Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- evaluation of changes in the mean intensity of chronic pain
研究概览
简要总结
Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). the present study proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.
详细描述
Parkinson's disease (PD) is a neurodegenerative disease characterized by the destruction of specific neurons population involved in movement control. Pain is one of the non-motor symptoms still poorly known and misdiagnosed. In addition to this fact, its management is complex. At present, the medical community has no effective solution to reduce pain to an acceptable level in terms of intensity or frequency.
Pain is a personal, subjective experience with an affective and cognitive dimension. The context and its psychological impact can amplify as well as alleviate the pain. Thus, non-pharmacological treatment (NPT) that influence the psychological state (mood, level of stress, ...) can also modulate the pain experience through the brain matrix of pain. Among them, foot reflexology, which by stimulating reflex zones located on the feet, makes it possible to modify the perception of the pain and to modify the subjective / emotional valence of the pain. In this study, we propose to evaluate this technique, by postulating that it should reduce the chronic pain of patients with Parkinson's disease.
This project is innovative and original in two dimensions : On the one hand, the pain of patients in PD is still often underestimated, there is in the mere fact of devoting a study a real dynamic of change in the consideration of the patients concerned and in the management of this non-motor symptom. On the other hand, the increasing use of NPT requires that clinical studies be conducted. To date, it is clear that very few or no reliable studies have been conducted on the subject. We wish to develop complementary non-pharmacological management to provide concrete help to Parkinson's patients and thus initiate the scientific validation of NPT as recommended by the High Authority of Health.
The study hypothesize that through a comparison of the evolution of different parameters, quantitative and qualitative, this study will allow to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.
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
- Double (Participant, Outcomes Assessor)
盲法说明
placebo is a traditional massage instead of a intervention reflexology massage
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an age egal at 18 years old or more,
- •Patient presenting a little fluctuating Parkinson's disease attested by a score ≤ 2 on the MDS UPDRS IV,
- •Patients with chronic pain for at least 3 months with a VAS ≥ 4
- •Patients whose anti-parkinsonian treatment is stable throughout the duration of the study and at least for 4 weeks.
排除标准
- •Patients with cognitive impairment defined by an MOCA<25
- •Patient presenting contraindication to carrying out the MRI examination
- •Patient refusing to be informed of any abnormality detected on brain MRI
- •Patient included in a clinical trial that potentially interferes with the objective of the study,
- •Patient resistant to foot massage,
- •Patient having benefited from a Foot reflexology session in the last 6 months, - Patient presenting skin lesions in the feet,
- •Patient having a recent fracture in the feet,
- •Patient having an history of phlebitis less than 3 months and history of deep vein thrombosis.
结局指标
主要结局
evaluation of changes in the mean intensity of chronic pain
时间窗: Day 1 and week 12
Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)
次要结局
- connectivity of brain networks(Day 1 and week 12)
- evaluation of the threshold of perception of subjective warm pain(Day 1, week 9 and week 12)
- evaluation of anxiety and depression(Day 1 and week 12)
- evaluation of the change in pain on the VAS(Day 1, week 3, week 6, week 9 and week 12)
- evaluation of the consumption of analgesics(Day 1, week 3, week 6, week 9 and week 12)
- evaluation of change in chronic pain(Day 1 and week 12)