Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
- Conditions
- Primary Headache DisorderHeadache Disorders
- Interventions
- Other: Osteopathic manipulative therapy (OMTh)Other: Light Touch Therapy (LTT)
- Registration Number
- NCT04080258
- Lead Sponsor
- Antonio Francesco Urbino
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Diagnosis of primary high-frequency headache attacks.
- No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.
Secondary headache.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Osteopathic Manipulative Therapy Osteopathic manipulative therapy (OMTh) 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 Light Touch Therapy (LTT) Participants to the LTT group will receive the protocol at the same date of the OMTh group.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Centro Cefalee dell'età evolutiva - Ospedale Infantile Regina Margherita S.C. Pediatria d'Urgenza.
🇮🇹Torino, Italy