Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

NCT ID: NCT01851148

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Keywords

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osteopathic manipulative treatment migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sham therapy

subtracting serial sevel (McPartland 2003)

Group Type SHAM_COMPARATOR

sham treatment

Intervention Type OTHER

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

triptans

Intervention Type DRUG

administration of triptans drug treatment according to international guidelines

usual care

triptans treatment only

Group Type OTHER

triptans

Intervention Type DRUG

administration of triptans drug treatment according to international guidelines

OMT

8 sessions of osteopathic manipulative treatment

Group Type EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type OTHER

It consists of 8 sessions in 6 months. Each osteopathic session is based on a structural evaluation and an indirect technique treatment.

triptans

Intervention Type DRUG

administration of triptans drug treatment according to international guidelines

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

triptans

administration of triptans drug treatment according to international guidelines

Intervention Type DRUG

Other Intervention Names

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OMT sham

Eligibility Criteria

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Inclusion Criteria

* aged between 18 and 60 years old
* chronic migraine

Exclusion Criteria

* secondary forms of headache,
* chronic illness,
* psychiatric illness,
* post-menopausal women
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute for Evidence Based Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Francesco Cerritelli

MS, DO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Cerritelli, MS, DO

Role: STUDY_CHAIR

European Institute for Evidence Based Osteopathic Medicine

Locations

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Ancona's Hospital, division of neurology

Ancona, , Italy

Site Status

Countries

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Italy

References

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Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.

Reference Type RESULT
PMID: 21385086 (View on PubMed)

Schabert E, Crow WT. Impact of osteopathic manipulative treatment on cost of care for patients with migraine headache: a retrospective review of patient records. J Am Osteopath Assoc. 2009 Aug;109(8):403-7.

Reference Type RESULT
PMID: 19706829 (View on PubMed)

Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.

Reference Type DERIVED
PMID: 25847552 (View on PubMed)

Other Identifiers

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MIOST-1

Identifier Type: -

Identifier Source: org_study_id