Back to resultsRandomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chiropractic manipulation
acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Chiropractic manipulation, Randomized controlled trial
Eligibility 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
Sites / Locations
- University of Colorado Health Sciences Center
Outcomes
Primary Outcome Measures
Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5
Secondary Outcome Measures
Full Information
NCT ID
NCT00429624
First Posted
January 30, 2007
Last Updated
February 4, 2013
Sponsor
University of Colorado, Denver
Collaborators
Foundation for Chiropractic Education and Research (FCER)
1. Study Identification
Unique Protocol Identification Number
NCT00429624
Brief Title
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Official Title
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
September 1994 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Foundation for Chiropractic Education and Research (FCER)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Chiropractic manipulation, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Chiropractic manipulation
Intervention Type
Drug
Intervention Name(s)
acetaminophen
Primary Outcome Measure Information:
Title
Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Tanaka, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
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