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Clinical Trials/NCT00246350
NCT00246350
Completed
Phase 2

Dose-Response of Manipulation for Chronic Headache

University of Western States1 site in 1 country80 target enrollmentSeptember 2004

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Headache Disorders
Sponsor
University of Western States
Enrollment
80
Locations
1
Primary Endpoint
Modified Von Korff pain scale for headaches
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.

Detailed Description

Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits. Participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
July 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • History of cervicogenic headaches

Exclusion Criteria

  • Contraindications to spinal manipulation or massage
  • Use of chiropractic or therapeutic massage care prior to study entry
  • Use of any prophylactic prescription medication
  • Involved in any type of lawsuit prior to study entry
  • Headaches with several different causes

Outcomes

Primary Outcomes

Modified Von Korff pain scale for headaches

Secondary Outcomes

  • Modified Von Korff disability scale for headaches
  • Number of cervicogenic headaches
  • general physical and mental health status
  • patient satisfaction
  • neck pain

Study Sites (1)

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