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

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco's Osher Center for Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga; Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.	Behavioral: Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Roland Morris Disability Questionnaire	Baseline to 3 months post-intervention.

Secondary Outcome Measures

Outcome Measure	Time Frame
Numeric Rating Scale for Pain	Baseline to 3 months post-intervention.
Pain Medication Usage Survey	Baseline to 3 months post-intervention.

Other Outcome Measures

Outcome Measure	Time Frame
Inflammatory pain related cytokines	Baseline to 3 months post-intervention.
Heart rate variability	Baseline to 3 months post-intervention.
International Physical Activity Questionnaire	Baseline to 3 months post-intervention.
Pain Catastrophizing Scale	Baseline to 3 months post-intervention.
Five Facet Mindfulness Questionnaire	Baseline to 3 months post-intervention.
Multidimensional Assessment of Interoceptive Awareness	Baseline to 3 months post-intervention.
Patient Reported Outcomes Measurement Information System: Pain - Behavior	Baseline to 3 months post-intervention.
Patient Reported Outcomes Measurement Information System: Pain - Interference	Baseline to 3 months post-intervention.
Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression	Baseline to 3 months post-intervention.
Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety	Baseline to 3 months post-intervention.
Patient Reported Outcomes Measurement Information System: Physical Function	Baseline to 3 months post-intervention.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Bowes Fund for Innovative Research
• Investigators: Principal Investigator: Sarah Corey, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UCSFCHR12-09424