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Completed

NCT Number: NCT01851148

Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ancona's Hospital, division of neurology

Ancona, 60020, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 60 years old
  • chronic migraine

Exclusion criteria

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

Treatment and study plan

Osteopathic manipulative treatment

Other

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

Sham Treatment

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

Other names: sham

Triptans

Drug

administration of triptans drug treatment according to international guidelines

Primary outcomes

  1. difference in HIT-6 score

    Time frame: at entry and after 26 weeks

Secondary outcomes

  1. number of migraine attacks

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

European Institute for Evidence Based Osteopathic Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 10, 2013
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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