Manual Therapy and Exercise in Patients With Cervicogenic Headache

Study Overview
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Brief Summary
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Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.

Detailed Description
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Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.

Official Title
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Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache

Conditions
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Cervicogenic Headache

Intervention / Treatment
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* Other: Thrust Manipulation
* Other: Non-thrust Mobilization and Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria Headache frequency of at least one per week for a minimum of 3 months Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50 Exclusion Criteria: Bilateral headaches Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) History of whiplash injury within the last 6 weeks Diagnosis of cervical spinal stenosis Bilateral upper extremity symptoms Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes) Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: Muscle weakness involving a major muscle group of the upper extremity. Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors Diminished or absent sensation to pinprick in any upper extremity dermatome Prior surgery to the neck or thoracic spine. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches. Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination. Any condition that might contraindicate spinal manipulative therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrust manipulation<br> | Other: Thrust Manipulation<br>* Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.<br>* Other names: High-velocity low-amplitude thrust manipulation of the spine;|
| Active Comparator: Non-thrust mobilization and exercise<br> | Other: Non-thrust Mobilization and Exercise<br>* Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.<br>* Other names: Cervical range of motion, strength, and postural exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Frequency | The number of headache days in the past week (as registered in headache diary) | Baseline | 
| Headache Frequency | The number of headache days in the past week (as registered in headache diary) | 1-week | 
| Headache Frequency | The number of headache days in the past week (as registered in headache diary) | 4-weeks | 
| Headache Frequency | The number of headache days in the past week (as registered in headache diary) | 3-months | 
| Headache Intensity | Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week. | Baseline | 
| Headache Intensity | Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week. | 1-week | 
| Headache Intensity | Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week. | 4-weeks | 
| Headache Intensity | Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week. | 3-months | 
| Headache Duration | Average number of headache hours in the last week (as registered in the headache diary) | Baseline | 
| Headache Duration | Average number of headache hours in the last week (as registered in the headache diary) | 1-week | 
| Headache Duration | Average number of headache hours in the last week (as registered in the headache diary) | 4-weeks | 
| Headache Duration | Average number of headache hours in the last week (as registered in the headache diary) | 3-months | 
| Neck Disability Index (NDI) | Neck pain and disability | Baseline | 
| Neck Disability Index (NDI) | Neck pain and disability | 1-week | 
| Neck Disability Index (NDI) | Neck pain and disability | 4-weeks | 
| Neck Disability Index (NDI) | Neck pain and disability | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change (GROC) | Perceived improvement. | 1-week | 
| Global Rating of Change (GROC) | Perceived improvement. | 4-weeks | 
| Global Rating of Change (GROC) | Perceived improvement. | 3-months | 
| Analgesic Use | Analgesic (medication intake) use per day (as registered in the headache diary). | Baseline | 
| Analgesic Use | Analgesic (medication intake) use per day (as registered in the headache diary). | 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise