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NCT05617365 · ClinicalTrials.gov registry record · Phase 1

Treating Chronic Cervicogenic Head and Neck Pain

A Phase 1 study of Cervicogenic Headache and Neck Pain, Posterior, sponsored by Michigan State University.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT05617365: Recruiting Phase 1 study of Cervicogenic Headache and Neck Pain, Posterior, sponsored by Michigan State University.

NCT05617365 is a Phase 1 study of Cervicogenic Headache and Neck Pain, Posterior that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 30 participants, below the 63-participant average among 4 other Cervicogenic Headache trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05617365, a Phase 1 study of Cervicogenic Headache and Neck Pain, Posterior, is actively recruiting participants, sponsored by Michigan State University.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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 th

Primary Outcome

Reduction of headache frequency

Interventions

  • COMBINATION_PRODUCT Osteopathic Manipulative Therapy and Exercise Therapy

Study Locations (1)

Michigan

  • Michigan State University - East Lansing

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-09-01
Est. Completion 2026-06-01
Phase Phase 1
Michigan State University

120 total trials

What NCT05617365 shows while recruiting

NCT05617365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 63-participant average among 4 other Cervicogenic Headache trials with a reported enrollment target (52% lower).

The record links to 2 conditions, with Cervicogenic Headache appearing as the primary indexed condition, and to 1 intervention - of which Osteopathic Manipulative Therapy and Exercise Therapy is the first listed.

NCT05617365 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT05617365 about?

NCT05617365 is a clinical study titled "Treating Chronic Cervicogenic Head and Neck Pain". 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 paralle...

What is the current status of trial NCT05617365?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-09-01. Estimated completion is 2026-06-01.

What conditions does trial NCT05617365 study?

This clinical trial studies the following conditions: Cervicogenic Headache, Neck Pain, Posterior.

What interventions are being tested in trial NCT05617365?

The interventions under investigation include: Osteopathic Manipulative Therapy and Exercise Therapy (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05617365?

This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05617365 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05617365, the US trial registry maintained by the National Library of Medicine. NCT05617365 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.