Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Polyneuropathies
Study type: Interventional

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 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%).
    


Intervention name(s): spinal cord stimulation
Intervention type(s): Device
Intervention description(s): The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (50% of more pain reduction)a definite spinal cord system will be implanted.
Other intervention name(s): Medtronic leads and neurostimulator (CE mark 0123)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic neuropathies; electric stimulation therapy