Spinal Manipulation for Treatment of Chronic Headaches

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dose-Response of Manipulation for Chronic Headache

Conditions
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Headache Disorders

Intervention / Treatment
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* Procedure: massage
* Procedure: massage
* Procedure: spinal manipulation
* Procedure: Spinal manipulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>8 light massage treatments | Procedure: massage<br>* 8 light massage treatments and hot pack<br>|
| Active Comparator: 2<br>16 light massage treatments | Procedure: massage<br>* 16 light massage treatments and hot packs<br>|
| Experimental: 3<br>8 spinal manipulation treatments | Procedure: spinal manipulation<br>* 8 high velocity, low amplitude spinal manipulation treatments and hot pack<br>|
| Experimental: 4<br>16 spinal manipulation treatments | Procedure: Spinal manipulation<br>* 16 high velocity, low amplitude spinal manipulation treatments and hot pack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Von Korff pain scale for headaches |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Von Korff disability scale for headaches |  |  | 
| Number of cervicogenic headaches |  |  | 
| general physical and mental health status |  |  | 
| patient satisfaction |  |  | 
| neck pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headaches, Spinal manipulation, Massage, chiropractic