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

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

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

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.

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

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.

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.

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.

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.

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

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

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

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

Symptoms such as increased of pain that could occur after the Osteopathic Manipulative Therapy or Light Touch Therapy

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.

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