Status:
COMPLETED
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitis (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering form DM. The c...
Eligibility Criteria
Inclusion
- Moderate-to-severe PDP in the lower limbs
- The pain intended to treat has been 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:
- Amitriptyline or an other tricyclic antidepressant and/or
- Pregabalin (Lyrica), Gabapentin (Neurontin) or Carbamazepine 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. Each drug is tried for 3 weeks and dose is raised once. 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 change the use of medication during the study.
- Mean pain intensity should be 5 or higher measured on a numeric rating scale (NRS), which will be scored 3 times per day during 4 days according to Jensen.
- Patients age is between 18 and 75 years.
Exclusion
- The patient has had neuromodulation therapy during the month before the intake
- The patient has ever had neuromodulation
- Neuropathic pain prevalent in the upper limbs (NRS above 3)
- Neuropathy or chronic pain of other origin than diabetes mellitus (NRS above 3)
- Addiction: drugs, alcohol (5E/day) and/or medication
- Drugs: cocaine, heroine, marihuana,
- Alcohol: wine, beer, liquor.
- Medication: benzodiazepines, morphine receptor agonists.
- 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, immunosuppressive, etc.)
- Peripheral vascular disease, no palpable peripheral pulsations at the feet (inclusion is possible if pulsations are absent, but ankle/brachial index is between 0.7 and 1.2 in both feet)
- Active foot ulceration
- Life expectancy shorter than 1 year
- Pacemaker
- Local infection or other skin disorders at site of incision
- Psychiatric disorders
- Pregnancy
- Severe cardiac or pulmonary failure (NYHA classification II or higher)
- Unstable blood glucose control (change in HbA1c more than 1,0% (absolute value) in three months prior to inclusion)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00802022
Start Date
January 1 2009
End Date
July 1 2010
Last Update
July 8 2010
Active Locations (1)
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1
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6229 HX