Chronic Migraine, HeadacheSMART-CMNCT04520425
Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
A study testing Osteopathic manipulative therapy in people with Chronic Migraine, Headache, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteopathic manipulative therapy trials, the acceptability of this specific treatment to patients, and evaluate its… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine, Headache
- What is being tested?
- Osteopathic manipulative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in this study patients must be:
- An adult ≥ 18 years of age and ≤ 60 years of age
- Enrolled for care at Penn State Hershey Family and Community Medicine as demonstrated by at least one primary care visit within the past 3 years
- Diagnosed with chronic migraine (as defined by the International Headache Society: "Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache"
- Legally and physically able to consent in English
- Willing and able to complete seven in-person visits, each approximately 30 minutes in length, over the course of 21 weeks.
Who cannot join
- Patients will be ineligible to participate in this study if they:
- Are diagnosed with secondary headache
- Are pregnant (as reported at the time of enrollment; no pregnancy test is required; patients who become pregnant during the study will be withdrawn from the study. (However, they may continue to receive non-study related OMT treatments through their primary care provider as OMT has been shown to be safe in pregnancy.))
- Are less than 18 or more than 60 years of age
- Are diagnosed with fibromyalgia.
- Have current or prior migraine or other headache treatment with onabotulinumtoxinA (Botox®)
Show all 15Show fewer
- Have received any treatment of neck or head with onabotulinumtoxinA (Botox®) within the past year
- Have current or prior (within 12 months) treatment for any condition with Topiramate
- Are determined by the physician administering OMT to have a medical condition, history, or medication that is likely to decrease the efficacy or increase the risk of OMT. Not all patients with the following conditions will be excluded, but some patients with any of the following may be determined to be unlikely to benefit from OMT or at increased risk of OMT, and will be excluded.
- A history of surgery in the head or neck (except for: uncomplicated dental surgery that is more than 2 years prior and required no significant implantation (i.e., routine wisdom tooth extraction, braces, or root canal))
- Unstable mental health disorders
- Chronic chronic inflammatory disorders, severe osteoporosis, tumors, evidence of central nervous system pathology include facial palsy, abnormality in vision, speech or balance, paresthesia, or weakness
- Have had previous osteopathic treatment for migraine or other headache
- Have current or past substance abuse disorder
- Have current or pending disability payments, applications for disability or litigation for disability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteopathic manipulative therapy trials, the acceptability of this specific treatment to patients, and evaluate its preliminary effectiveness.
Read the detailed description
In the United States, 12% of adults suffer from migraines. Migraines are categorized as episodic or chronic (CM). CM is less common than episodic, with a prevalence of 2%, but far more debilitating, with three times the annual per capita cost, putting the total U.S. direct and indirect cost estimate of CM at $15.5 billion dollars per year. Compared to patients with episodic migraine, those with CM have a lower quality of life (QoL) and higher utilization of primary and emergency care. CM has only two prophylactic pharmacologic treatment options with efficacy demonstrated through randomized, placebo-controlled trials. One is Topiramate, whose side effects, including fatigue, dizziness, mood changes and suicidal ideation, can compromise patients' QoL and adherence rate to this treatment, which has been estimated as under 25%. The other is onabotulinumtoxinA, whose side effects, including neck pain, eyelid ptosis and worsening headaches, are reported in over 25% of users. Due to these high frequency, debilitating side effects, ¬there is an urgent need to develop effective CM treatments with low side-effect profiles.
Osteopathic manipulative treatment (OMT) has been reported to improve episodic and CM symptoms without major side effects. Improvements with OMT include decreased Headache Impact Test (HIT-6) scores, fewer headache days per month and decreased medication use. While promising, these studies have significant limitations, such as small sample sizes and high risk of bias. Further, even higher quality OMT studies rely on the treating physician to select from among several OMT treatment techniques, rather than using a standardized treatment procedure. Together, these limitations led the most recent literature assessment to conclude that, "more study is needed before manipulative therapies can be confidently recommended to prevent and treat headaches." To overcome these limitations, OMT studies for the treatment of CM should apply rigorous methods, including standardized treatment procedures.
The investigators have developed a standardized OMT procedure to treat CM. The procedure is repeated every two weeks over a ten week period. Over the past five years it has been successfully used to treat 50 patients with CM in a single family physician's practice. Among the treated patients, 40 reported improved symptoms, and none reported adverse side effects. However, the procedure has not been formally evaluated using rigorous research methods.
The specific objectives of this pilot study are to evaluate the feasibility and acceptability of the standardized OMT procedure for CM, and gather preliminary data on its potential efficacy when implemented in a primary care setting. The central hypothesis is that the standardized myofascial release OMT procedure will improve symptoms of CM as measured by improvement in HIT-6, Migraine Disability Assessment (MIDAS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), and self-reported and electronic health record (EHR) medication usage and healthcare utilization. This hypothesis is supported by the investigators' anecdotal clinical success using this approach. The specific aims of this study are:
Aim 1: Assess the feasibility of systematically identifying and treating patients with the standardized OMT procedure within the Penn State Health medical system. Feasibility will be measured by the investigators' ability to identify and enroll CM patients in this study. The investigators will enroll 20-40 adult patients with CM who do not have common confounders. This data will inform the recruitment strategy of a future randomized clinical trial (RCT).
Aim 2: Assess the acceptability of the standardized OMT procedure. Acceptability will be measured by patient-reported satisfaction and perceived benefit, completion rate and adverse events or side-effects. This data will inform the sample size calculation of a future RCT.
Aim 3: Assess the preliminary effectiveness of the standardized OMT procedure. Efficacy will be measured by improvement in HIT-6, MIDAS, and MSQ scores; patient-reported headache frequency, medication usage, and healthcare utilization surveys; and medication and healthcare utilization documented in the EHR. This data will provide estimates of effect size to better inform the sample size calculation of a future RCT.
- Conditions
- Chronic Migraine, Headache
- Being tested
- Osteopathic manipulative therapy
- Keywords
- migraine, chronic migraine, osteopathic manipulative therapy
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative therapyProcedure or surgery
Also called OMT, myofascial release
- Mandibular: the clinician applies gentle pressure bilaterally to the subject's mandible, in the direction of the patient's clavicles.
- Frontal: the clinician applies gentle pressure bilaterally to the subject's forehead, in a direction halfway between the parietals and ears.
- Temporal: the clinician applies gentle pressure bilaterally to the subject's temples, in the direction of the patient's occiput.
- Parietal: the clinician applies gentle pressure bilaterally to the subject's parietal bones, in the direction of the patient's occipital atlanto joint.
- Occipital: the clinician applies gentle pressure to the subject's occipital bone, in the direction of the patient's neck.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive 5 standardized osteopathic manipulative treatments, two weeks apart. (To be considered a study completer, a participant must complete at least 3 of these treatments.) In addition to assessments at intake and during treatments, 1 and 3 months after their last treatment patients will be asked to provide follow-up data. Assessments include the HIT-6, MIDAS, and MSQ surveys, treatment satisfaction assessments, and a headache diary. Participants will also consent to an electronic medical record extraction of medication and healthcare services utilization. Receives: Procedure: Osteopathic manipulative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment metrics
Number of eligible patients identified through electronic medical record search, number of contacts needed to schedule an appointment, number of consent meetings to enroll a patient, number of patients who complete the study
Measured: 6 months
Treatment satisfaction, first treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment and likelihood of continuing treatments.
Measured: 1st treatment, week 12
Treatment satisfaction, second treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Measured: 2nd treatment, week 14
Treatment satisfaction, second treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Measured: 3rd treatment, week 16
Treatment satisfaction, second treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Measured: 4th treatment, week 18
Treatment satisfaction, second treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Measured: 5th treatment, week 20
Secondary outcomes (16)
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Measured: 1st treatment, week 12
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Measured: 1 month post-intervention, week 24
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Measured: 3 months post-intervention, week 36
MIDAS (Migraine Disability Assessment Test)
A validated method of measuring headache morbidity
Measured: 1st treatment, week 12
MIDAS (Migraine Disability Assessment Test)
A validated method of measuring headache morbidity
Measured: 3 months post-intervention, week 36
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Measured: 1st treatment, week 12
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Measured: 1 month post-intervention, week 24
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Measured: 3 months post-intervention, week 36
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 2nd treatment, week 14
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 3rd treatment, week 16
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 4th treatment, week 18
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 5th treatment, week 20
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 1 month post-intervention, week 24
Headache Diary
A validated self-assessment method of measuring headache morbidity
Measured: 3 months post-intervention, week 36
Medication Use
A measurement of total type and amount of medication used to manage migraines, obtained from patient reports on their Headache Diary and from the electronic medical record at the end of the study.
Measured: 3 months post-intervention from electronic health record, week 36
Healthcare Utilization
A measurement of the total type and number of healthcare visits as self reported in the Headache Diary and extracted from the electronic health record at the end of the study.
Measured: 3 months post-intervention from electronic health record, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start8 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Jun 2023
Why it stopped: Responsible Party left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consenting chronic migraine patients will receive 3-5 standardized osteopathic manipulative treatments over the course of ten weeks, and will be assessed for acceptance and efficacy of the treatment.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert P Lennon, MD, Principal investigator, Penn State Health Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520425
- Sponsor's protocol ID
- 00014287
- Acronym
- SMART-CM
- Status last verified
- Aug 2023
- First submitted
- 13 Aug 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Burch RC, Buse DC, Lipton RB. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019 Nov;37(4):631-649. doi: 10.1016/j.ncl.2019.06.001. Epub 2019 Aug 27.
PubMed 31563224Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Messali A, Sanderson JC, Blumenfeld AM, Goadsby PJ, Buse DC, Varon SF, Stokes M, Lipton RB. Direct and Indirect Costs of Chronic and Episodic Migraine in the United States: A Web-Based Survey. Headache. 2016 Feb;56(2):306-22. doi: 10.1111/head.12755. Epub 2016 Feb 1.
PubMed 26833083Bonafede M, Sapra S, Shah N, Tepper S, Cappell K, Desai P. Direct and Indirect Healthcare Resource Utilization and Costs Among Migraine Patients in the United States. Headache. 2018 May;58(5):700-714. doi: 10.1111/head.13275. Epub 2018 Feb 15.
PubMed 29446063Diener HC, Solbach K, Holle D, Gaul C. Integrated care for chronic migraine patients: epidemiology, burden, diagnosis and treatment options. Clin Med (Lond). 2015 Aug;15(4):344-50. doi: 10.7861/clinmedicine.15-4-344.
PubMed 26407383Silberstein SD. Topiramate in Migraine Prevention: A 2016 Perspective. Headache. 2017 Jan;57(1):165-178. doi: 10.1111/head.12997. Epub 2016 Nov 30.
PubMed 27902848Chiang CC, Starling AJ. OnabotulinumtoxinA in the treatment of patients with chronic migraine: clinical evidence and experience. Ther Adv Neurol Disord. 2017 Dec;10(12):397-406. doi: 10.1177/1756285617731521. Epub 2017 Sep 20.
PubMed 29204191Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.
PubMed 25847552Smith MS, Olivas J, Smith K. Manipulative Therapies: What Works. Am Fam Physician. 2019 Feb 15;99(4):248-252.
PubMed 30763049Chaibi A, Tuchin PJ, Russell MB. Manual therapies for migraine: a systematic review. J Headache Pain. 2011 Apr;12(2):127-33. doi: 10.1007/s10194-011-0296-6. Epub 2011 Feb 5.
PubMed 21298314Chaibi A, Benth JS, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):143-153. doi: 10.1111/ene.13166. Epub 2016 Oct 2.
PubMed 27696633Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.
PubMed 21385086Park PW, Dryer RD, Hegeman-Dingle R, Mardekian J, Zlateva G, Wolff GG, Lamerato LE. Cost Burden of Chronic Pain Patients in a Large Integrated Delivery System in the United States. Pain Pract. 2016 Nov;16(8):1001-1011. doi: 10.1111/papr.12357. Epub 2015 Oct 7.
PubMed 26443292GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.
PubMed 30353868Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med. 2002 May;112(7):566-71. doi: 10.1016/s0002-9343(02)01068-9.
PubMed 12015249
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
- ClinicalTrials.gov ID
- NCT04520425
- Acronym / sponsor ID
- SMART-CM / 00014287
- Conditions
- Chronic Migraine, Headache
- Keywords
- migraine, chronic migraine, osteopathic manipulative therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Responsible Party left institution
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteopathic manipulative therapy trials, the acceptability of this specific treatment to patients, and evaluate its preliminary effectiveness.
Detailed description
In the United States, 12% of adults suffer from migraines. Migraines are categorized as episodic or chronic (CM). CM is less common than episodic, with a prevalence of 2%, but far more debilitating, with three times the annual per capita cost, putting the total U.S. direct and indirect cost estimate of CM at $15.5 billion dollars per year. Compared to patients with episodic migraine, those with CM have a lower quality of life (QoL) and higher utilization of primary and emergency care. CM has only two prophylactic pharmacologic treatment options with efficacy demonstrated through randomized, placebo-controlled trials. One is Topiramate, whose side effects, including fatigue, dizziness, mood changes and suicidal ideation, can compromise patients' QoL and adherence rate to this treatment, which has been estimated as under 25%. The other is onabotulinumtoxinA, whose side effects, including neck pain, eyelid ptosis and worsening headaches, are reported in over 25% of users. Due to these high frequency, debilitating side effects, ¬there is an urgent need to develop effective CM treatments with low side-effect profiles.
Osteopathic manipulative treatment (OMT) has been reported to improve episodic and CM symptoms without major side effects. Improvements with OMT include decreased Headache Impact Test (HIT-6) scores, fewer headache days per month and decreased medication use. While promising, these studies have significant limitations, such as small sample sizes and high risk of bias. Further, even higher quality OMT studies rely on the treating physician to select from among several OMT treatment techniques, rather than using a standardized treatment procedure. Together, these limitations led the most recent literature assessment to conclude that, "more study is needed before manipulative therapies can be confidently recommended to prevent and treat headaches." To overcome these limitations, OMT studies for the treatment of CM should apply rigorous methods, including standardized treatment procedures.
The investigators have developed a standardized OMT procedure to treat CM. The procedure is repeated every two weeks over a ten week period. Over the past five years it has been successfully used to treat 50 patients with CM in a single family physician's practice. Among the treated patients, 40 reported improved symptoms, and none reported adverse side effects. However, the procedure has not been formally evaluated using rigorous research methods.
The specific objectives of this pilot study are to evaluate the feasibility and acceptability of the standardized OMT procedure for CM, and gather preliminary data on its potential efficacy when implemented in a primary care setting. The central hypothesis is that the standardized myofascial release OMT procedure will improve symptoms of CM as measured by improvement in HIT-6, Migraine Disability Assessment (MIDAS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), and self-reported and electronic health record (EHR) medication usage and healthcare utilization. This hypothesis is supported by the investigators' anecdotal clinical success using this approach. The specific aims of this study are:
Aim 1: Assess the feasibility of systematically identifying and treating patients with the standardized OMT procedure within the Penn State Health medical system. Feasibility will be measured by the investigators' ability to identify and enroll CM patients in this study. The investigators will enroll 20-40 adult patients with CM who do not have common confounders. This data will inform the recruitment strategy of a future randomized clinical trial (RCT).
Aim 2: Assess the acceptability of the standardized OMT procedure. Acceptability will be measured by patient-reported satisfaction and perceived benefit, completion rate and adverse events or side-effects. This data will inform the sample size calculation of a future RCT.
Aim 3: Assess the preliminary effectiveness of the standardized OMT procedure. Efficacy will be measured by improvement in HIT-6, MIDAS, and MSQ scores; patient-reported headache frequency, medication usage, and healthcare utilization surveys; and medication and healthcare utilization documented in the EHR. This data will provide estimates of effect size to better inform the sample size calculation of a future RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consenting chronic migraine patients will receive 3-5 standardized osteopathic manipulative treatments over the course of ten weeks, and will be assessed for acceptance and efficacy of the treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Osteopathic manipulative therapyParticipants will receive 5 standardized osteopathic manipulative treatments, two weeks apart. (To be considered a study completer, a participant must complete at least 3 of these treatments.) In addition to assessments at intake and during treatments, 1 and 3 months after their last treatment patients will be asked to provide follow-up data. Assessments include the HIT-6, MIDAS, and MSQ surveys, treatment satisfaction assessments, and a headache diary. Participants will also consent to an electronic medical record extraction of medication and healthcare services utilization. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- An adult ≥ 18 years of age and ≤ 60 years of age
- Enrolled for care at Penn State Hershey Family and Community Medicine as demonstrated by at least one primary care visit within the past 3 years
- Diagnosed with chronic migraine (as defined by the International Headache Society: "Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache"
- Legally and physically able to consent in English
- Willing and able to complete seven in-person visits, each approximately 30 minutes in length, over the course of 21 weeks.
Key exclusion criteria (15 listed)
- Are diagnosed with secondary headache
- Are pregnant (as reported at the time of enrollment; no pregnancy test is required; patients who become pregnant during the study will be withdrawn from the study. (However, they may continue to receive non-study related OMT treatments through their primary care provider as OMT has been shown to be safe in pregnancy.))
- Are less than 18 or more than 60 years of age
- Are diagnosed with fibromyalgia.
- Have current or prior migraine or other headache treatment with onabotulinumtoxinA (Botox®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulative therapyAlso: OMT, myofascial release1. Mandibular: the clinician applies gentle pressure bilaterally to the subject's mandible, in the direction of the patient's clavicles. 2. Frontal: the clinician applies gentle pressure bilaterally to the subject's forehead, in a direction halfway between the parietals and ears. 3. Temporal: the clinician applies gentle pressure bilaterally to the subject's temples, in the direction of the patient's occiput. 4. Parietal: the clinician applies gentle pressure bilaterally to the subject's parietal bones, in the direction of the patient's occipital atlanto joint. 5. Occipital: the clinician applies gentle pressure to the subject's occipital bone, in the direction of the patient's neck. | Procedure or surgery | Intervention |
Primary outcome
Recruitment metrics
Time frame: 6 months
Number of eligible patients identified through electronic medical record search, number of contacts needed to schedule an appointment, number of consent meetings to enroll a patient, number of patients who complete the study
Treatment satisfaction, first treatment
Time frame: 1st treatment, week 12
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment and likelihood of continuing treatments.
Treatment satisfaction, second treatment
Time frame: 2nd treatment, week 14
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Treatment satisfaction, second treatment
Time frame: 3rd treatment, week 16
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Treatment satisfaction, second treatment
Time frame: 4th treatment, week 18
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
Treatment satisfaction, second treatment
Time frame: 5th treatment, week 20
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine
16 secondary outcomes
Headache impact test (HIT-6)
Time frame: 1st treatment, week 12
Headache impact test (HIT-6)
Time frame: 1 month post-intervention, week 24
Headache impact test (HIT-6)
Time frame: 3 months post-intervention, week 36
MIDAS (Migraine Disability Assessment Test)
Time frame: 1st treatment, week 12
MIDAS (Migraine Disability Assessment Test)
Time frame: 3 months post-intervention, week 36
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time frame: 1st treatment, week 12
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time frame: 1 month post-intervention, week 24
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time frame: 3 months post-intervention, week 36
Headache Diary
Time frame: 2nd treatment, week 14
Headache Diary
Time frame: 3rd treatment, week 16
Headache Diary
Time frame: 4th treatment, week 18
Headache Diary
Time frame: 5th treatment, week 20
Headache Diary
Time frame: 1 month post-intervention, week 24
Headache Diary
Time frame: 3 months post-intervention, week 36
Medication Use
Time frame: 3 months post-intervention from electronic health record, week 36
Healthcare Utilization
Time frame: 3 months post-intervention from electronic health record, week 36
Results and safety
The study was stopped early (reason given: Responsible Party left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 31563224Burch RC, Buse DC, Lipton RB. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019 Nov;37(4):631-649. doi: 10.1016/j.ncl.2019.06.001. Epub 2019 Aug 27.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 26833083Messali A, Sanderson JC, Blumenfeld AM, Goadsby PJ, Buse DC, Varon SF, Stokes M, Lipton RB. Direct and Indirect Costs of Chronic and Episodic Migraine in the United States: A Web-Based Survey. Headache. 2016 Feb;56(2):306-22. doi: 10.1111/head.12755. Epub 2016 Feb 1.
- Background: PubMed 29446063Bonafede M, Sapra S, Shah N, Tepper S, Cappell K, Desai P. Direct and Indirect Healthcare Resource Utilization and Costs Among Migraine Patients in the United States. Headache. 2018 May;58(5):700-714. doi: 10.1111/head.13275. Epub 2018 Feb 15.
- Background: PubMed 26407383Diener HC, Solbach K, Holle D, Gaul C. Integrated care for chronic migraine patients: epidemiology, burden, diagnosis and treatment options. Clin Med (Lond). 2015 Aug;15(4):344-50. doi: 10.7861/clinmedicine.15-4-344.
- Background: PubMed 27902848Silberstein SD. Topiramate in Migraine Prevention: A 2016 Perspective. Headache. 2017 Jan;57(1):165-178. doi: 10.1111/head.12997. Epub 2016 Nov 30.
- Background: PubMed 29204191Chiang CC, Starling AJ. OnabotulinumtoxinA in the treatment of patients with chronic migraine: clinical evidence and experience. Ther Adv Neurol Disord. 2017 Dec;10(12):397-406. doi: 10.1177/1756285617731521. Epub 2017 Sep 20.
- Background: PubMed 25847552Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.
- Background: PubMed 30763049Smith MS, Olivas J, Smith K. Manipulative Therapies: What Works. Am Fam Physician. 2019 Feb 15;99(4):248-252.
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- Background: PubMed 27696633Chaibi A, Benth JS, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):143-153. doi: 10.1111/ene.13166. Epub 2016 Oct 2.
- Background: PubMed 21385086Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Lennon, MD principal investigator
Penn State Health Milton S Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative therapy in people with Chronic Migraine, Headache, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Responsible Party left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment metrics (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04520425, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.