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Completed

NCT Number: NCT01739140

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Primary outcomes

  1. Roland Morris Disability Questionnaire

    Time frame: Baseline to 3 months post-intervention.

Secondary outcomes

  1. Numeric Rating Scale for Pain

    Time frame: Baseline to 3 months post-intervention.

  2. Pain Medication Usage Survey

    Time frame: Baseline to 3 months post-intervention.

Other outcomes

  1. Inflammatory pain related cytokines

    Time frame: Baseline to 3 months post-intervention.

  2. Heart rate variability

    Time frame: Baseline to 3 months post-intervention.

  3. International Physical Activity Questionnaire

    Time frame: Baseline to 3 months post-intervention.

  4. Pain Catastrophizing Scale

    Time frame: Baseline to 3 months post-intervention.

  5. Five Facet Mindfulness Questionnaire

    Time frame: Baseline to 3 months post-intervention.

  6. Multidimensional Assessment of Interoceptive Awareness

    Time frame: Baseline to 3 months post-intervention.

  7. Patient Reported Outcomes Measurement Information System: Pain - Behavior

    Time frame: Baseline to 3 months post-intervention.

  8. Patient Reported Outcomes Measurement Information System: Pain - Interference

    Time frame: Baseline to 3 months post-intervention.

  9. Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression

    Time frame: Baseline to 3 months post-intervention.

  10. Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety

    Time frame: Baseline to 3 months post-intervention.

  11. Patient Reported Outcomes Measurement Information System: Physical Function

    Time frame: Baseline to 3 months post-intervention.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bowes Fund for Innovative Research

Registry information

Acronym: YoMA

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Dec 3, 2012
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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