search
Back to results

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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 18, 2015
    Last Updated
    November 18, 2019
    Sponsor
    University of California, San Francisco
    Collaborators
    Mount Zion Health Fund
    search

    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)

    We'll reach out to this number within 24 hrs