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| Name | Class |
|---|---|
| Scuola Superiore di Osteopatia Italiana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Light Touch Therapy | Sham Comparator | Participants to the LTT group will receive the protocol at the same date of the OMTh group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reduction of functional disability (school and leisure activity) |
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Inclusion Criteria:
Exclusion Criteria:
Secondary headache.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donatella F Bagagiolo, Osteopath | Contact | 0039 3405587818 | donatella.bagagiolo@gmail.com | |
| Antonia Versace, Medical | Contact | 00390113131735 | aversace@cittadellasalute.to.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio F Urbino, Medical | A.O.U. Città della Salute e della Scienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza. | Recruiting | Torino | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27102894 | Background | 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. | |
| 26750538 | 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. |
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D051270 | Headache Disorders, Primary |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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A two arms randomized controlled trial. The experimental group will receive Osteopathic Manipulative Therapy and the Active Comparator will receive Light Touch Therapy.
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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.
|
| 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. |
|
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 |
| 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 |
| 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). |
| 30444269 | 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. |
| 23776117 | 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. |
| 25847552 | 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. |
| D012046 | Rehabilitation |