NL-OMON36334
Completed
Not Applicable
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a multicenter Randomised Controlled Trial (PDP study) - PDP study
Anesthesiologie-Pijnbestrijding0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Anesthesiologie-Pijnbestrijding
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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