NCT01739140

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

November 27, 2012

Last Update Submit

November 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Roland Morris Disability Questionnaire

    Baseline to 3 months post-intervention.

Secondary Outcomes (2)

  • Numeric Rating Scale for Pain

    Baseline to 3 months post-intervention.

  • Pain Medication Usage Survey

    Baseline to 3 months post-intervention.

Other Outcomes (11)

  • Inflammatory pain related cytokines

    Baseline to 3 months post-intervention.

  • Heart rate variability

    Baseline to 3 months post-intervention.

  • International Physical Activity Questionnaire

    Baseline to 3 months post-intervention.

  • +8 more other outcomes

Study Arms (1)

Yoga

EXPERIMENTAL

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

Behavioral: Yoga

Interventions

YogaBEHAVIORAL
Yoga

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco's Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sarah Corey, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 3, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

December 1, 2015

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations