Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- DOLOPLUS 2 score
研究概览
简要总结
This type of study can have an impact on public health policy and help improve the management of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological methods such as osteopathy; Help structuring the healthcare sector.
详细描述
- "Osteopathy" group: 3 osteopathy sessions of 45 min with one session every 3 weeks at S2, S5 and S8. Fascial osteopathic techniques performed will consist of gentle and non-impulsive manipulation
- "Simulated" group: 3 simulated osteopathy sessions lasting 45 minutes, one session every 3 weeks at S2, S5 and S8. The techniques performed will consist of an application of the hands to different anatomical regions than the group "osteopathy" without therapeutic intention, that is to say without tissue tensioning.
The pain will be assessed at inclusion (S0) and at the end of the procedure (S12) by the head physician, the coordinating physician or the psychomotor therapist, ignoring the assignment group of the subject and before each session. osteopathy (at S2, S5 and S8) by a nurse or psychomotor also ignoring the patient's assignment group.
Both groups will continue to benefit from their usual allopathic management and recommendations.
Patients will not be aware of the treatment received (osteopathy or simulated) and will be randomized by a computer server.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 75 years
- •Patients Residing in Accommodation Facilities for Dependent Old People
- •A score measured by the DOLOPLUS 2 Scale at least 7/30 at the start of the study
- •For patients in capacity and autonomous: Patients informed and having signed a free and informed consent.
- •For non-capable patients with a trusted person and / or guardian: Informed patients whose confidant or guardian has been informed and has signed free and informed consent.
- •Affiliated to a social security scheme (beneficiary or beneficiary)
排除标准
- •Absence of pain
- •Medical contraindication known to the practice of osteopathy with fascial aim (advanced degenerative bone disease, metastatic cancer)
- •Osteopathic treatment in the last six months
- •Patients under curators
研究组 & 干预措施
Sham osteopathy
干预措施: osteopathy (Other)
Real osteopathy
干预措施: osteopathy (Other)
结局指标
主要结局
DOLOPLUS 2 score
时间窗: Every week after inclusion during 4 weeks
Assessment of pain assessed by the behavioral scale
次要结局
未报告次要终点
研究者
Léa Gouaux
Attachée de recherche clinique
Ecole Supérieur d'Ostéopathie