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The Efficacy of Osteopathic Manipulative Treatment on Decreasing the Severity of Migraine Headaches

Journal: Journal of Osteopathic Medicine Date: 2019/12, 119(12):Pages: e93-e95. doi: Subito , type of study: clinical trial

Full text    (https://www.degruyter.com/document/doi/10.7556/jaoa.2019.128/html)

Keywords:

clinical trial [612]
headache [127]
migraine [57]
OMT [2951]
osteopathic manipulative treatment [2973]

Abstract:

Statement of Significance: Historically, OMT was believed to worsen migraine headaches, this study is being conducted to learn about how Osteopathic Manipulative Treatment can help migraine patients. Participants receiving OMT could benefit from improved quality of life by decreasing participant's severity and frequency of their migraine headaches, which could improve their productivity to society and decrease the economic burden of migraine headaches. Headache accounts for the fourth or fifth most common reason for emergency department visits and the economic burden of migraine reaches $78 billion dollars per year. This could provide information to acknowledge OMT techniques evaluated by this study as a recognized treatment of migraine headaches. Research Methods: After IRB approval, participants were recruited at St. Luke's Family and Internal Medicine departments in Bethlehem, Pennsylvania. A total of 140 participants will participate ( n=70 intervention group, n=70 control group), and this is an interim analysis of the first ten patients enrolled. Participants 18-50 years old, male and female, with diagnosis of migraine with or without aura, any ethnicity or race who agree to OMT will be included. Exclusion criteria include: previous surgery to neck or cranium, history of previous stroke, more than 2 daily prophylactic pharmacologic agents, active cancer, receiving BOTOX for migraines within the last 4 months, contraindications for OMT such as clinical signs of fractures in cervical spine, unable to follow commands, seizure disorder or recent head trauma. The intervention group will receive OMT for 30 minutes at 0, 2, 6, 10 week time-points, participants take MIDAS and HIT-6 questionnaires at baseline prior to first treatment and then at completion of 12 weeks. The Manipulative Medicine Protocol includes the following treatments: OA release, muscle energy and soft tissue to mid trapezius muscle, muscle energy to cervical spine in all 3planes of flexion/extension, rotation and side bending, screening for tender points of C2-C6 at transverse and spinous processes followed by counterstain if a tender point is identified, soft tissue to cervical paraspinal muscles, myo-fascial release of frontal forehead, and CV4 cranial technique. Data Analysis: Using PASS software [Hintze, J. (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA], we calculated sample size for our primary outcome of MIDAS scores based on previous study by Voight et al (2011) comparing MIDAS scores before and after manipulation therapy. This study revealed a mean of 24.8 for the treatment group and 28.6 for the control group. In order to detect this difference, allowing for moderate sample variability, we require a minimum of 70 patients per group (N=140) for 80% power at alpha=.05. For analysis of the interim results of first ten patients enrolled, all statistical analyses were conducted in IBM SPSS for Windows Version 18. Wilcoxon signed rank test was used for the comparisons because the data was not normally distributed and there was high SD relative to the mean. P values <.05 are considered statistically significant. One of the ten patients were removed from the study due to loss of follow up with protocol treatment schedule. Each participant's severity of migraine is assessed by the level of disability determined by the MIDAS score. The MIDAS level of disability is calculated by the following scoring system: 0 to 5 - MIDAS Grade I, Little or no disability; 6 to 10 - MIDAS Grade II, Mild disability; 11 to 20 - MIDAS Grade III, Moderate disability; 21+ - MIDAS Grade IV, Severe disability. Participant demographics included 9 female and 1 male, mean age 36 +/- 7, with 4participants age 18-30 and 6 participants age 31-50. Results: Results of 9 participants were included for the interim analysis of this pilot study after 1 participant was withdrawn due to loss of follow up. Seven out of 9 participants had improvement in MIDAS disability grade level, which was the primary endpoint: 3 participants improved from grade IV to grade I, 2 participants from grade IV grade II, 1 participant from grade IV to grade III, and finally, 1 participant from grade II to grade I. Wilcoxon signed rank test showed OMT significantly reduced MIDAS score with a pre-treatment median score of 27.0 (severe disability, grade IV) and post-treatment median score of 5.0 (little to no disability, grade I) with a p value of 0.03. All 3 secondary endpoints were significantly reduced including HIT-6 score, pre-treatment median score of 67.00, post-treatment median 58.00 (P<.01); headache frequency over 3 month period, pre-treatment median number of days was 20.00, post-treatment median number of days was 4.00 (P<.01); and headache severity by pain score, pre-treatment median score was 8 and post-treatment median score was 6.0 (P=.04). Conclusion: In conclusion, we have seen statistically significant improvement in both primary and secondary endpoints for the first 9 patients to complete the treatment protocol in this pilot study. This further validates the effects of OMT on migraine headache in regard to decreased disability, severity, pain intensity and number of days with migraine and is in agreement with previous studies including Voight, et al (2011) and Cerritelli, et al (2013). At St. Luke's University Hospital, we plan to enroll 70 participants in both the intervention group and a control group not receiving OMT. We hypothesize to continue to reproduce these significant results demonstrating OMT techniques to improve the severity and disability associated with migraine headaches. Future studies with larger sample size compared with control participants not receiving OMT or sham OMT should produce similar results.


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