Cervicogenic Headache Clinical Trial
— CGHOfficial title:
Treating Chronic Cervicogenic Head and Neck Pain With Osteopathic Manipulation and Exercise Therapy
The primary aim is to test the combined effectiveness of OMT and targeted head exercise (THE) to achieve a significant decrease in headache measures of frequency, intensity, and duration in a Treatment group when compared to a Control group whose members receive only standard medical care. A parallel, 2-arm, longitudinal, randomized controlled trial (RCT) will focus upon female patients (18 to 75 years of age) who have been diagnosed with chronic cervicogenic headache (CeH) based upon a differential diagnosis that includes classification according to the International Headache Society Classification IHSD 3rd Edition, reproduction of referred headache resulting from manual pressure over the upper cervical regions, and objective MRI findings. It is estimated that a sample size of 30 will provide sufficient statistical power (79%) to detect an intervention effect that corresponds to a clinically meaningful recovery (60%). CeH is classified as a secondary headache disorder because the headache pain is a consequence of injury to, or disease of, the bony and/or soft tissues of the upper cervical spine. It has been reported that some patients diagnosed with CeH demonstrate atrophy and/or fatty infiltration (FI) of the RCPm muscles on MRI. FI and/or a reduction in the cross-sectional area (CSA) of active muscle would not be expected to be the direct cause of chronic headache, but either or both could prevent muscles from generating normal physiologic levels of force. It has been shown that there is a functional connection between the pain sensitive dura mater and RCPm muscles and it is known that mechanical stretching of the dura mater results in referred headache. While FI and/or a reduction in the CSA of active muscle would not be expected to be the direct cause of chronic headache, it is known that muscle pathology will result in functional deficits. It is proposed that pathology in RCPm muscles will compromise the normal functional relationship between the RCPm and the dura mater and result in referred head and neck pain. It is predicted that at the end of the study, the Treatment group will show a significant decrease in headache measures that will be accompanied by a significant increase in CSA and a significant decrease in FI on MRI, and restoration of a normal head posture that will not be seen in the Control group. The proposed study is unique in that we are proposing both a mechanism and a source for some instances of CeH. By testing the effectiveness of specific interventions to address a specific pathology within a specific headache population, and by restricting the study cohort to female subjects presenting with CeH, this study will increase the ability to detect a significant change in the outcomes by increasing the power of the statistical analysis.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2026 |
Est. primary completion date | January 29, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Females diagnosed with chronic cervicogenic headache. Exclusion Criteria: - Have you been involved in a rear-end motor vehicle accident within the past 3 years? - Have you had spinal surgery performed on your neck? - Do you have a pinched nerve in the neck that produces pain radiating down your arm. - Have you been diagnosed with diseases such as rheumatoid arthritis, lupus, or ankylosing spondylitis. - Do you have ongoing central nervous system pathology such as hemiparesis, cervical radiculopathy, spondylolisthesis grade III or IV, central nervous system causes of balance & coordination deficits, orthostatic hypotension, vestibular disorders, pregnancy, recent spinal fractures, moderate to severe traumatic brain injury. |
Country | Name | City | State |
---|---|---|---|
United States | Michigan State University | East Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cervicogenic Headache | Reduction of headache frequency | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05545423 -
Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache
|
N/A | |
Not yet recruiting |
NCT05289414 -
Radiofrquency Targeting Mid Cervical Medial Branches vs GON in Cervicogenic Headache
|
Phase 2/Phase 3 | |
Completed |
NCT01687881 -
Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
|
N/A | |
Recruiting |
NCT05491915 -
The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
|
N/A | |
Active, not recruiting |
NCT02908984 -
Specific Neck Rehabilitation for Unilateral Headache and Neck Pain, and Structural and Functional Changes in the Brain
|
N/A | |
Completed |
NCT01790074 -
Trigger Point Therapy in Cervicogenic Headache
|
N/A | |
Terminated |
NCT03730896 -
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
|
N/A | |
Completed |
NCT05582616 -
The Safety and Feasibility of tDCS Combined With Conservative Treatment for Cervicogenic Headaches
|
N/A | |
Recruiting |
NCT06459726 -
Effects of Shi Style Cervical Mobilization Versus SNAGS in Patients With Cervicogenic Headache
|
N/A | |
Completed |
NCT04521218 -
Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) in Cervicogenic Headache
|
N/A | |
Completed |
NCT00184197 -
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
|
Phase 2 | |
Completed |
NCT04625387 -
Dry Needle In Management of Cervicogenic Headache
|
N/A | |
Completed |
NCT05865808 -
Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache.
|
N/A | |
Completed |
NCT05827185 -
Effects of Workstation Ergonomics and Physiotherapy in Cervicogenic Headache.
|
Phase 2 | |
Completed |
NCT04454541 -
Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache
|
N/A | |
Completed |
NCT03919630 -
Mobilization Versus Manipulation for the Treatment of Cervicogenic Headaches
|
N/A | |
Completed |
NCT04242290 -
Cervicospinal Posture and Pain in Cervicogenic Headache
|
||
Completed |
NCT05754931 -
Deep Neck Flexors Training Versus Muscle Energy Technique on Cervicogenic Headache
|
N/A | |
Completed |
NCT05849545 -
Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache
|
N/A | |
Recruiting |
NCT05312645 -
Diclofenac Gel in the Treatment of Cervicogenic Headache
|
Phase 3 |