Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache

Study Overview
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Brief Summary
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The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed Description
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Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group

Official Title
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Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial

Conditions
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Cervicogenic Headaches

Intervention / Treatment
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* Other: Dry Needling,Thrust Manipulation
* Other: Exercise,Non-thrust Mobilization


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: 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. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc. History of whiplash injury within the last 6 weeks Diagnosis of cervical stenosis Bilateral upper extremity symptoms Evidence of CNS 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, 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 2 of the following: Muscle weakness involving a major muscle group of the upper extremity. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors Diminished or absent sensation to pinprick in any UE dermatome. Prior surgery to neck of thoracic spine Involvement in litigation or worker's compensation regarding their neck pain and/or headaches PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam. 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: Dry Needling,Thrust Manipulation<br> | Other: Dry Needling,Thrust Manipulation<br>* HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.<br>* Other names: Dry Needling;|
| Active Comparator: Exercise,Non-thrust Mobilization<br> | Other: Exercise,Non-thrust Mobilization<br>* Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.<br>* Other names: Non-thrust Mobilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Headache Intensity (NPRS) (Rating Score) | Rating Score. Baseline score must exceed 2/10 to be included in the study. | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Headache Frequency (Number of headaches in the last week) | Number of headaches in the last week | Baseline, 1 week, 4 weeks, 3 months | 
| Change in Disability (NDI 0-50 points) | 10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study. | Baseline, 1 week, 4 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Rating of Change Score |  | 1 week, 4 weeks, 3 months | 
| Change in Medication Intake (Frequency of medication intake in last week) |  | Baseline, 3 months | 
| Change in Headache Duration (Total hours of headaches in the last week) | Total hours of headaches in the last week | Baseline, 1 week, 4 weeks, 3 months |