Clinical Trial: Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy

Brief Summary: A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).

Detailed Summary: This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
Sponsor: Dr med. Paolo Maino Viceprimario Anestesiologia

Current Primary Outcome: Change in pain intensity assessed by Numeric Rating Scale. [ Time Frame: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation. ]

Four assessments/day for 5 consecutive days around the intended measurement timepoint


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ospedale Regionale di Lugano

Dates:
Date Received: April 15, 2015
Date Started: April 2015
Date Completion: April 2017
Last Updated: April 6, 2016
Last Verified: April 2016