Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)

Chronic Low Back Pain Clinical Trial

Official title:

Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552992
• Other study ID #: UCSFCHR14-14148
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2016

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 study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability. This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic low back pain lasting > 6 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

• Self-Directed Mind-Body Program

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mount Zion Health Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Strength testing (Biodex Dynamometer)		6 months
Other	Change in Trunk flexibility (sit-and-reach) testing		6 months
Other	Change in Lateral flexion (goniometer) testing		6 months
Other	Change in Pain Catastrophizing Scale		6 months
Other	Change in Multidimensional Assessment of Interoceptive Awareness		6 months
Primary	Change in Roland Morris Disability Questionnaire		6 months
Secondary	Change in Numeric Rating Scale for Pain		6 months
Secondary	Change in Pain Medication Usage Survey		6 months