Study Summary
This trial will test if a specific osteopathic manipulative therapy can help treat chronic migraines. It will also see if patients are willing to try this therapy and if it shows any effectiveness.
Eligible Conditions
- Chronic Migraine
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: 3 months post-intervention, week 36
1st treatment, week 12
Treatment satisfaction, first treatment
Month 3
Healthcare Utilization
Medication Use
Month 3
Headache Diary
Headache impact test (HIT-6)
MIDAS (Migraine Disability Assessment Test)
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
5th treatment, week 20
Treatment satisfaction, second treatment
6 months
Recruitment metrics
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Intervention
1 of 1
Experimental Treatment
11 Total Participants · 1 Treatment Group
Primary Treatment: Osteopathic manipulative therapy · No Placebo Group · N/A
Intervention
Procedure
Experimental Group · 1 Intervention: Osteopathic manipulative therapy · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post-intervention, week 36
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
466 Previous Clinical Trials
2,785,823 Total Patients Enrolled
Robert P Lennon, MDPrincipal InvestigatorPenn State Health Milton S. Hershey Medical Center
Eligibility Criteria
Age 18 - 60 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You experience headaches for more than half the days in a month, with symptoms similar to migraine headaches on at least 8 of those days.
References
- Chiang, Chia-Chun, and Amaal J. Starling. 2017. “Onabotulinumtoxina in the Treatment of Patients with Chronic Migraine: Clinical Evidence and Experience”. Therapeutic Advances in Neurological Disorders. SAGE Publications. doi:10.1177/1756285617731521.
- Stevinson, Clare, and Edzard Ernst. 2002. “Risks Associated with Spinal Manipulation”. The American Journal of Medicine. Elsevier BV. doi:10.1016/s0002-9343(02)01068-9.
- Hammond, Nicole G., and Arne Stinchcombe. 2019. “Health Behaviors and Social Determinants of Migraine in a Canadian Population‐based Sample of Adults Aged 45‐85 Years: Findings from the CLSA”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.13610.
- Silberstein, Stephen D.. 2016. “Topiramate in Migraine Prevention: A 2016 Perspective”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12997.
- Bonafede, Machaon, Sandhya Sapra, Neel Shah, Stewart Tepper, Katherine Cappell, and Pooja Desai. 2018. “Direct and Indirect Healthcare Resource Utilization and Costs Among Migraine Patients in the United States”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.13275.
- Diener, Hans-Christoph, Kasja Solbach, Dagny Holle, and Charly Gaul. 2015. “Integrated Care for Chronic Migraine Patients: Epidemiology, Burden, Diagnosis and Treatment Options”. Clinical Medicine. Royal College of Physicians. doi:10.7861/clinmedicine.15-4-344.
- Coeytaux, Remy R., Jay S. Kaufman, Ryon Chao, J. Douglas Mann, and Robert F. DeVellis. 2006. “Four Methods of Estimating the Minimal Important Difference Score Were Compared to Establish a Clinically Significant Change in Headache Impact Test”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2005.05.010.
- “Headache Classification Committee of the International Headache Society (IHS) the International Classification of Headache Disorders, 3rd Edition”. 2018. “Headache Classification Committee of the International Headache Society (IHS) the International Classification of Headache Disorders, 3rd Edition”. Cephalalgia. SAGE Publications. doi:10.1177/0333102417738202.
- Messali, Andrew, Joanna C. Sanderson, Andrew M. Blumenfeld, Peter J. Goadsby, Dawn C. Buse, Sepideh F. Varon, Michael Stokes, and Richard B. Lipton. 2016. “Direct and Indirect Costs of Chronic and Episodic Migraine in the United States: A Web-based Survey”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12755.
- Smith MS, Olivas J, Smith K. Manipulative Therapies: What Works. Am Fam Physician. 2019 Feb 15;99(4):248-252. Review.
- Cole, JC, P Lin, and MFT Rupnow. 2009. “Minimal Important Differences in the Migraine-specific Quality of Life Questionnaire (MSQ) Version 2.1”. Cephalalgia. SAGE Publications. doi:10.1111/j.1468-2982.2009.01852.x.
- Jensen, R, C Tassorelli, P Rossi, M Allena, V Osipova, TJ Steiner, G Sandrini, et al.. 2011. “A Basic Diagnostic Headache Diary (BDHD) Is Well Accepted and Useful in the Diagnosis of Headache. A Multicentre European and Latin American Study”. Cephalalgia. SAGE Publications. doi:10.1177/0333102411424212.
- 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.
- Bigal, M. E., D. Serrano, M. Reed, and R. B. Lipton. 2008. “Chronic Migraine in the Population: Burden, Diagnosis, and Satisfaction with Treatment”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000323925.29520.e7.
- Burch, Rebecca C., Dawn C. Buse, and Richard B. Lipton. 2019. “Migraine”. Neurologic Clinics. Elsevier BV. doi:10.1016/j.ncl.2019.06.001.
- Stovner, Lars Jacob, Emma Nichols, Timothy J Steiner, Foad Abd-Allah, Ahmed Abdelalim, Rajaa M Al-Raddadi, Mustafa Geleto Ansha, et al.. 2018. “Global, Regional, and National Burden of Migraine and Tension-type Headache, 1990–2016: A Systematic Analysis for the Global Burden of Disease Study 2016”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(18)30322-3.
- Fraix, Marcel. 2010. “Osteopathic Manipulative Treatment and Vertigo: A Pilot Study”. Pm&r. Wiley. doi:10.1016/j.pmrj.2010.04.001.
- Hensel, Kendi L., Michael S. Carnes, and Scott T. Stoll. 2016. “Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol”. Journal of Osteopathic Medicine. Walter de Gruyter GmbH. doi:10.7556/jaoa.2016.142.
- Rendas-Baum, Regina, Min Yang, Sepideh F Varon, Lisa M Bloudek, Ronald E DeGryse, and Mark Kosinski. 2014. “Validation of the Headache Impact Test (HIT-6) in Patients with Chronic Migraine”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/s12955-014-0117-0.
- Stewart, W. F., R. B. Lipton, A. J. Dowson, and J. Sawyer. 2001. “Development and Testing of the Migraine Disability Assessment (MIDAS) Questionnaire to Assess Headache-related Disability”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.56.suppl_1.s20.
- Rendas-Baum, Regina, Lisa M. Bloudek, Gregory A. Maglinte, and Sepideh F. Varon. 2012. “The Psychometric Properties of the Migraine-specific Quality of Life Questionnaire Version 2.1 (MSQ) in Chronic Migraine Patients”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-012-0230-7.
- Cerritelli, Francesco, Liana Ginevri, Gabriella Messi, Emanuele Caprari, Marcello Di Vincenzo, Cinzia Renzetti, Vincenzo Cozzolino, Gina Barlafante, Nicoletta Foschi, and Leandro Provinciali. 2015. “Clinical Effectiveness of Osteopathic Treatment in Chronic Migraine: 3-armed Randomized Controlled Trial”. Complementary Therapies in Medicine. Elsevier BV. doi:10.1016/j.ctim.2015.01.011.
- Chaibi, Aleksander, Peter J. Tuchin, and Michael Bjørn Russell. 2011. “Manual Therapies for Migraine: A Systematic Review”. The Journal of Headache and Pain. Springer Science and Business Media LLC. doi:10.1007/s10194-011-0296-6.
- Park, Peter W., Richard D. Dryer, Rozelle Hegeman-Dingle, Jack Mardekian, Gergana Zlateva, Greg G. Wolff, and Lois E. Lamerato. 2015. “Cost Burden of Chronic Pain Patients in a Large Integrated Delivery System in the United States”. Pain Practice. Wiley. doi:10.1111/papr.12357.
- Odell, Jim, Carol Clark, Adrian Hunnisett, Osman Hassan Ahmed, and Jonathan Branney. 2019. “Manual Therapy for Chronic Migraine: A Pragmatic Randomised Controlled Trial Study Protocol”. Chiropractic & Manual Therapies. Springer Science and Business Media LLC. doi:10.1186/s12998-019-0232-4.
- Yang, Min, Regina Rendas-Baum, Sepideh F Varon, and Mark Kosinski. 2010. “Validation of the Headache Impact Test (HIT-6™) Across Episodic and Chronic Migraine”. Cephalalgia. SAGE Publications. doi:10.1177/0333102410379890.
- Chaibi, A., J. Š. Benth, P. J. Tuchin, and M. B. Russell. 2016. “Chiropractic Spinal Manipulative Therapy for Migraine: A Three-armed, Single-blinded, Placebo, Randomized Controlled Trial”. European Journal of Neurology. Wiley. doi:10.1111/ene.13166.
- Chaibi, A., J. Š. Benth, P. J. Tuchin, and M. B. Russell. 2016. “Chiropractic Spinal Manipulative Therapy for Migraine: A Three-armed, Single-blinded, Placebo, Randomized Controlled Trial”. European Journal of Neurology. Wiley. doi:10.1111/ene.13166.
- Stovner, Lars Jacob, Emma Nichols, Timothy J Steiner, Foad Abd-Allah, Ahmed Abdelalim, Rajaa M Al-Raddadi, Mustafa Geleto Ansha, et al.. 2018. “Global, Regional, and National Burden of Migraine and Tension-type Headache, 1990–2016: A Systematic Analysis for the Global Burden of Disease Study 2016”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(18)30322-3.
- Smith MS, Olivas J, Smith K. Manipulative Therapies: What Works. Am Fam Physician. 2019 Feb 15;99(4):248-252.
- GBD 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. Erratum In: Lancet Neurol. 2021 Dec;20(12):e7.
- Chiang 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.
- Headache 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.
- Coeytaux RR, Kaufman JS, Chao R, Mann JD, Devellis RF. Four methods of estimating the minimal important difference score were compared to establish a clinically significant change in Headache Impact Test. J Clin Epidemiol. 2006 Apr;59(4):374-80. doi: 10.1016/j.jclinepi.2005.05.010.
- Chaibi 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.
- Silberstein SD. Topiramate in Migraine Prevention: A 2016 Perspective. Headache. 2017 Jan;57(1):165-178. doi: 10.1111/head.12997. Epub 2016 Nov 30.
- Stevinson 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.
- Diener 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.
- Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011 Feb;31(3):357-67. doi: 10.1177/0333102410379890. Epub 2010 Sep 6.
- 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.
- Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
- Cole JC, Lin P, Rupnow MF. Minimal important differences in the Migraine-Specific Quality of Life Questionnaire (MSQ) version. Cephalalgia. 2009 Nov;29(11):1180-7. doi: 10.1111/j.1468-2982.2009.01852.x.
- Chaibi 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.
- Robert Lennon 2022. "Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520425.
Frequently Asked Questions
Does the eligibility criteria for this research encompass individuals younger than 60 years old?
"This trial is limited to those aged 18-60. For individuals younger than that, there are 43 trials available and for seniors, 178 studies can be accessed." - Anonymous Online Contributor
Unverified Answer
Is this research recruiting participants at the moment?
"According to clinicaltrials.gov, this medical study is not currently seeking patients after being posted on September 8th 2022 and last updated the same day. However, there are 262 other trials that are still actively searching for participants." - Anonymous Online Contributor
Unverified Answer
Am I eligible to partake in this medical trial?
"Qualifications to be admitted in this trial necessitate suffering from chronic migraine and being between the age of 18 and 60 years. A total of 40 patients will ultimately become partakers in this clinical study." - Anonymous Online Contributor
Unverified Answer
What is the ultimate objective of this experiment?
"The primary measurement of the trial's success will be recruitment metrics, to be assessed over a 5 week time span. Secondary endpoints include quantification of headache morbidity through Headache Impact Test-6 (HIT-6), Migraine Specific Quality Of Life Questionnaire Version 2.1 (MSQ) and patient self-assessment in the form of headaches diaries." - Anonymous Online Contributor
Unverified Answer