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Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH)

NCT02592850 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-06-04

No results posted yet for this study

Summary

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects.

In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.

Conditions

  • Tension-Type Headache

Interventions

OTHER

osteopathic manipulative treatment

This intervention will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of temporo-mandibular joint disorders and cervical dysfunctions (semi-structured treatment). Specifically, OMT will focus on correcting those osteopathic dysfunctions found during the initial evaluation; both structural (including myofascial release and HVLA), visceral and craniosacral techniques will be administered as appropriate. Duration: 45 minutes. Administered once a week for four weeks.

OTHER

sham

In this intervention, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI), temporo-mandibular joint disorders and cervical dysfunctions, spending a similar amount of time to that being spent on OMT-treated patients. Any found osteopathic dysfunction will not be corrected. Duration: 45 minutes. Administered once a week for four weeks.

Sponsors & Collaborators

  • Italian School of Osteopathy and Manual Therapies

    collaborator OTHER

  • Alpha Search Milano

    collaborator UNKNOWN

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Lucio Tremolizzo, MD, PhD · University of Milano-Bicocca, Italy

  • Guido Rolle, DO, MD · Italian School of Osteopathy and Manual Therapies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592850 on ClinicalTrials.gov