Treating Chronic Cervicogenic Head and Neck Pain

NCT05617365 | Recruiting Phase 1

• 1 other identifier: 016507-00001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache; Neck Pain, Posterior

Outcome Measures

Primary Outcomes (1)

• Cervicogenic Headache

  Reduction of headache frequency

  18 months

Study Arms (2)

Treatment

EXPERIMENTAL

All subjects in the Treatment group will receive OMT a minimum 4 times and a maximum of 8 times at the physician's (JJR) discretion (Jull et al., 2002). All subjects in the Treatment group will be taught the THE. This voluntary head retraction/protrusion exercise protocol engages the RCPm muscles in eccentric and isometric contractions that should strengthen the muscles and thereby increase CSA.

Combination Product: Osteopathic Manipulative Therapy and Exercise Therapy

Control

NO INTERVENTION

All subjects assigned to the Control group will be allowed to continue to receive conservative care. It is understood that any care that they receive will be prescribed on an individual basis. A participant could therefore receive any combination of medical, physio therapeutic and psychological care. It would also be expected that some form of pain management will be a priority for participants with moderate to severe symptoms. Subjects assigned to the Control group will not receive OMT and will not be taught the THE protocol.

Interventions

Osteopathic Manipulative Therapy and Exercise Therapy COMBINATION_PRODUCT

At the physician's discretion, each subject will receive a minimum of 4 treatments up to a maximum of 8 treatments over the 12-week duration of the study (Haas et. al., 2018). The patients may be treated in the seated, prone and/or supine positions. Duration of treatment will depend on the degree of documented dysfunction but will be limited to one half hour. The techniques utilized by the physician may vary for many reasons including the degree of restriction, acuity, or patient cooperation. The THE protocol will involve subjects performing cyclic voluntary retraction and protrusion of their head.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Neck Pain

Interventions

Manipulation, Osteopathic; Exercise Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Richard C Hallgren, PhD

CONTACT

517-256-7631; hallgren@msu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The primary aim of our study is to test the combined effectiveness of osteopathic manipulative treatment (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.

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 15, 2022
• Study Start: September 1, 2022
• Primary Completion: April 7, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1)