跳至主要内容
临床试验/NCT03939377
NCT03939377已完成不适用

Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
VAS (Visual Analog Scale) evaluation (0 to 100)

研究概览

简要总结

The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patient (age> 18) male or female
  • Patient hospitalized or admitted to a day hospital that can be followed
  • EVA between 40/100 and 60/100
  • Signed informed consent

排除标准

  • Patients requiring a modification of analgesic molecule during the study.
  • Clinical stability of the patient estimated during the duration of the study.

结局指标

主要结局

VAS (Visual Analog Scale) evaluation (0 to 100)

时间窗: day 6

Evolution of the score of the Visual Analogue Scale (VAAS) on 100 between D0 and D6 and D0 and D1, D0 and D2, D0 and D3, D0 and D4, D0 and D5

次要结局

  • Dose of analgesic (g)(day 6)
  • QLQ (Quality of life questionnaire) C15 Pal score(days 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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