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

January 30, 2007
February 4, 2013
September 1994
January 2007   (final data collection date for primary outcome measure)
Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5
Same as current
Complete list of historical versions of study NCT00429624 on ClinicalTrials.gov Archive Site
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Not Provided
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Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Neck Pain
  • Procedure: Chiropractic manipulation
  • Drug: acetaminophen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00429624
94-0085
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Foundation for Chiropractic Education and Research (FCER)
Principal Investigator: David J Tanaka, M.D. University of Colorado, Denver
University of Colorado, Denver
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP