Treating Chronic Cervicogenic Head and Neck Pain
CompletedPhase 1, Phase 2NCT05617365
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 …
Study details
- Official title
- Treating Chronic Cervicogenic Head and Neck Pain With Osteopathic Manipulation and Exercise Therapy
- Conditions
- Cervicogenic Headache
- Neck Pain, Posterior
- Interventions
- Combination product: Osteopathic Manipulative Therapy and Exercise Therapy
- Sponsor
- Michigan State University
- Start date
- 2022-09-01
- Primary completion
- 2025-04-07
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05617365