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

Not Applicable

• Conditions: Primary Headache Disorder; Headache Disorders

• 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.

Study Timeline

• Study Start: 2018-06-18
• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-16
• Primary Completion: 2020-06-18
• Study Completion: 2020-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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