diagnosis of disk disease
- Recent diagnosis of spinal stenosis
- Recent diagnosis of spondylolisthesis
- Recent diagnosis of infectious cause of back pain
- Recent diagnosis of fracture of vertebra
- Recent diagnosis of Fibromyalgia
- Recent diagnosis of rheumatoid arthritis
- Recent diagnosis of ankylosing spondylitis
- Recent diagnosis of paralysis
- Pregnancy
- Prior or planned back surgery
- Blindness or severe vision problems
- Deafness or severe hearing problems
- Bipolar or manic depression and not taking medication
- Major depression
- Psychoses (major)
- a substance abuse condition
- Dementia
- Unable to get up and down from the floor
- Involvement in a lawsuit related to back pain
- Lack of transportation
- Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
- Currently (within the past 3 months) using yoga classes for more than 15 minutes per week
- Inability to be contacted by phone or email
- no computer access
- schedule does not allow for participation in classes/home practice
- planning to move out of town or take a long vacation during the period of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga Classes
Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.
|
|
Active Comparator: Self-Directed Mind-Body Program
Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Roland Morris Disability Questionnaire
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Numeric Rating Scale for Pain
Time Frame: 6 months
|
6 months
|
Change in Pain Medication Usage Survey
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Strength testing (Biodex Dynamometer)
Time Frame: 6 months
|
6 months
|
Change in Trunk flexibility (sit-and-reach) testing
Time Frame: 6 months
|
6 months
|
Change in Lateral flexion (goniometer) testing
Time Frame: 6 months
|
6 months
|
Change in Pain Catastrophizing Scale
Time Frame: 6 months
|
6 months
|
Change in Multidimensional Assessment of Interoceptive Awareness
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 18, 2015
First Submitted That Met QC Criteria
September 15, 2015
First Posted (Estimate)
September 17, 2015
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSFCHR14-14148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
Clinical Trials on Yoga
-
Universität Duisburg-EssenCompleted
-
University of Texas at AustinCompleted
-
Adiyaman University Research HospitalCompletedDepression | Stress | Anxiety | Psychological ResilienceTurkey
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaCompleted
-
NMP Medical Research InstituteWarwick Research Services; Yog-KulamCompleted
-
Northwestern UniversityCompleted
-
University of MinnesotaCompleted
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedDepression | Pain | Breast Cancer | FatigueUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Active, not recruitingProstate CarcinomaUnited States
-
Manhattan Physical Medicine and Rehabilitation,...New York UniversityCompleted