Cervicogenic Headache Dose-Response

Study Overview
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Brief Summary
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This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.

Official Title
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Dose-Response of Manipulation for Cervicogenic Headache

Conditions
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Cervicogenic Headache

Intervention / Treatment
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* Other: Spinal Manipulation
* Other: Light Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic cervicogenic headache threshold pain level threshold headache frequency independently ambulatory English literate candidate for spinal manipulation Exclusion Criteria: contraindication to thrust spinal manipulation or massage most other headache types Recent manual/exercise therapy from licensed provider for head/neck threshold pain medication use pregnancy involvement with another pain study suspicion of unmanaged depression most cancers hypertension (at least stage II) complicating neurological/spinal conditions pre-randomization noncompliance or cannot/will not comply with protocols health-related litigation, claims, or disability compensation

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: High dose spinal manipulation<br>18 visits for spinal manipulation | Other: Spinal Manipulation<br>* 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.<br>|
| Experimental: Moderate dose spinal manipulation<br>12 visits for spinal manipulation and 6 visits for light massage | Other: Spinal Manipulation<br>* 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.<br>Other: Light Massage<br>* 5 minutes of light pressure massage to the neck and upper back<br>|
| Experimental: Low dose spinal manipulation<br>6 visits for spinal manipulation and 12 visits for light massage | Other: Spinal Manipulation<br>* 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.<br>Other: Light Massage<br>* 5 minutes of light pressure massage to the neck and upper back<br>|
| Other: High dose massage<br>18 visits for light massage | Other: Light Massage<br>* 5 minutes of light pressure massage to the neck and upper back<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache days change from baseline for cervicogenic headache | Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score) | 0, 6, 12, 24, 39, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain change from baseline for cervicogenic headache | Average cervicogenic headache pain in the last four weeks evaluated by averaging daily headache diary pain scores. Pain is rated on a 0 to 11 numeric rating scale. | 0, 6, 12, 24, 39, 52 weeks | 
| Headache-related disability change from baseline for cervicogenic headaches | Headache Impact Test (HIT-6) | 0, 6, 12, 24, 39, 52 weeks | 
| Headache-related disability days change from baseline | Number of days in the last four weeks from recall unable to carry out daily work for at least one half day because of cervicogenic headache. | 0, 6, 12, 24, 39, 52 weeks | 
| EuroQol-5D change from baseline | Health-related quality of life | 0, 12, 24, 39, 52 weeks | 
| Average pain change from baseline for neck | Average neck pain in the last four weeks from recall. Pain is rated on a 0 to 11 numeric rating scale. | 0, 6, 12, 24, 39, 52 weeks | 
| Neck pain days change from baseline | Number of days with neck pain in last 4 weeks from recall. | 0, 6, 12, 24, 39, 52 weeks | 
| medication use change from baseline | Number days of use of prescription and nonprescription medications for headaches with neck pain | 0, 6, 12, 24, 39, 52 weeks | 
| Outside Care change from baseline | Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits | 0, 6, 12, 24, 39, 52 weeks | 
| Patient Satisfaction | Likert scale for success of care | week 12 | 
| Objective biomechanical measures change from baseline | Measures of cervical joint function and kinematics including global range of motion, spinal segmental joint restriction, pain pressure thresholds | 0, 6 weeks | 
| Quality-adjusted life years change from baseline | utility for cost-effectiveness analysis | 0, 12, 24, 39, 52 weeks | 
| Direct & Indirect costs change from baseline | Health services; lost work days and productivity | 0, 6, 12, 24, 39, 52 weeks | 
| Perceived headache average pain change from baseline for cervicogenic headache | Perceived change in average pain from baseline on a -10 to +10 (21-point) numeric rating scale | 0, 6, 12, 24, 39, 52 weeks | 
| Perceived headache improvement from baseline for cervicogenic headache | Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale. | 0, 6, 12, 24, 39, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy