Examination of the Pathological Mechanism of the Complex Regional Pain Syndrome of the Upper Limb in Comparison to Patients With Painful Carpal Tunnel Syndrome and Healthy Subjects - an Explorative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- CPM effect
研究概览
简要总结
This study aims for a better understanding of the pathophysiological mechanisms of the complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the analysis of the heart-rate variability in patients with CRPS and a control-group. We hypothesize decreased conditioned pain modulation, less effects of remote ischemic conditioning and an affection of the heart-rate variability in patients with CPRS.
详细描述
CRPS is an illness which (seriously) affects patients in their daily life activity. The fact that the pathophysiological mechanisms are not well understood yet makes it hard to treat these patients in the right manner.
Possible patho-mechanisms might be microvascular changes and dysfunctions of the inhibitory descending pain system. Furthermore, recent studies showed that CRPS patients have macrovascular changes and a lower blood level of NO on the affected side. This indicates a NO mediated perfusion dysfunction.
Aim of this study is to examine the pathophysiological mechanism of CRPS in relation to healthy subjects and patients with a different type of pain syndrome (carpal tunnel syndrome) on the upper limb.
The investigators try to get a better understanding of the changes in the pain inhibitory system and micro- and macrocirculating blood-systems, as well as of the autonomic system of CRPS-patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average pain in the last 4 weeks ≥ 3 in pain Detect)
- •Pain history < 1 year
- •Exclusion criteria:
- •Bilateral pain on the upper limbs
- •Inadequate knowledge of the german language in speaking and writing
- •Acute psychiatric sickness
- •Polyneuropathy
- •Any added neuropathic sickness on the not affected upper limb sight
- •Intolerable pain during the testing
- •Injuries within the tested areal
- •Acute injuries on the hand
- •Pregnancy
- •Missing informed consent
- •CTS-patients
- •Inclusion Criteria:
- •Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average pain in the last 4 weeks ≥ 3 in pain Detect)
- •Pain history < 1 year
- •Exclusion criteria:
- •Bilateral pain on the upper limbs
- •Inadequate knowledge of the german language in speaking and writing
- •Acute psychiatric sickness
- •Polyneuropathy
- •Any added neuropathic sickness on the not affected upper limb sight
- •Intolerable pain during the testing
- •Injuries within the tested areal
- •Acute injuries on the hand
- •Pregnancy
- •Missing informed consent
- •Healthy subjects
- •Inclusion Criteria:
- •Age > 18 years
- •Written consent
- •Exclusion criteria:
- •Inadequate knowledge of the german language in speaking and writing
- •Current pain
- •Pain within in the last 14 days
- •Any serious internistic medicin
- •Any chronic skin disease
- •Any central neural sickness
- •Polyneuropathy
- •Peripheral nerve lesion within the testing areal
- •Any radiculopathy with permanent pain (in the last 3 months)
- •Any psychiatric sickness
- •Migraine ( at least one attack in the last 24 h)
- •Repeating headache (in the last 3 month on >5 days/month)
- •Taking any analgesics in the last 14 days
- •Taking triptans in the last 24 months
- •Taking any psychotropic's in the last 3 months
- •Any repeated taking of medication, including amber or different psychostimulants (excluding contraceptives)
- •Taking of any prescription and non-prescription drugs (except contraceptives) in the last 7 days or 5 half-life periods(which is always longer) before including into the study
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
CPM effect
时间窗: 60 seconds
Conditioned Pain Modulation measured by the Heat-Cold-Pain Method
Remote Ischemic Conditioning
时间窗: 45 minutes
the perfusion increasing effect after RIC in all groups
次要结局
未报告次要终点
研究者
Christoph Maier, Prof. Dr.
Head of the Dep. of Pain Management
Ruhr University of Bochum