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

Headache Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04080258
• Other study ID #: 0063257
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: December 18, 2020

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Donatella F Bagagiolo, Osteopath
• Phone: 0039 3405587818
• Email: donatella.bagagiolo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Headache
• Headache Disorders
• Headache Disorders, Primary
• Primary Headache Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Antonio Francesco Urbino	Scuola Superiore di Osteopatia Italiana

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of analgesic use	Difference in reduction of analgesic use per month	At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Secondary	Reduction of functional disability (school and leisure activity)	Days per month with functional disability.	At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Secondary	Reduction of headache intensity	Difference in intensity of pain: mild, moderate and severe	At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Secondary	Adverse event	Symptoms such as increased of pain that could occur after the Osteopathic Manipulative Therapy or Light Touch Therapy	From first treatment (1 week post-baseline) up to end of treatment course (3 months).