Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Change of the intensity of pain perception
研究概览
简要总结
This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.
详细描述
A large proportion of patients with Parkinson's disease suffer of chronic pain directly related to the disease. The management of painful symptoms is difficult and currently, there is no commonly admitted guidelines.
Several studies have shown the efficacy of Erickson hypnosis to reduce the perception of chronic pain in different conditions. This efficacy has never been tested in Parkinson's disease.
The objective of this study is to assess the efficacy of Erickson hypnosis protocol, compared to usual care, for the management of Parkinson's disease-related chronic pain.
The study team assume that Erickson hypnosis will be more efficient than usual care to reduce perceived chronic pain. They also assume that regular practice of autohypnosis will contribute to long-term efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •18 to 80 years old
- •idiopathic Parkinson's disease
- •without neurological co-morbidity
- •Suffering from chronic pain (for at least 3 months), related to Parkinson's disease
- •Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain
- •antiparkinsonian, analgesic and psychotropic treatments stable for 1-month
- •having a health insurance
- •signed informed consent form
排除标准
- •Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome
- •Early untreated patient
- •Patient with acute intercurrent pain
- •Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.)
- •Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) <24
- •Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2> 1)
- •Patient with a apathy (MDS-UPDRS 1.5> 1)
- •Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2> 1)
- •Patient under the protection of adults
- •Pregnant or lactating woman
结局指标
主要结局
Change of the intensity of pain perception
时间窗: At baseline and 2 months after
Measure of the intensity of pain perception by VAS at the baseline visit and at the post-treatment visit (2 months later). The difference between both values will allow to calculate a variation index.
次要结局
- Change of the score at the Brief Pain Inventory(At baseline and 2 months after)
- Change of the score at the McGill Pain Questionnaire(At baseline and 2 months after)
- Change of the score at the Beck Depression Inventory(At baseline and 2 months after)
- Change of the score at the Fatigue Severity Scale(At baseline and 2 months after)
- Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)(At baseline and 2 months after)
- Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)(At baseline and 2 months after)
- Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)(At baseline and 2 months after)
- Change in the dose of analgesic treatments(At baseline and 2 months after)
- Change in the dose of psychotropic medications(At baseline and 2 months after)
- Change of the score at MDS-UPDRS(At baseline and 2 months after)