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Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
sham treatment
triptans
Sponsored by
European Institute for Evidence Based Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring osteopathic manipulative treatment, migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged between 18 and 60 years old
  • chronic migraine

Exclusion Criteria:

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

Sites / Locations

  • Ancona's Hospital, division of neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Other

Experimental

Arm Label

sham therapy

usual care

OMT

Arm Description

subtracting serial sevel (McPartland 2003)

triptans treatment only

8 sessions of osteopathic manipulative treatment

Outcomes

Primary Outcome Measures

difference in HIT-6 score

Secondary Outcome Measures

number of migraine attacks

Full Information

First Posted
May 8, 2013
Last Updated
August 31, 2013
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01851148
Brief Title
Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine
Official Title
Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
osteopathic manipulative treatment, migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham therapy
Arm Type
Sham Comparator
Arm Description
subtracting serial sevel (McPartland 2003)
Arm Title
usual care
Arm Type
Other
Arm Description
triptans treatment only
Arm Title
OMT
Arm Type
Experimental
Arm Description
8 sessions of osteopathic manipulative treatment
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Other Intervention Name(s)
OMT
Intervention Description
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
Intervention Name(s)
sham treatment
Other Intervention Name(s)
sham
Intervention Description
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
Drug
Intervention Name(s)
triptans
Intervention Description
administration of triptans drug treatment according to international guidelines
Primary Outcome Measure Information:
Title
difference in HIT-6 score
Time Frame
at entry and after 26 weeks
Secondary Outcome Measure Information:
Title
number of migraine attacks
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, MS, DO
Organizational Affiliation
European Institute for Evidence Based Osteopathic Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ancona's Hospital, division of neurology
City
Ancona
ZIP/Postal Code
60020
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21385086
Citation
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.
Results Reference
result
PubMed Identifier
19706829
Citation
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.
Results Reference
result
PubMed Identifier
25847552
Citation
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.
Results Reference
derived

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Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

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