Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

This study has been completed.

First Received on January 30, 2007. Last Updated on January 31, 2007 History of Changes

Sponsor:	University of Colorado, Denver
Collaborator:	Foundation for Chiropractic Education and Research (FCER)
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00429624

Purpose

The purpose of this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.

Condition	Intervention
Neck Pain	Procedure: Chiropractic manipulation Drug: acetaminophen

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

Resource links provided by NLM:

MedlinePlus related topics: Neck Injuries and Disorders

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5

Estimated Enrollment:	70
Study Start Date:	September 1994
Estimated Study Completion Date:	March 1996

Detailed Description:

Neck pain is a common complaint, approximately 10% of the population have neck pain. Many modalities are used to treat neck pain, but no therapy has been found to be clearly superior. We conducted a randomized controlled study of chiropractic manipulation versus medical therapy for chronic neck pain.

Subjects (n=70) with neck pain for more than 3 months but with no evidence of radiculopathy or myelopathy were randomized. Both groups were instructed to do neck exercises and use heat daily. The chiropractic group received 12 standardized manipulations over 6 weeks. Nurses saw the medical group on the same visit schedule and received acetaminophen 1,000 milligrams four times a day as needed. Blinded observer performed all measurements. The primary outcome measure was the Neck Disability Index (NDI). Secondary measures were pain via a visual analogue scale, global via Medical Outcome Study Short Form and range of motion via Cybex electronic inclinometer.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Neck pain for more than 3 months

Exclusion Criteria:

Cervical radiculopathy or myelopathy
Contraindications to cervical manipulation: metastatic cancer, coagulation disorder, cervical spine abnormalities, neuromuscular disease
Medical contraindications: uncontrolled hypertension, active coronary artery disease, history of cerebral vascular disease, alcohol or drug dependency, acetaminophen allergy
Active litigation involving neck pain
Medical or Chiropractic treatment within the past 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429624

Locations

United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262

Sponsors and Collaborators

University of Colorado, Denver

Foundation for Chiropractic Education and Research (FCER)

Investigators

Principal Investigator:

David J Tanaka, M.D.

University of Colorado, Denver

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00429624 History of Changes
Other Study ID Numbers:	94-085
Study First Received:	January 30, 2007
Last Updated:	January 31, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

Neck Pain
Chiropractic manipulation
Randomized controlled trial

Additional relevant MeSH terms:

Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012