Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a multicenter Randomised Controlled Trial (PDP study)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• Moderate-to-severe PDP in the lower limbs
o The pain intended to treat has been present for more than 12 months
o Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories:
* Amitriptylin or an other tricyclic antidepressant and/or
* Pregabalin (Lyrica®) or Gabapentin (Neurontin®) and/or
* Duloxetine (Cymbalta®) and/or
* Tramadol or strong opioids
Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Starting dosage was based on individual patient characteristics. Each drug was tried for at least 3 weeks and dose 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. Use of opioids during the study is not allowed.
• Mean pain intensity during daytime and/or night time should be 5 or higher measured on a numeric rating scale (NRS). Pain during daytime will be scored 3 times per day during for 4 days according to Jensen.
• Patient*s age is between 18 and 80 years.
• It is necessary that patients which use anti coagulation, especially coumarin derivatives, can stop for 10 days around the procedure. This will be authorized by the treating physician of the patient. There will be no bridging to heparin.

Exclusion Criteria

• The patient has had neuromodulation therapy during the month before the intake
• Neuropathic pain is most prevalent in the upper limbs (NRS>3)
• Neuropathy or chronic pain of other origin than diabetes mellitus (NRS> 3)
• Use of opioids
• Addiction: drugs, alcohol (> 5E / day) and/or medication
o Drugs: cocaine, heroine, marihuana.
o Alcohol: wine, beer, liquor (max 5E / day)
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 > prednisolone 10 mg, immunodepressiva, etc.)
• 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 problems potentially interfering with cooperation in the study
• Pregnancy
• Severe cardiac or pulmonary failure (> NYHA classification II)
• Unstable blood glucose control (change in HbA1c>1,0% in three months prior to inclusion)