CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
StimRouter - active stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01592344
NCT01592344N/ACompleted
CompareCT.gov

Prospective, Multi-Center, Randomized, Double-Blinded, Study to Assess Safety and Efficacy of the Bioness® StimRouter™ Neuromodulation System in Patients With Chronic Pain of Peripheral Nerve Origin

Bioness Inc·interventional·Posted May 7, 2012·Updated Apr 11, 2016

In Brief

A clinical study evaluating StimRouter - active stimulation and StimRouter - Control for Chronic Pain. Completed, enrolled 94 participants across 13 sites.

Detailed Summary

The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2012
Enrollment StartApr 1, 2012
Primary CompletionOct 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.2 years ago

Interventions

StimRouter - active stimulationdevice

The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 100-250 µsec * Pulse Rate: 50-100 Hz * Intensity: 0-30mA Time Settings * Constant Stim: On * Total Time: 6 hour

StimRouter - Controldevice

The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 200 µsec * Pulse Rate: 1 Hz * Intensity: 0 mA Time Settings * Constant Stim: On * Total Time: 6 hour