Combined Osteopathic and Exercise Therapy for Cervicogenic Headache

(CGH Trial)

Overseen By Richard C Hallgren, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Michigan State University

Disqualifiers: Recent car accident, Spinal surgery, Pinched nerve, Rheumatoid arthritis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 18 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combining osteopathic therapy with special exercises to reduce cervicogenic headaches, which stem from neck issues. Participants in the treatment group will receive osteopathic manipulative therapy and learn exercises to strengthen neck muscles, while the control group will continue their usual care. The researchers aim to determine if the treatment group experiences fewer, less intense, or shorter headaches than the control group. Women diagnosed with chronic cervicogenic headache, who have not had recent neck surgery or certain other conditions, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that osteopathic manipulative therapy (OMT) and exercise therapy are generally safe. Studies indicate that OMT, a gentle, hands-on method, often helps with headaches. Evidence supports the safety of these manual therapies, which include techniques to relax neck muscles. These therapies are usually well-tolerated and carry a low risk of serious side effects.

Moreover, OMT does not involve drugs, avoiding the side effects that medications can sometimes cause. This makes it an appealing choice for those seeking alternative headache treatments. Overall, research suggests that these therapies are safe and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Osteopathic Manipulative Therapy (OMT) and Exercise Therapy for cervicogenic headaches because this approach offers a unique, non-invasive alternative to standard treatments like medications and physical therapy alone. OMT targets the root cause by using hands-on techniques to improve joint function and relieve muscle tension, potentially reducing headache triggers. Meanwhile, the tailored exercise protocol strengthens specific neck muscles, which can prevent headaches from occurring. This dual-action method not only addresses immediate pain relief but also aims to reduce headache frequency and severity over time, setting it apart from typical pain management strategies.

What evidence suggests that this trial's treatments could be effective for cervicogenic headache?

This trial will compare the effects of osteopathic manipulative therapy (OMT) combined with exercise therapy to a control group receiving standard conservative care for cervicogenic headaches. Research has shown that certain therapies, like OMT and exercise therapy, may help treat cervicogenic headaches. Manual therapies, such as OMT, have proven effective for some types of headaches, suggesting they might also help with cervicogenic headaches. Early studies indicated that OMT and exercises focusing on specific neck muscles can lessen headache symptoms by improving muscle function and reducing fat in the muscles. These therapies aim to strengthen neck muscles, potentially relieving headache-related pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

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

I have had surgery on my neck.

You were in a car accident where another car hit you from behind in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the Treatment group receive Osteopathic Manipulative Treatment (OMT) and are taught targeted head exercises (THE). Control group receives standard medical care.

18 months

4 to 8 visits (in-person) for the Treatment group

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on headache frequency, intensity, and duration.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Therapy and Exercise Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 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: Control Active Control 1 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.

Osteopathic Manipulative Therapy and Exercise Therapy is already approved in United States, European Union for the following indications:

Approved in United States as OMT for:

• Chronic cervicogenic headache
• Neck pain

Approved in European Union as Osteopathic Manipulative Treatment for:

• Headache disorders
• Musculoskeletal conditions

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Published Research Related to This Trial

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

Osteopathic manipulative treatment (OMT) is a safe and effective non-invasive option for headache sufferers, particularly for those who prefer to avoid pharmaceuticals or have contraindications to them.

OMT has shown benefits for various headache types, including migraines and tension-type headaches, making it a versatile treatment option tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. Whalen, J., Yao, S., Leder, A.[2019]

Chiropractic spinal manipulative therapy significantly improved headache frequency and headache index in participants with cervicogenic headache compared to a control group, while the placebo group also showed some improvement at later follow-ups.

The study indicated that chiropractic therapy is a safe treatment option, with only a few mild and transient adverse events reported, but further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. Chaibi, A., Knackstedt, H., Tuchin, PJ., et al.[2019]

Spinal manipulative therapy (SMT) shows small but significant short-term benefits in reducing pain intensity, frequency, and disability in patients with cervicogenic headache (CGHA), based on a review of seven randomized controlled trials.

However, the long-term effects of SMT on CGHA are not significant, and the overall quality of evidence in this area is considered low, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal manipulation for the management of cervicogenic headache: A systematic review and meta-analysis. Fernandez, M., Moore, C., Tan, J., et al.[2021]

Manual and exercise therapy, particularly spinal manipulation, may effectively reduce headache intensity, frequency, and disability in individuals with cervicogenic headache, based on a systematic review of 20 studies involving 1439 patients.

While the overall quality of evidence was moderate, a sensitivity analysis of low-risk of bias trials indicated that spinal manipulation showed moderate-quality evidence for its effectiveness compared to sham treatments, highlighting the need for more rigorous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of manual and exercise therapy on headache intensity and frequency among patients with cervicogenic headache: a systematic review and meta-analysis. Bini, P., Hohenschurz-Schmidt, D., Masullo, V., et al.[2023]

In a pilot study involving 44 patients with frequent episodic tension-type headaches, osteopathic manipulative therapy (OMTh) significantly reduced headache frequency by approximately 40% after one month and 50% after three months compared to sham therapy.

The results suggest that OMTh may be a preferred treatment option for patients who experience side effects from medications or have trouble adhering to pharmacological treatments, highlighting its potential as an effective non-drug intervention for headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. Rolle, G., Tremolizzo, L., Somalvico, F., et al.[2016]

Osteopathic manipulative treatment (OMT) may help reduce the frequency of migraine episodes and decrease the need for medication, based on a review of five studies focused on headache management.

The evidence supporting OMT's effectiveness is currently low due to the presence of bias in the studies reviewed, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathy for primary headache patients: a systematic review. Cerritelli, F., Lacorte, E., Ruffini, N., et al.[2020]

This study will evaluate the effectiveness of Mulligan Manual Therapy (MMT) combined with exercise in managing migraine, tension-type headache (TTH), and cervicogenic headache (CGH) in a randomized controlled trial involving 297 participants.

The primary outcome will focus on headache frequency, with secondary measures including headache duration, intensity, and disability, providing a comprehensive assessment of MMT's impact compared to placebo and exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. Satpute, K., Bedekar, N., Hall, T.[2021]

Physical therapy is more effective than massage therapy or acupuncture for treating tension-type headaches, especially in patients with frequent headache attacks.

Chiropractic manipulation may offer some benefit for tension-type headaches, but the evidence is weak, and physical treatments generally carry low risk except for high-velocity neck manipulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive treatments for headache. Biondi, DM.[2009]

In a study of 110 participants with cervicogenic headache, those who received cervical and thoracic manipulation showed significantly greater reductions in headache intensity and disability compared to those who underwent mobilization and exercise, with effects lasting up to 3 months.

The manipulation group also reported fewer headaches and shorter headache durations at all follow-up points, indicating that this treatment may be more effective for long-term relief of cervicogenic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. Dunning, JR., Butts, R., Mourad, F., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11377354/

A Review on Osteopathic Manipulation in Patients With ...

... manipulation for patients with cervicogenic headaches. Over time ... Efficacy of manual therapy in the treatment of tension-type headache.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S174606890500057X

Case study Effectiveness of cervical spine manipulation ...

The wide range of treatment approaches for cervicogenic headache suggests that no single effective therapy has been identified, although manual and manipulative ...

3.

withpower.com

withpower.com/trial/phase-2-posterior-neck-pain-8-2022-2f4d1

Combined Osteopathic and Exercise Therapy for ...

Chiropractic spinal manipulative therapy significantly improved headache frequency and headache index in participants with cervicogenic headache compared to a ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9462953/

Osteopathic Manipulative Treatment and the Management of ...

... targeted the effects of manual manipulation in the treatment of headaches. Among the reviews, two specific headaches were primarily focused ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04976985

Osteopathic Manipulative Treatment and Migraine ...

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12123087/

Comparative safety and efficacy of manual therapy ...

Moderate-quality evidence supports the use of manual therapies (e.g., cervical muscle relaxation techniques, spinal manipulation), targeted ...

7.

withpower.com

withpower.com/trial/phase-2-posterior-neck-pain-8-2022-2f4d1?fbclid=IwZXh0bgNhZW0CMTEAAR7iEhbHnz4h51aTc3CeBVzpH9y55ZHqPisU6OXibLPLsI9mrJmOMdlYzO5iLg_aem_HrU7acwMJT13k-60n6umSQ

Combined Osteopathic and Exercise Therapy for ...

Research on osteopathic manipulative treatment (OMT) suggests it is generally safe for humans, with studies indicating it is a non-invasive option for managing ...

8.

osteopathic.org

osteopathic.org/wp-content/uploads/policies/Policy_H324-A-19_Osteopathic_Manipulative_Treatment_of_the_Cervical_Spine-2.pdf

Osteopathic Manipulative Treatment (OMT) of the Cervical ...

How dangerous is manipulation to the cervical spine? Case report and results of a survey. Manual Medicine, 2, 1-4. 22. Carey P.F. (1993). A ...