ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02552992
Recruitment Status : Unknown
Verified September 2015 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Yoga Behavioral: Self-Directed Mind-Body Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Study Start Date : January 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Yoga Classes
Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.
Behavioral: Yoga
Active Comparator: Self-Directed Mind-Body Program
Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.
Behavioral: Self-Directed Mind-Body Program



Primary Outcome Measures :
  1. Change in Roland Morris Disability Questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in Numeric Rating Scale for Pain [ Time Frame: 6 months ]
  2. Change in Pain Medication Usage Survey [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Change in Strength testing (Biodex Dynamometer) [ Time Frame: 6 months ]
  2. Change in Trunk flexibility (sit-and-reach) testing [ Time Frame: 6 months ]
  3. Change in Lateral flexion (goniometer) testing [ Time Frame: 6 months ]
  4. Change in Pain Catastrophizing Scale [ Time Frame: 6 months ]
  5. Change in Multidimensional Assessment of Interoceptive Awareness [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02552992     History of Changes
Other Study ID Numbers: UCSFCHR14-14148
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

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