Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP study) A pilot study - PDP Study

Academisch Ziekenhuis Maastricht0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- 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

•- 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
•- Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to or higher than prednisolone 10 mg, immunosuppressiva)
•- Peripheral vascular disease without palpable peripheral pulses at both feet (inclusion is possible if pulses are absent, but ankle brachial index is between 0.7 and 1.2 in both feet)
•- Active foot ulceration
•- Life expectancy < 1 year
•- Pacemaker
•- Local infection or other skin disorders at site of incision
•- Psychiatric disorders
•- Pregnancy
•- Severe cardiac or pulmonary failure (NYHA classification > II)
•- Unstable blood glucose control (change in HbA1c > 1,0% (absolute value) in three months prior to inclusion)

发起方