- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429624
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80262
- University of Colorado Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David J Tanaka, M.D., University of Colorado, Denver
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 94-0085
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.
Clinical Trials on Neck Pain
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on acetaminophen
-
Massachusetts General HospitalCompletedPain, Postoperative | Infertility, FemaleUnited States
-
Kaveh Aslani, MDCompletedAirway Obstruction | Tonsillitis | Difficulty SwallowingUnited States
-
Taipei Medical University WanFang HospitalUnknownCervical Radiculopathy | Radicular Pain | Acute Neck Pain | Cervicobrachial PainTaiwan
-
Medical University of South CarolinaCompletedPain, PostoperativeUnited States
-
MallinckrodtTerminatedAcute Pain, PostoperativeUnited States
-
Duke UniversityCompletedOsteoarthritis | Acetaminophen | Arthroplasty, Hip ReplacementUnited States
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruiting
-
Spectrum Health HospitalsTerminatedHip FractureUnited States
-
Babiash, Kimberly H., M.D.Unknown
-
Beth Israel Deaconess Medical CenterNational Center for Research Resources (NCRR); Harvard UniversityCompletedAcetaminophen Poisoning | Acetaminophen Metabolism | Drug Metabolism by ExcipientsUnited States