Diabetic Neuropathies Clinical Trial
Official title:
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP Study) A Pilot Study
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%).
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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