Pain Clinical Trial
Official title:
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a Multicenter Randomised Controlled Trial (PDP Study)
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.
n/a
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