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J Am Osteopath Assoc · Sep 2014
Randomized Controlled TrialPilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache.
- Guido Rolle, Lucio Tremolizzo, Francesco Somalvico, Carlo Ferrarese, and Livio C Bressan.
- From the Italian School of Osteopathy and Manual Therapies (SIOTEMA) in Sartirana (Dr Rolle); the Neurology Unit at the University of Milano-Bicocca in Monza (Drs Tremolizzo and Ferrarese); Alpha Search in Milan (Mr Somalvico); and Istituti Clinici di Perfezionamento in Milan (Dr Bressan), Italy guidorolle@libero.it.
- J Am Osteopath Assoc. 2014 Sep 1; 114 (9): 678-85.
ContextOsteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) may be used for managing headache pain and related disability, but there is a need for high-quality randomized controlled trials to assess the effectiveness of this intervention.ObjectiveTo explore the efficacy of OMTh for pain management in frequent episodic tension-type headache (TTH).DesignSingle-blind randomized placebo-controlled pilot study.SettingPatients were recruited from 5 primary care settings.PatientsForty-four patients who were affected by frequent episodic TTH and not taking any drugs for prophylactic management of episodic TTH were recruited.InterventionsPatients were randomly allocated to an experimental or control group. The experimental group received corrective OMTh techniques, tailored for each patient; the control group received assessment of the cranial rhythmic impulse (sham therapy). The study included a 1-month baseline period, a 1-month treatment period, and a 3-month follow-up period.Main Outcome MeasuresThe primary outcome was the change in patient-reported headache frequency, and secondary outcomes included changes in headache pain intensity (discrete score, 1 [lowest perceived pain] to 5 [worst perceived pain]), over-the-counter medication use, and Headache Disability Inventory score.ResultsForty patients completed the study (OMTh, n=21; control, n=19). The OMTh group had a significant reduction in headache frequency over time that persisted 1 month (approximate reduction, 40%; P<.001) and 3 months (approximate reduction, 50%; P<.001) after the end of treatment. Moreover, there was an absolute difference between the 2 treatment groups at the end of the study, with a 33% lower frequency of headache in the OMTh group (P<.001).ConclusionThis feasibility study demonstrated the efficacy of OMTh in the management of frequent episodic TTH, compared with sham therapy in a control group. Osteopathic manipulative therapy may be preferred over other treatment modalities and may benefit patients who have adverse effects to medications or who have difficulty complying with pharmacologic regimens. This protocol may serve as a model for future studies.© 2014 The American Osteopathic Association.
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