Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of days with headache
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The subjects will be randomly assigned to two groups, OMTh and LTT, and will be randomized from a computer-generated list prepared in advance by an external statistician. Allocation will be concealed with opaque sealed envelopes which will be opened after enrolment.
The paediatrician in charge of the outcome assessor will be blinded to allocation concealment. The nurse staff, and the osteopath in charge of collecting the data will be blinded to group assignment.
The two osteopaths in charge of Osteopathic Manipulative Therapy and Light Touch Therapy will be unblinded to group assignment.
Data export will be performed by the external statistician. The blind-to-treatment allocation was tested using a post-treatment single question survey conducted by the pediatrician.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary high-frequency headache attacks.
- •No reduction or inconsistent reduction of attacks after two months of prophylactic treatment.
排除标准
- •Secondary headache.
研究组 & 干预措施
Osteopathic Manipulative Therapy
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.
干预措施: Osteopathic manipulative therapy (OMTh) (Other)
Light Touch Therapy
Participants to the LTT group will receive the protocol at the same date of the OMTh group.
干预措施: Light Touch Therapy (LTT) (Other)
结局指标
主要结局
Number of days with headache
时间窗: 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
次要结局
- 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).)
研究者
Antonio Francesco Urbino
Director Pediatric Department
A.O.U. Città della Salute e della Scienza