NCT05617365 Treating Chronic Cervicogenic Head and Neck Pain
| NCT ID | NCT05617365 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Michigan State University |
| Condition | Cervicogenic Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-04-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2022-09-01 with a primary completion date of 2025-04-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05617365 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Cervicogenic Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05617365 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05617365 currently recruiting?
Yes, NCT05617365 is actively recruiting participants. Contact the research team at hallgren@msu.edu for enrollment information.
Where is the NCT05617365 trial being conducted?
This trial is being conducted at East Lansing, United States.
Who is sponsoring the NCT05617365 clinical trial?
NCT05617365 is sponsored by Michigan State University. The trial plans to enroll 30 participants.