Clinical trial NCT04080258: Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
Official title: Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache Disorders
Primary Headache Disorder
Keywords: Headache Disorders
Primary Headache
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: Scuola Superiore di Osteopatia Italiana
First posted: 2019-09-06
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two arms randomized controlled trial. The experimental group will receive Osteopathic Manipulative Therapy and the Active Comparator will receive Light Touch Therapy.
Primary purpose: TREATMENT

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.

Detailed description: Headache is one of the most common medical complaints in childhood, with migraine and tension-type headaches (TTHs) being the most frequent diseases. The prevalence of tension-type headache (TTH) varies from 10% to 25% in school children and adolescents. Therefore a range varying from 0,1% to 5,9% of this population presents chronic tension-type headache, occuring at least 15 days on a monthly basis.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Secondary headache.

Primary outcomes:
measure: Number of days with headache
timeFrame: At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline.
Secondary outcomes:
measure: Reduction of analgesic use
timeFrame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
measure: Reduction of functional disability (school and leisure activity)
timeFrame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
measure: Reduction of headache intensity
timeFrame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
measure: Adverse event
timeFrame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Antonio F Urbino, Medical
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.