What side effects are associated with this type of intervention?

Common treatments for Cervicogenic Headache, such as Osteopathic Manipulative Treatment (OMT) and Targeted Head Exercise (THE), generally have mild side effects. These may include temporary soreness, muscle stiffness, and mild discomfort at the treatment site. In rare cases, patients might experience headaches, fatigue, or dizziness following the sessions. Overall, these treatments are considered safe with a low risk of serious adverse effects.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments directly targeting Cervicogenic Headache through methods similar to Osteopathic Manipulative Treatment (OMT) and Targeted Head Exercise (THE). Generally, treatments for cervicogenic headaches may include physical therapy, manual therapy, and exercises aimed at improving muscle function and reducing pain. While these approaches are commonly used, they do not typically require FDA approval as they are non-pharmacologic interventions. For pharmacologic treatments, medications such as NSAIDs, muscle relaxants, and nerve blocks may be used, but these are not specific to the muscle pathology addressed by OMT and THE.

What other types of research exist?

Promising novel alternatives to OMT and THE for cervicogenic headache patients in 2024 may include advanced neuromodulation techniques such as transcutaneous electrical nerve stimulation (TENS) and non-invasive vagus nerve stimulation (nVNS), innovative pharmacologic therapies targeting specific pain pathways, and emerging physical therapy modalities like virtual reality-based rehabilitation and biofeedback training.

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Behavioural Intervention

Combined Osteopathic and Exercise Therapy for Cervicogenic Headache (CGH Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females diagnosed with chronic cervicogenic headache.

Be older than 18 years old

Must not 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.

History of spinal surgery performed on the neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

This trial tests a combination of hands-on therapy and specific exercises to treat chronic headaches caused by neck problems. It focuses on women aged 18 to 75 who suffer from these headaches. The treatment aims to improve neck muscle health, which is expected to reduce headache pain, frequency, and duration.

Who is the study for?

This trial is for women aged 18-75 with chronic cervicogenic headache, which is a type of headache originating from the neck. Participants should not have been in a rear-end car accident within the last 3 years, had neck surgery, or suffer from certain diseases like rheumatoid arthritis or lupus.

What is being tested?

The study tests if Osteopathic Manipulative Therapy (OMT) combined with targeted head exercises can reduce headache frequency, intensity, and duration compared to standard medical care alone. It's a randomized controlled trial focusing on muscle pathology related to headaches.

What are the potential side effects?

While specific side effects are not listed here, OMT and exercise therapy may typically include soreness or discomfort in treated areas. Any unexpected side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman diagnosed with chronic headaches originating from the neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe brain or spinal issues, balance problems, or am not pregnant.

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I have had surgery on my neck.

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I have been diagnosed with rheumatoid arthritis, lupus, or ankylosing spondylitis.

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I have a pinched nerve in my neck causing arm pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cervicogenic Headache

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Osteopathic Manipulative Treatment (OMT) and Targeted Head Exercise (THE) are common treatments for Cervicogenic Headache (CeH) that focus on improving musculoskeletal function and reducing referred headache pain. OMT uses manual techniques to correct dysfunctions in the cervical spine and surrounding tissues, while THE involves specific exercises to strengthen and restore normal function to the rectus capitis posterior minor (RCPm) muscles. These treatments are important for CeH patients as they address muscle pathology and improve muscle function, thereby targeting the underlying causes of their headache symptoms.