Physical CAM Therapies for Chronic Low Back Pain

August 16, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 00000
        • Harvard Medical School
      • Boston, Massachusetts, United States, 00000
        • Harvard Vanguard Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Low back pain duration of at least 3 months;
  • Low back pain occurring in the past week;
  • No numbness or tingling in the lower extremities;
  • No pain that radiates to below the knee;
  • No use of massage, chiropractic or acupuncture for any reason in the past year;
  • Able to attend scheduled appointments;
  • Able to hear, read, and understand English;
  • No low back pain surgery in the past 3 years;
  • No unexplained weight loss;
  • No previous vertebral or spinal fractures;
  • No previous non-traumatic bone fractures;
  • No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or ankylosing spondylitis;
  • No cancer (except simple skin cancers) in the past 5 years;
  • No pacemakers;
  • No bleeding problems or anticoagulant use;
  • No major organ transplants;
  • No oral corticosteroid use for more than 4 consecutive weeks during the past year;
  • Cannot be pregnant;
  • Must be able to get down to and up from the floor by yourself;
  • Able to walk 2 flat city blocks unassisted;
  • Willing to participate in periodic telephone interviews.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: David Eisenberg, MD, Harvard Medical School (HMS and HSDM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

August 1, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 16, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000622-01 (U.S. NIH Grant/Contract)
  • EisenbergD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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