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Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA) (YoMA)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
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 > 3 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

  • University of California, San Francisco's Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga

Arm Description

Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.

Outcomes

Primary Outcome Measures

Roland Morris Disability Questionnaire

Secondary Outcome Measures

Numeric Rating Scale for Pain
Pain Medication Usage Survey

Full Information

First Posted
November 27, 2012
Last Updated
November 18, 2019
Sponsor
University of California, San Francisco
Collaborators
Bowes Fund for Innovative Research
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1. Study Identification

Unique Protocol Identification Number
NCT01739140
Brief Title
Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)
Acronym
YoMA
Official Title
Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Bowes Fund for Innovative Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to better understand how a yoga intervention helps improve symptoms in people with chronic low back pain. This study will be a 12-week intervention of about 24 participants with chronic low back pain where all individuals will receive weekly yoga classes and instructions for home practice. The purpose of this study is to collect feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH study.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Time Frame
Baseline to 3 months post-intervention.
Secondary Outcome Measure Information:
Title
Numeric Rating Scale for Pain
Time Frame
Baseline to 3 months post-intervention.
Title
Pain Medication Usage Survey
Time Frame
Baseline to 3 months post-intervention.
Other Pre-specified Outcome Measures:
Title
Inflammatory pain related cytokines
Time Frame
Baseline to 3 months post-intervention.
Title
Heart rate variability
Time Frame
Baseline to 3 months post-intervention.
Title
International Physical Activity Questionnaire
Time Frame
Baseline to 3 months post-intervention.
Title
Pain Catastrophizing Scale
Time Frame
Baseline to 3 months post-intervention.
Title
Five Facet Mindfulness Questionnaire
Time Frame
Baseline to 3 months post-intervention.
Title
Multidimensional Assessment of Interoceptive Awareness
Time Frame
Baseline to 3 months post-intervention.
Title
Patient Reported Outcomes Measurement Information System: Pain - Behavior
Time Frame
Baseline to 3 months post-intervention.
Title
Patient Reported Outcomes Measurement Information System: Pain - Interference
Time Frame
Baseline to 3 months post-intervention.
Title
Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression
Time Frame
Baseline to 3 months post-intervention.
Title
Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety
Time Frame
Baseline to 3 months post-intervention.
Title
Patient Reported Outcomes Measurement Information System: Physical Function
Time Frame
Baseline to 3 months post-intervention.

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 > 3 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Corey, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco's Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)

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