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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
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Chronic lower back pain

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2003
    Last Updated
    October 11, 2017
    Sponsor
    Kaiser Permanente
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)
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    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

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