Combined Osteopathic and Exercise Therapy for Cervicogenic Headache
(CGH Trial)
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
24678How 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.
458910Eligibility 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.
+2 more
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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michigan State UniversityEast Lansing, MI
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Who Is Running the Clinical Trial?
Michigan State UniversityLead Sponsor
References
Noninvasive treatments for headache. [2009]Primary headache disorders are often accompanied by neck pain or other symptoms referable to neck muscles. Therefore, physical therapy and other physical treatments are commonly prescribed for headache management. A medical literature review was completed in order to gather information regarding the efficacy of selected physical modalities in the treatment of primary and cervicogenic headache disorders. After analyzing the collected data, expert opinions were developed regarding the utility and efficacy of selected physical modalities in the management of primary and cervicogenic headaches. Based on this review, the following four expert opinions are presented: physical therapy is more effective than massage therapy or acupuncture for the treatment of tension-type headache and appears to be most beneficial for patients with a high frequency of headache attacks. Physical therapy is most effective for the treatment of migraine when combined with other treatments such as thermal biofeedback, relaxation training and exercise. Chiropractic manipulation demonstrated a trend towards benefit in the treatment of tension-type headache, but evidence is weak. Chiropractic manipulation is probably more effective in the treatment of tension-type headache than it is in the treatment of migraine. In general, strong evidence is lacking regarding the efficacy of these treatments in reducing headache frequency, intensity, duration and disability in many commonly encountered clinical situations. Many of the published case series and controlled studies are of low quality. Physical treatments are unlikely to pose a significant risk, with the exception of high velocity chiropractic manipulation of the neck. Consideration must be given to financial costs and lost treatment opportunity by prescribing potentially ineffective treatment. In the absence of clear evidence regarding their role in treatment, physicians and patients are advised to make cautious and individualized judgments about the utility of physical treatments for headache management. In most cases, the use of physical modalities should complement rather than replace better validated forms of therapy. The evidence base to determine the safety and efficacy of physical treatments in the management of headache disorders would be substantially improved by using standard scientific rigor in the development and conduct of future clinical studies.
Osteopathy for primary headache patients: a systematic review. [2020]This systematic review aimed to assess the efficacy, effectiveness, safety, and tolerability of osteopathic manipulative treatment (OMT) in patients with headache.
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]Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH.
Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. [2016]Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) may be used for managing headache pain and related disability, but there is a need for high-quality randomized controlled trials to assess the effectiveness of this intervention.
Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. [2018]Although commonly utilized interventions, no studies have directly compared the effectiveness of cervical and thoracic manipulation to mobilization and exercise in individuals with cervicogenic headache (CH). The purpose of this study was to compare the effects of manipulation to mobilization and exercise in individuals with CH.
Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions.
A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. [2019]This review highlights the importance of osteopathic manipulative treatment (OMT) in headache sufferers. OMT is a viable option for patients who either do not wish to use pharmaceuticals or who have contraindications to pharmaceuticals. Patients with headaches that are refractory to other treatment options may also be candidates for OMT. Multiple headache etiologies are amenable to this non-invasive treatment option and they will be reviewed here. Although there are advantages to using this treatment method, there are also shortcomings in the literature, which will be discussed.
Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. [2019]Cervicogenic headache is a disabling headache where pharmacological management have limited effect. Thus, non-pharmacological management is warranted. Our objective was therefore to investigate the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continued usual but non-manual management) for cervicogenic headache in a prospective 3-armed single-blinded, placebo, randomized controlled trial of 17 months' duration.
Spinal manipulation for the management of cervicogenic headache: A systematic review and meta-analysis. [2021]Spinal manipulative therapy (SMT) is frequently used to manage cervicogenic headache (CGHA). No meta-analysis has investigated the effectiveness of SMT exclusively for CGHA.
The effectiveness of manual and exercise therapy on headache intensity and frequency among patients with cervicogenic headache: a systematic review and meta-analysis. [2023]Cervicogenic headache is a secondary headache, and manual therapy is one of the most common treatment choices for this and other types of headache. Nonetheless, recent guidelines on the management of cervicogenic headache underlined the lack of trials comparing manual and exercise therapy to sham or no-treatment controls. The main objective of this systematic review and meta-analysis was to assess the effectiveness of different forms of manual and exercise therapy in people living with cervicogenic headache, when compared to other treatments, sham, or no treatment controls.