NCT05617365: CGH

Treating Chronic Cervicogenic Head and Neck Pain

Recruiting now Phase 1, PHASE2 Last updated 18 September 2025

What this trial tests

Phase 1, PHASE2 trial testing Osteopathic Manipulative Therapy and Exercise Therapy in Cervicogenic Headache in 30 participants. Currently enrolling.

Timeline

1 September 2022

Primary endpoint
7 April 2025

1 June 2026

Quick facts

Lead sponsor	Michigan State University
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 September 2022
Primary completion	7 April 2025
Estimated completion	1 June 2026
Sites	1 location across United States

Drugs / interventions tested

• Osteopathic Manipulative Therapy and Exercise Therapy

Conditions studied

• Cervicogenic Headache — all drugs for Cervicogenic Headache →
• Neck Pain, Posterior — all drugs for Neck Pain, Posterior →

Sponsor

Michigan State University

Who can join

Adults 18 to 65, female only, with Cervicogenic Headache or Neck Pain, Posterior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.