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Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.

NCT04080258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-09-16

No results posted yet for this study

Summary

The aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.

Conditions

  • Headache Disorders
  • Primary Headache Disorder

Interventions

OTHER

Osteopathic manipulative therapy (OMTh)

The Osteopathic Manipulative Therapy includes both evaluation and treatment. The evaluation is semi-structured, two osteopaths will assess the presence of somatic dysfunctions which have to include the hyoid-pharyngeal, laryngeal, temporo-mandibular and lingual areas. The therapy is based on the treatment of somatic dysfunctions with different approaches that include: the balanced ligamentous tension technique, the myofascial release, the visceral manipulation, and the balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 of evaluation and 30 of treatment.

OTHER

Light Touch Therapy (LTT)

The Light Touch Therapy is a sham treatment consistent with the OMTh one during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body by moving the hands every few seconds and by flattening and softening the surface of the hands in order to minimize focal areas of force.

Sponsors & Collaborators

  • Scuola Superiore di Osteopatia Italiana

    collaborator OTHER

  • Antonio Francesco Urbino

    lead OTHER

Principal Investigators

  • Antonio F Urbino, Medical · A.O.U. Città della Salute e della Scienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2020-06-18
Completion
2020-12-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080258 on ClinicalTrials.gov