Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851148
• Other study ID #: MIOST-1
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: August 31, 2013
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• 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

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

Locations

Country	Name	City	State
Italy	Ancona's Hospital, division of neurology	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in HIT-6 score		at entry and after 26 weeks	No
Secondary	number of migraine attacks		26 weeks	No