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

NCT04080258 | Unknown DMC

• 1 other identifier: 0063257
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Headache Disorders; Primary Headache

Outcome Measures

Primary Outcomes (1)

• Number of days with headache

  Difference in number of days per month with headache

  At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline.

Secondary Outcomes (4)

• Reduction of analgesic use

  At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline

• Reduction of functional disability (school and leisure activity)

  At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline

• Reduction of headache intensity

  At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline

• Adverse event

  From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Study Arms (2)

Osteopathic Manipulative Therapy

EXPERIMENTAL

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.

Other: Osteopathic manipulative therapy (OMTh)

Light Touch Therapy

SHAM COMPARATOR

Participants to the LTT group will receive the protocol at the same date of the OMTh group.

Other: Light Touch Therapy (LTT)

Interventions

Osteopathic manipulative therapy (OMTh) OTHER

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.

Osteopathic Manipulative Therapy

Light Touch Therapy (LTT) OTHER

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.

Light Touch Therapy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of primary high-frequency headache attacks.
• No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.

You may not qualify if:

• Secondary headache.

Sponsors & Collaborators

• Antonio Francesco Urbino: lead
• Scuola Superiore di Osteopatia Italiana: collaborator

Study Sites (1)

Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.

Torino, 10126, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 27102894 BACKGROUND

• 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.

  PMID: 26750538 BACKGROUND

• 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.

  PMID: 30444269 BACKGROUND

• 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.

  PMID: 23776117 BACKGROUND

• 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: 25847552 BACKGROUND

MeSH Terms

Conditions

Headache Disorders; Headache Disorders, Primary

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Antonio F Urbino, Medical

  A.O.U. Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donatella F Bagagiolo, Osteopath

CONTACT

0039 3405587818; donatella.bagagiolo@gmail.com

Antonia Versace, Medical

CONTACT

00390113131735; aversace@cittadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects will be randomly assigned to two groups, OMTh and LTT, and will be randomized from a computer-generated list prepared in advance by an external statistician. Allocation will be concealed with opaque sealed envelopes which will be opened after enrolment. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Pediatric Department

Model Details: A two arms randomized controlled trial. The experimental group will receive Osteopathic Manipulative Therapy and the Active Comparator will receive Light Touch Therapy.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: June 18, 2018
• Primary Completion: June 18, 2020
• Study Completion: December 18, 2020
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

IT (1)