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Completed

NCT Number: NCT02552992

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Self-Directed Mind-Body Program

Behavioral

Primary outcomes

  1. Change in Roland Morris Disability Questionnaire

    Time frame: 6 months

Secondary outcomes

  1. Change in Numeric Rating Scale for Pain

    Time frame: 6 months

  2. Change in Pain Medication Usage Survey

    Time frame: 6 months

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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