Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 8, 2013
First Posted Date  ICMJE May 10, 2013
Last Update Posted Date September 4, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
difference in HIT-6 score [ Time Frame: at entry and after 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
number of migraine attacks [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine
Official Title  ICMJE Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Sham Comparator: sham therapy
    subtracting serial sevel (McPartland 2003)
    Interventions:
    • Other: sham treatment
    • Drug: triptans
  • usual care
    triptans treatment only
    Intervention: Drug: triptans
  • Experimental: OMT
    8 sessions of osteopathic manipulative treatment
    Interventions:
    • Other: osteopathic manipulative treatment
    • Drug: triptans
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2013)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged between 18 and 60 years old
  • chronic migraine

Exclusion Criteria:

  • secondary forms of headache,
  • chronic illness,
  • psychiatric illness,
  • post-menopausal women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01851148
Other Study ID Numbers  ICMJE MIOST-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine
Study Sponsor  ICMJE European Institute for Evidence Based Osteopathic Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Francesco Cerritelli, MS, DO European Institute for Evidence Based Osteopathic Medicine
PRS Account European Institute for Evidence Based Osteopathic Medicine
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP