NL-OMON32639
已完成
不适用
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP study) A pilot study - PDP Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Pain due to diabetic nerve damage
- 发起方
- Academisch Ziekenhuis Maastricht
- 入组人数
- 20
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Moderate\-to\-severe PDP in the lower limbs due to diabetes mellitus type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution).
- •\- The pain intended to treat has to be present for more than 12 months.
- •\- Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side\-effects) with drugs from the following drug categories: 1\)Amitriptylin or an other tricyclic antidepressant and/or 2\) Pregabalin (Lyrica) or Gabapentin (Neurontin) and/or 3\) Duloxetine (Cymbalta) and/or 4\) Tramadol or strong opioids
- •Patients were treated with three drugs fromk the above mentioned drug categories and followed the treatment algorithm for painful diabetic neuropathy according tot Jensen. Starting dosage was based on individual patient characteristics. Each drug was tried for 3 weeks and dosage was raised once if possible. By insufficient pain relief and/or unacceptable side effects, the drug treatment was stopped. Patients reached a steady\-state in medication use and it is not allowed to increase dosage during the study.
- •\- Mean pain intensity should be 5 or higher measured on an numeric rating scale (NRS) which will be scored 3 times per day for 4 days
- •\- Patients' age is between 18 and 75 years
排除标准
- •\- The patient has had neuromodulation therapy during the month before inclusion
- •\- Neuropathic pain most prevalent in the upper limbs (NRS \>3\)
- •\- Neuropathy or chronic pain of other origin than diabetes mellitus (NRS \>3\)
- •\- Addiction: drugs, alcohol (5E/day) and/or medication
- •o Drugs: cocaine, heroine, marihuana.
- •o Alcohol: wine, beer, liquor.
- •o Medication: benzodiazepines.
- •\- Insufficient cooperation from the patient (little motivation, understanding or
- •communication)
- •\- Blood clotting disorder
结局指标
主要结局
未指定
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