title: Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache.
abstract: BACKGROUND
  Osteopathic 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.
  
  
  OBJECTIVE
  To explore the efficacy of OMTh for pain management in frequent episodic tension-type headache (TTH).
  
  
  METHODS
  Single-blind randomized placebo-controlled pilot study.
  
  
  METHODS
  Patients were recruited from 5 primary care settings.
  
  
  METHODS
  Forty-four patients who were affected by frequent episodic TTH and not taking any drugs for prophylactic management of episodic TTH were recruited.
  
  
  METHODS
  Patients 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Forty 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).
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: 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.
authors.forename: Guido
authors.initials: G
authors.lastname: Rolle
authors.affiliation: 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.
authors.forename: Lucio
authors.initials: L
authors.lastname: Tremolizzo
authors.affiliation: 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.
authors.forename: Francesco
authors.initials: F
authors.lastname: Somalvico
authors.affiliation: 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.
authors.forename: Carlo
authors.initials: C
authors.lastname: Ferrarese
authors.affiliation: 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.
authors.forename: Livio C
authors.initials: LC
authors.lastname: Bressan
mesh_terms: D000328:Adult; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D026301:Manipulation, Osteopathic; D010147:Pain Measurement; D010865:Pilot Projects; D016037:Single-Blind Method; D018781:Tension-Type Headache / Q000628:therapy*