Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a Multicenter Randomised Controlled Trial (PDP Study)
Brief Summary: 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.


Options:
A: Arm Label: Evoke SCS with Feedback; Type: EXPERIMENTAL; Interventions: Device: Evoke Spinal Cord Stimulator (SCS) System | Arm Label: Evoke SCS with Conventional; Type: ACTIVE_COMPARATOR; Interventions: Device: Evoke Spinal Cord Stimulator (SCS) System | Intervention Type: DEVICE; Name: Evoke Spinal Cord Stimulator (SCS) System; Assigned to Arm(s): Evoke SCS with Conventional, Evoke SCS with Feedback
B: Intervention Type: DEVICE; Name: Medtronic Manufactured Spinal Cord Stimulators; Assigned to Arm(s): N/A
C: Arm Label: Sequence 1; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Arm Label: Sequence 2; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Intervention Type: DEVICE; Name: High frequency spinal cord stimulation; Assigned to Arm(s): Sequence 1, Sequence 2
D: Arm Label: Spinal Cord Stimulation; Type: EXPERIMENTAL; Interventions: Procedure: Spinal Cord Stimulation | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Spinal Cord Stimulation; Assigned to Arm(s): Spinal Cord Stimulation

Answer: D