NCT01851148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
Last Updated

September 4, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

May 8, 2013

Last Update Submit

August 31, 2013

Conditions

Migraine

Keywords

osteopathic manipulative treatmentmigraine

Outcome Measures

Primary Outcomes (1)

  • difference in HIT-6 score

    at entry and after 26 weeks

Secondary Outcomes (1)

  • number of migraine attacks

    26 weeks

Study Arms (3)

sham therapy

SHAM COMPARATOR

subtracting serial sevel (McPartland 2003)

Other: sham treatmentDrug: triptans

usual care

OTHER

triptans treatment only

Drug: triptans

OMT

EXPERIMENTAL

8 sessions of osteopathic manipulative treatment

Other: osteopathic manipulative treatmentDrug: triptans

Interventions

osteopathic manipulative treatmentOTHER

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

Also known as: OMT
OMT
sham treatmentOTHER

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

Also known as: sham
sham therapy
triptansDRUG

administration of triptans drug treatment according to international guidelines

OMTsham therapyusual care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 18 and 60 years old
  • chronic migraine

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ancona's Hospital, division of neurology

Ancona, 60020, Italy

Location

Related Publications (3)

  • 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.

    PMID: 21385086RESULT

  • 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.

    PMID: 19706829RESULT

  • 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.

    PMID: 25847552DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Manipulation, Osteopathicsalicylhydroxamic acidTryptamines

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Francesco Cerritelli, MS, DO

    European Institute for Evidence Based Osteopathic Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, DO

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 10, 2013

Study Start

March 1, 2010

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

September 4, 2013

Record last verified: 2013-08

Locations

IT(1)