Combined Osteopathic and Exercise Therapy for Cervicogenic Headache

(CGH Trial)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Michigan State University

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Combined Osteopathic and Exercise Therapy for Cervicogenic Headache?

Research suggests that physical therapy, which includes exercise, is more effective than massage or acupuncture for tension-type headaches and may benefit those with frequent headaches. Osteopathic manipulative treatment (OMT) is also used for managing headache pain, though more high-quality studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

Is the combined osteopathic and exercise therapy safe for humans?

Research on osteopathic manipulative treatment (OMT) suggests it is generally safe for humans, with studies indicating it is a non-invasive option for managing headaches and other conditions. However, more high-quality studies are needed to fully understand its safety profile. ^{2 4 6 7 8}

How is the combined osteopathic and exercise therapy treatment for cervicogenic headache different from other treatments?

This treatment is unique because it combines osteopathic manipulative therapy (hands-on techniques to improve body function) with targeted exercise therapy, offering a non-drug approach that may address both the physical and functional aspects of cervicogenic headaches, unlike standard pharmacological treatments which often have limited effects. ^{4 5 8 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Osteopathic Manipulative Therapy and Exercise Therapy (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Doug Gage

Michigan State University

Chief Executive Officer

PhD in Botany from the University of Texas

David Smith

Michigan State University

Chief Medical Officer

MD from Michigan State University

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Noninvasive treatments for headache. [2009]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Osteopathy for primary headache patients: a systematic review. [2020]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. [2016]

5. England 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Spinal manipulation for the management of cervicogenic headache: A systematic review and meta-analysis. [2021]

10. England 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. [2023]