Headache Disorders, Primary Headache Disorder
Conditions
Keywords
Headache Disorders, Primary Headache
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.
Interventions
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.
Sponsors
Scuola Superiore di Osteopatia Italiana
Antonio Francesco Urbino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with headache | At baseline (T0), after 1 month (T1), at 3 months from baseline (T2) and follow-up at 6 months from baseline. | Difference in number of days per month with headache |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of analgesic use | At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline | Difference in reduction of analgesic use per month |
| Reduction of functional disability (school and leisure activity) | At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline | Days per month with functional disability. |
| Reduction of headache intensity | At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline | Difference in intensity of pain: mild, moderate and severe |
| Adverse event | From first treatment (1 week post-baseline) up to end of treatment course (3 months). | Symptoms such as increased of pain that could occur after the Osteopathic Manipulative Therapy or Light Touch Therapy |
Countries
Italy
Contacts
Primary ContactDonatella F Bagagiolo, Osteopath
Backup ContactAntonia Versace, Medical
Outcome results
None listed