CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components +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/NCT03594266
NCT03594266N/ACompleted
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Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)

Biotronik, Inc.·interventional·Posted Jul 20, 2018·Updated Jul 10, 2023

In Brief

A clinical study evaluating Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components and Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components for Chronic Low Back Pain and Chronic Leg Pain. Completed, enrolled 136 participants across 18 sites.

Detailed Summary

A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain, Chronic Leg Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 20, 2018
Enrollment StartAug 1, 2018
Primary CompletionMar 20, 2020
Study CompletionMar 27, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.0 years ago

Interventions

Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated componentsdevice

Therapy A stimulation patterns

Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated componentsdevice

Therapy B stimulation patterns