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

NCT02552992 | Completed

• 1 other identifier: UCSFCHR14-14148
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Roland Morris Disability Questionnaire

  6 months

Secondary Outcomes (2)

• Change in Numeric Rating Scale for Pain

  6 months

• Change in Pain Medication Usage Survey

  6 months

Other Outcomes (5)

• Change in Strength testing (Biodex Dynamometer)

  6 months

• Change in Trunk flexibility (sit-and-reach) testing

  6 months

• Change in Lateral flexion (goniometer) testing

  6 months

Study Arms (2)

Yoga Classes

EXPERIMENTAL

Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.

Behavioral: Yoga

Self-Directed Mind-Body Program

ACTIVE COMPARATOR

Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.

Behavioral: Self-Directed Mind-Body Program

Interventions

Yoga BEHAVIORAL

Yoga Classes

Self-Directed Mind-Body Program BEHAVIORAL

Self-Directed Mind-Body Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 17, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 19, 2019

Record last verified: 2019-11