Abstract
Context:
In the US, 40 million people suffer from migraines; 8% have debilitating chronic migraines (CM). Standard care such as topiramate, onabotulinumtoxin A, and calcitonin gene-related peptide monoclonal antibodies are not universally effective and cause adverse effects (AE). Non-pharmacologic treatments such as osteopathic manipulative treatment (OMT) are reported effective and may minimize AEs but current studies are limited by non-uniformity of treatment protocols.
Objective:
To evaluate the feasibility of a standardized OMT procedure for CM and gather preliminary data on its effectiveness in a primary care setting.
Study Design & Analysis:
Prospective, single-arm feasibility study. Changes were evaluated using MANOVA to 95% confidence with f distribution for effect size.
Setting:
Outpatient clinical research center.
Population Studied:
Adults aged 18 to 60 seen within the last three years for chronic migraine (ICD 10 code G43.709) with no recent or ongoing treatment with topiramate or onabotulinumtoxin A.
Intervention/Instrument:
Participants received up to 5 biweekly treatments (minimum 3) of five 1-minute standardized myofascial release movements and completed 1- and 3-month post-treatment assessments.
Outcome Measures:
Primary: study completion rate and treatment satisfaction. Secondary: changes between baseline and 1-month, and baseline and 3-month scores on: Headache Impact Test (HIT-6) and the Migraine Specific Quality of Life Questionnaire (MSQ); changes between baseline and 3-month score on the Migraine Disability Assessment Test (MIDAS).
Results:
All 11 participants (mean age 47 years; 10 female, 1 male) completed the baseline, 1-, and 3-month assessments and ≥3 treatments. Treatment satisfaction was high (4.7/5). Improvements between baseline and 1-month were: HIT-6: 3.4->3.1 (p<.05, ηp2=0.16 (large effect)); MSQ: 2.9->2.2 (p=.087, ηp2=0.12 (medium effect)). Improvements between baseline and 3-month were: HIT-6: 3.4->2.9 (p=.074, ηp2=0.13 (medium effect)); MSQ: 2.9->2.0 (p=0.39, ηp2=0.09 (medium effect)); MIDAS: 9.1->5.6 (p<.05, ηp2=0.19 (large effect)).
Conclusions:
A standardized OMT protocol is feasible for chronic migraine treatment, with significant large effect size improvements on HIT-6 and MIDAS scores, and non-significant but medium effect size improvement on the MSQ. Improvements on the HIT-6 and MSQ wane over time. Further studies are warranted to confirm generalizability and characterize the extinction coefficient of efficacy.