Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bowes Fund for Innovative Research
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01739140
First received: November 27, 2012
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Behavioral: Yoga

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric Rating Scale for Pain [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Pain Medication Usage Survey [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Inflammatory pain related cytokines [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • International Physical Activity Questionnaire [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Five Facet Mindfulness Questionnaire [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Interoceptive Awareness [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement Information System: Pain - Behavior [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement Information System: Pain - Interference [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement Information System: Physical Function [ Time Frame: Baseline to 3 months post-intervention. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Behavioral: Yoga

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739140

Locations
United States, California
University of California, San Francisco's Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Bowes Fund for Innovative Research
Investigators
Principal Investigator: Sarah Corey, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01739140     History of Changes
Other Study ID Numbers: UCSFCHR12-09424
Study First Received: November 27, 2012
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014