Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga
Self-Directed Mind-Body Program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga Classes
Self-Directed Mind-Body Program
Arm Description
Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.
Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.
Outcomes
Primary Outcome Measures
Change in Roland Morris Disability Questionnaire
Secondary Outcome Measures
Change in Numeric Rating Scale for Pain
Change in Pain Medication Usage Survey
Full Information
NCT ID
NCT02552992
First Posted
August 18, 2015
Last Updated
November 18, 2019
Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund
1. Study Identification
Unique Protocol Identification Number
NCT02552992
Brief Title
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Official Title
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Classes
Arm Type
Experimental
Arm Description
Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.
Arm Title
Self-Directed Mind-Body Program
Arm Type
Active Comparator
Arm Description
Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Type
Behavioral
Intervention Name(s)
Self-Directed Mind-Body Program
Primary Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Numeric Rating Scale for Pain
Time Frame
6 months
Title
Change in Pain Medication Usage Survey
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in Strength testing (Biodex Dynamometer)
Time Frame
6 months
Title
Change in Trunk flexibility (sit-and-reach) testing
Time Frame
6 months
Title
Change in Lateral flexion (goniometer) testing
Time Frame
6 months
Title
Change in Pain Catastrophizing Scale
Time Frame
6 months
Title
Change in Multidimensional Assessment of Interoceptive Awareness
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
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