Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
NCT ID: NCT04080258
Last Updated: 2019-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2018-06-18
2020-12-18
Brief Summary
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Detailed Description
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The tension-type headache is most likely multifactorial. In children, a connection seems possible between tension-type headache and psychosocial stress, psychiatric disorders, muscular stress, or oromandibular dysfunction.
The treatment of tension-type headache covers a systemic approach that includes both pharmacologic and nonpharmacologic therapies, such as biobehavioural management, and patient and family education regarding lifestyle modifications to develop and/or maintain healthy habits. Efficacy of these therapies is still unclear. Complementary therapies could be a good support to pharmacologic treatment. Osteopathic treatment results effective in some paediatric conditions, but in primary headache the possible efficacy is still unknown.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The paediatrician in charge of the outcome assessor will be blinded to allocation concealment. The nurse staff, and the osteopath in charge of collecting the data will be blinded to group assignment.
The two osteopaths in charge of Osteopathic Manipulative Therapy and Light Touch Therapy will be unblinded to group assignment.
Data export will be performed by the external statistician. The blind-to-treatment allocation was tested using a post-treatment single question survey conducted by the pediatrician.
Study Groups
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Osteopathic Manipulative Therapy
Osteopathic Manipulative Therapy (OMTh). Patients in the OMTh group will receive 5 Osteopathic manipulative therapies: the first at baseline, the second after 1 week, the third after 3 weeks, and then 2 more treatments on a monthly basis. The protocol will last for three months.
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.
Light Touch Therapy
Participants to the LTT group will receive the protocol at the same date of the OMTh group.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.
Exclusion Criteria
8 Years
18 Years
ALL
No
Sponsors
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Scuola Superiore di Osteopatia Italiana
OTHER
Antonio Francesco Urbino
OTHER
Responsible Party
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Antonio Francesco Urbino
Director Pediatric Department
Principal Investigators
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Antonio F Urbino, Medical
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Città della Salute e della Scienza
Locations
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Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Antonio F Urbino, Medical
Role: primary
References
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Huguet A, Tougas ME, Hayden J, McGrath PJ, Chambers CT, Stinson JN, Wozney L. Systematic Review of Childhood and Adolescent Risk and Prognostic Factors for Recurrent Headaches. J Pain. 2016 Aug;17(8):855-873.e8. doi: 10.1016/j.jpain.2016.03.010. Epub 2016 Apr 19.
Gofshteyn JS, Stephenson DJ. Diagnosis and Management of Childhood Headache. Curr Probl Pediatr Adolesc Health Care. 2016 Feb;46(2):36-51. doi: 10.1016/j.cppeds.2015.11.003. Epub 2015 Dec 29.
Kroon Van Diest AM, Powers SW. Cognitive Behavioral Therapy for Pediatric Headache and Migraine: Why to Prescribe and What New Research Is Critical for Advancing Integrated Biobehavioral Care. Headache. 2019 Feb;59(2):289-297. doi: 10.1111/head.13438. Epub 2018 Nov 16.
Posadzki P, Lee MS, Ernst E. Osteopathic manipulative treatment for pediatric conditions: a systematic review. Pediatrics. 2013 Jul;132(1):140-52. doi: 10.1542/peds.2012-3959. Epub 2013 Jun 17.
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.
Other Identifiers
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0063257
Identifier Type: -
Identifier Source: org_study_id
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