Study Summary
This study is evaluating whether Osteopathic Manipulative Therapy (OMT) can reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents.
Eligible Conditions
- Migraine
- Headache Disorders
- Chronic Migraine
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: 12 weeks
12 weeks
Headache Days
Pain scale
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Interventional Group receiving Osteopathic Manipulative Therapy (OMT)
1 of 1
Experimental Treatment
140 Total Participants · 1 Treatment Group
Primary Treatment: Osteopathic Manipulative Therapy (OMT) · No Placebo Group · N/A
Interventional Group receiving Osteopathic Manipulative Therapy (OMT)
Procedure
Experimental Group · 1 Intervention: Osteopathic Manipulative Therapy (OMT) · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Who is running the clinical trial?
St. Luke's Hospital, PennsylvaniaLead Sponsor
17 Previous Clinical Trials
2,986 Total Patients Enrolled
Abby Rhoads, DOPrincipal InvestigatorSt. Luke's Hospital and Health Network, Pennsylvania
Eligibility Criteria
Age 18 - 50 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:ICD 10 code for migraine with or without aura is G43.0, G43.1, G43.70, G43.71.
There was no change in prophylactic medication for both the control and intervention group.
There was no physical therapy for headaches, neck pain, or trapezius muscle during 12 weeks for both the control and intervention groups.
There are two genders, male and female.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| St. Luke's University Health Network | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22. Review.
- Cerritelli F, Lacorte E, Ruffini N, Vanacore N. Osteopathy for primary headache patients: a systematic review. J Pain Res. 2017 Mar 14;10:601-611. doi: 10.2147/JPR.S130501. eCollection 2017. Review.
- Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018 Apr;58(4):496-505. doi: 10.1111/head.13281. Epub 2018 Mar 12.
- McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic manipulative treatment in the management of acute neck pain in the emergency department: a randomized clinical trial. J Am Osteopath Assoc. 2005 Feb;105(2):57-68.
- Voigt, Karen, Jan Liebnitzky, Ute Burmeister, Henna Sihvonen-Riemenschneider, Matthias Beck, Roger Voigt, and Antje Bergmann. 2011. “Efficacy of Osteopathic Manipulative Treatment of Female Patients with Migraine: Results of a Randomized Controlled Trial”. The Journal of Alternative and Complementary Medicine. Mary Ann Liebert Inc. doi:10.1089/acm.2009.0673.
- Zein-Hammoud M, Standley PR. Modeled Osteopathic Manipulative Treatments: A Review of Their in Vitro Effects on Fibroblast Tissue Preparations. J Am Osteopath Assoc. 2015 Aug;115(8):490-502. doi: 10.7556/jaoa.2015.103. Review.
- Francesco Cerritelli, et al. Is osteopathic manipulative treatment effective in migraine?. International Journal of Osteopathic Medicine. March 2013Volume 16, Issue 1, Pages e1-e2.
- Cerritelli F, Lacorte E, Ruffini N, Vanacore N. Osteopathy for primary headache patients: a systematic review. J Pain Res. 2017 Mar 14;10:601-611. doi: 10.2147/JPR.S130501. eCollection 2017.
- Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22.
- Zein-Hammoud M, Standley PR. Modeled Osteopathic Manipulative Treatments: A Review of Their in Vitro Effects on Fibroblast Tissue Preparations. J Am Osteopath Assoc. 2015 Aug;115(8):490-502. doi: 10.7556/jaoa.2015.103.
- 2018. "Osteopathic Manipulative Treatment and Migraine Headaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976985.