Effect of Spinal Cord Stimulation (SCS) in Painful Diabetic Polyneuropathy (PDP)
Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and significant health resource use. Spinal cord stimulation (SCS) has been used for over 30 years to treat neuropathic pain. Several small clinical studies have shown a beneficial effect of SCS on pain in PDP.
Objective: The primary objective of this study is to investigate whether SCS leads to clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower limbs after 6 months of treatment.
Secondary objectives to investigate 1) the effect of SCS on health related quality of life in PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment.
Study design: the study is a multi centre randomized controlled trial. Study population: Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution).
Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or best (drug) treatment as possible, patients assigned to group 2 will receive best (drug) treatment as possible.
Main study parameters/endpoints: The main study parameter will be the mean pain intensity and/or maximal pain intensity during daytime and/or during night time as measured on a weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6 months of treatment.
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%). Treatment-as-usual related risks are related to the medication used and do not increase due to participation in this study.
Electric Stimulation Therapy
Procedure: Spinal Cord Stimulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a Multicenter Randomised Controlled Trial (PDP 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: 6 months ] [ Designated as safety issue: No ]
- Effect SCS on health related quality of life, quality of sleep, mood, blood glucose control, large/small nerve fibre functions, predictive factors success of SCS treatment, small fibre loss/regeneration, cost-utility and cost-effectiveness [ Time Frame: 6 and 12 months and 5 year follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Spinal Cord Stimulation
Spinal cord stimulation
Procedure: Spinal Cord Stimulation
The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (≥50% relief of pain intensity on a weighted numeric rating scale (NRS) or a score of ≥6 on a seven-point Likert scale (1=very much worse; 7=very much improved) of the PGIC scale for pain and sleep) a definite spinal cord system will be implanted.
Other Name: Medtronic leads and neurostimulator (CE mark 0123)
No Intervention: Treatment as usual
Treatment as usual
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162993
|UMC St. Radboud|
|Nijmegen, Gelderland, Netherlands|
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands|
|Principal Investigator:||Maarten van Kleef, Prf. Dr.||Maastricht University Medical Center|