Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Thermal induced heat pain
研究概览
简要总结
Study comparing pain intensity and discomfort in patients with Parkinson´s disease and healthy controls during inducement of mechanical, thermal, and chemical experimental pain
详细描述
Project: Inducing experimental muscle pain in healthy volunteers, patients with Parkinson's disease in levodopa treatment, and patients with Parkinson's disease with deep brain stimulation treatment
Research team:
- Andrea S. Poulsen (PI), PhD-student, AU
- Sophie Rosenkjær, PhD-student, AU
- Lene Vase, Professor, AU
- Nanna B. Finnerup, Professor, AUH
- Mette Møller, Leading doctor, AUH
- Erisela Qerama Montvilas, Clinical lector, AUH
- Jan Rosner, Post-doc, AUH
Objective: Comparing induced pain levels in (1) healthy volunteers, (2) patients with Parkinson's disease in levodopa treatment, and (3) patients with Parkinson's disease with deep brain stimulation treatment
Participants: 21 healthy volunteers, 21 patients with Parkinson's disease in levodopa treatment, and 21 patients with Parkinson's disease with deep brain stimulation treatment will be recruited from the Department of Neurology at Aarhus University Hospital. Furthermore, recruitment sheets will be posted at Aarhus University Hospital, at Parkinsonforeningen's webpage (https://www.parkinson.dk/) and newsletter and in local newspapers. A power calculation for a Wilcoxcon-Mann-Whitney rank sum test (Three groups) determine 21 in three test groups is adequate (effect size= 0.8; 1-β=.80; α=.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group healthy volunteers: healthy subjects with no PD diagnosis
- •Group PD patients levodopa: Include PD patients treated with levodopa
- •Group PD patients DBS: Include PD patients with DBS
排除标准
- •Known other neurological or medical disorders (e.g., stroke, neuropathy, diabetes) or other disorders with expected influence on experimental pain
- •Known dementia (a score <24 on the MoCA)
- •Known untreated depression (a score ≥15 on the Beck Depression Inventory)
- •Unable to cooperate
- •Treated with painkillers except paracetamol and NSAID (except if pain and treatment is ad-equately stable as evaluated by a doctor)
研究组 & 干预措施
Experimental pain
Experimental pain
干预措施: inducement of experimental pain (Other)
结局指标
主要结局
Thermal induced heat pain
时间窗: Immediately after assessment of ongoing pain (15 minutes)
Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
Ongoing pain (Clinical pain in daily life)
时间窗: After assessment of motor response latencies measure (15 minutes)
Intensity and discomfort of ongoing pain in gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle will be assessed by use of 11- point Numeric Rating Scale (NRS)
Ongoing pain (Pain in PD)
时间窗: After assessment of motor response latencies measures (15 minutes)
Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)
Mechanical induced pain
时间窗: Immediately after assessment of thermal induced heat pain (15 minutes)
Mechanical pain thresholds and suprathresholds will be measured by use of a handhold pressor algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe placed on test muscle (gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle in a randomized order)
Chemical induced pain
时间窗: Immediately after assessment of mechanical pain (15 minutes)
Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)
Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)
时间窗: After assessment of motor response latencies measures (15 minutes)
Sensory and affective verbal descriptions of pain and patient drawings of pain size and distribution will be measured by use of the short-form McGill Pain Questionnaire (SF-MPQ).
次要结局
- Motor response latencies measure(Prior to assessment of ongoing pain (3 minutes))