Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

August 31, 2013 updated by: Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine

Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT

The aim of the present study is to determine the extend to which OMT is effective on a sample of subjects affected by migraine evaluated using the headache impact test (HIT-6) questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60020
        • Ancona's Hospital, division of neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 18 and 60 years old
  • chronic migraine

Exclusion Criteria:

  • secondary forms of headache,
  • chronic illness,
  • psychiatric illness,
  • post-menopausal women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: sham therapy
subtracting serial sevel (McPartland 2003)
Other: sham treatment
Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. The practitioner's attention was distracted by subtracting serial seven calculation in silence
Other Names:
  • sham
Drug: triptans
administration of triptans drug treatment according to international guidelines
OTHER: usual care
triptans treatment only
Drug: triptans
administration of triptans drug treatment according to international guidelines
EXPERIMENTAL: OMT
8 sessions of osteopathic manipulative treatment
Drug: triptans
administration of triptans drug treatment according to international guidelines
Other: osteopathic manipulative treatment
It consists of 8 sessions in 6 months. Each osteopathic session is based on a structural evaluation and an indirect technique treatment.
Other Names:
  • OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in HIT-6 score
Time Frame: at entry and after 26 weeks
at entry and after 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
number of migraine attacks
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Investigators

  • Study Chair: Francesco Cerritelli, MS, DO, European Institute for Evidence Based Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2013

Last Update Submitted That Met QC Criteria

August 31, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIOST-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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