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

Antonio Francesco Urbino

Status: Unknown

Conditions: Headache Disorders; Primary Headache Disorder

Treatments: Other: Light Touch Therapy (LTT); Other: Osteopathic manipulative therapy (OMTh)

Study type: Interventional

Funder types: Other

Identifiers

NCT04080258

0063257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Osteopathic Manipulative Therapy

Experimental group

Description:

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.

Treatment:

Other: Osteopathic manipulative therapy (OMTh)

Light Touch Therapy

Sham Comparator group

Description:

Participants to the LTT group will receive the protocol at the same date of the OMTh group.

Treatment:

Other: Light Touch Therapy (LTT)