Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Headache Disorders
- Sponsor
- Antonio Francesco Urbino
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Number of days with headache
- Last Updated
- 6 years ago
Overview
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.
Investigators
Antonio Francesco Urbino
Director Pediatric Department
A.O.U. Città della Salute e della Scienza
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of days with headache
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- Adverse event(From first treatment (1 week post-baseline) up to end of treatment course (3 months).)