Pain due to diabetic nerve damage painful distal symmetrical diabetic polyneuropathy
Conditions
Interventions
The intervention is spinal cord stimulation.
Sponsors
Anesthesiologie-Pijnbestrijding
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 NYHA classification II) • Unstable blood glucose control (change in HbA1c>1,0% in three months prior to inclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be the mean pain intensity during daytime and/or mean pain intensity during night time as measured on a weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of life will be measured by EQ-5D, MOS SF-36 and the modified BPI Short Form for diabetic peripheral neuropathy; 2) Quality of sleep will be measured by the MOS sleep scale; 3) The effect of SCS on mood will be measured by the BDI; 4) The effect of SCS on blood glucose control will be investigated by measuring HbA1c; 5) To measure the effect of SCS on large and small neurofibre functions the modified INCAT sensory sum score (md ISS), Contact Heat Evoked Potentials Stimulator (CHEPS), and Somato-sensory evoked potentials (SSEP) measurements will be performed; 6) The effect of SCS on small fibre loss and possible regeneration will be investigated by skin biopsy; 7) The effect of SCS on activities-of-daily-living will be measured with an accelerometer (activPALTM); 8) All baseline parameters will be analyzed for their predictive value for the success or failure of SCS treatment in PDP; e.g. pain scores, NPS, EuroQol-5D, MOS SF-36, BDI, Michigan Diabetic Neuropathy Score (MDNS) , md INCAT sensory sum score, CHEPS, SSEP, HbA1c and skin biopsy; 9) Costs will be measured through the hospital registration and by means of a standardized cost-questionnaire and the EQ-5D; 10) The long term follow-up will measured for 5 years, twice each year, by using the same questionnaire and pain dairy. | — |
Countries
Netherlands
Outcome results
None listed