An interventional study of Osteopathic manipulative therapy (OMTh) and Light Touch Therapy (LTT) in Headache Disorders and Primary Headache Disorder, sponsored by Antonio Francesco Urbino. Status unknown at 1 site in Italy. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Antonio Francesco Urbino · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Secondary headache.
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.
Other: Osteopathic manipulative therapy (OMTh)
Participants to the LTT group will receive the protocol at the same date of the OMTh group.
Other: Light Touch Therapy (LTT)
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.
Number of days with headache
Difference in number of days per month 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.
Reduction of analgesic use
Difference in reduction of analgesic use per month
Time frame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Reduction of functional disability (school and leisure activity)
Days per month with functional disability.
Time frame: 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
Difference in intensity of pain: mild, moderate and severe
Time frame: At baseline (T0), after 1 month (T1), at 3 months form baseline (T2) and follow-up at 6 months from baseline
Adverse event
Symptoms such as increased of pain that could occur after the Osteopathic Manipulative Therapy or Light Touch Therapy
Time frame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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