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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00429624
First received: January 30, 2007
Last updated: February 4, 2013
Last verified: January 2007
History of Changes
  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:

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
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00429624     History of Changes
Other Study ID Numbers: 94-0085
Study First Received: January 30, 2007
Last Updated: February 4, 2013
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 May 21, 2013