Massage, Meditation, and Tai Chi for Chronic Lower Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tai chi
Mindfulness-based Stress Reduction program
Therapeutic massage
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria Chronic lower back pain
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00070915
First Posted
October 9, 2003
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00070915
Brief Title
Massage, Meditation, and Tai Chi for Chronic Lower Back Pain
Official Title
Relaxation-Related CAM Therapies for Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
This clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults.
Detailed Description
Despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. The pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial.
Participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). The participants assigned to each intervention will be divided equally between persons under and over age 65.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Tai chi
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction program
Intervention Type
Procedure
Intervention Name(s)
Therapeutic massage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Chronic lower back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C. Cherkin
Organizational Affiliation
Center for Health Studies
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Massage, Meditation, and Tai Chi for Chronic Lower Back Pain
We'll reach out to this number within 24 hrs