Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (SCS)
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 current available medication often provides insufficient pain relief and/or has unacceptable side effects. Spinal cord stimulation (SCS) has been used for over 30 years to treat neuropathic pain. Various small clinical studies have shown a beneficial effect of SCS on pain in PDP.
Objective: This study is a preparation to a RCT to investigate whether SCS is a good indication in patients which suffer from pain with moderate-to-severe PDP in the lower limbs. The main objective of this study is whether SCS leads to sufficient pain relief and to obtain insight into the working mechanism of SCS. The hypothesis is that the effect SCS is most effective in patients without major sensory deficits. Furthermore, practical feasibility of the test procedures described in the study protocol will be examined, including the questionnaires to be filled out by the patient. Also, technical feasibility of SCS will be investigated. Besides the feasibility, the possibility of predicting successful pain relief by SCS by classifying patients according to the Michigan Diabetic Neuropathy Score will be assessed. Furthermore, possible other predictors for successful pain relief by SCS will be defined. Study design: the study is a pilot study in preparation to a RCT to investigate the effect of spinal cord stimulation on pain in moderate-to-severe PDP patients.
Study population: patients suffering from moderate-to-severe PDP in the lower limbs as diagnosed by clinical symptoms and supported by the Michigan Diabetic Neuropathy Score.
Intervention: patients will receive 2 weeks of trial stimulation and best (drug) treatment as usual.
Main study parameters/endpoints: Main study parameter is the pain score as measured by a numeric rating scale (NRS) according to Jensen and a Patient Global Impression of Change for pain measured on a 7-point Likert scale.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid collection (5%).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP Study) A Pilot Study|
- Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. [ Time Frame: Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- The practical- and technical feasibility of the procedures, predicting successful pain relief by SCS by classifying patients according to the MDNS. Define possible other predictors for successful pain relief. [ Time Frame: Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Device: spinal cord stimulation
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802022
|Maastricht University Hospital|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Principal Investigator:||Maarten van Kleef, prof. dr.||Maastricht University Hospital|