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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429624
• Other study ID #: 94-0085
• Status: Completed
• Phase: N/A
• First received: January 30, 2007
• Last updated: February 4, 2013
• Start date: September 1994
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Chiropractic manipulation

Drug:
• acetaminophen

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Foundation for Chiropractic Education and Research (FCER)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5