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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Headache Disorders, Primary Headache Disorder

Intervention / Treatment
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* Other: Osteopathic manipulative therapy (OMTh)
* Other: Light Touch Therapy (LTT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic Manipulative Therapy<br>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)<br>* 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.<br>|
| Sham Comparator: Light Touch Therapy<br>Participants to the LTT group will receive the protocol at the same date of the OMTh group. | Other: Light Touch Therapy (LTT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache Disorders, Primary Headache