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

Chronic Low Back Pain Clinical Trial

— YoMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739140
• Other study ID #: UCSFCHR12-09424
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Yoga

Locations

Country	Name	City	State
United States	University of California, San Francisco's Osher Center for Integrative Medicine	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Bowes Fund for Innovative Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory pain related cytokines		Baseline to 3 months post-intervention.
Other	Heart rate variability		Baseline to 3 months post-intervention.
Other	International Physical Activity Questionnaire		Baseline to 3 months post-intervention.
Other	Pain Catastrophizing Scale		Baseline to 3 months post-intervention.
Other	Five Facet Mindfulness Questionnaire		Baseline to 3 months post-intervention.
Other	Multidimensional Assessment of Interoceptive Awareness		Baseline to 3 months post-intervention.
Other	Patient Reported Outcomes Measurement Information System: Pain - Behavior		Baseline to 3 months post-intervention.
Other	Patient Reported Outcomes Measurement Information System: Pain - Interference		Baseline to 3 months post-intervention.
Other	Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression		Baseline to 3 months post-intervention.
Other	Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety		Baseline to 3 months post-intervention.
Other	Patient Reported Outcomes Measurement Information System: Physical Function		Baseline to 3 months post-intervention.
Primary	Roland Morris Disability Questionnaire		Baseline to 3 months post-intervention.
Secondary	Numeric Rating Scale for Pain		Baseline to 3 months post-intervention.
Secondary	Pain Medication Usage Survey		Baseline to 3 months post-intervention.