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Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

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ClinicalTrials.gov Identifier: NCT01851148
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Other: osteopathic manipulative treatment Other: sham treatment Drug: triptans Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT
Study Start Date : March 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Sumatriptan

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 Name: sham

Drug: triptans
administration of triptans drug treatment according to international guidelines

usual care
triptans treatment only
Drug: triptans
administration of triptans drug treatment according to international guidelines

Experimental: OMT
8 sessions of osteopathic manipulative treatment
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 Name: OMT

Drug: triptans
administration of triptans drug treatment according to international guidelines




Primary Outcome Measures :
  1. difference in HIT-6 score [ Time Frame: at entry and after 26 weeks ]

Secondary Outcome Measures :
  1. number of migraine attacks [ Time Frame: 26 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged between 18 and 60 years old
  • chronic migraine

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851148


Locations
Italy
Ancona's Hospital, division of neurology
Ancona, Italy, 60020
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Investigators
Study Chair: Francesco Cerritelli, MS, DO European Institute for Evidence Based Osteopathic Medicine

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Cerritelli, MS, DO, European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01851148     History of Changes
Other Study ID Numbers: MIOST-1
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

Keywords provided by Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine:
osteopathic manipulative treatment
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs