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Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)

NCT03594266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-07-10

Study results available
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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.

Conditions

  • Chronic Low Back Pain
  • Chronic Leg Pain

Interventions

DEVICE

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

Therapy A stimulation patterns

DEVICE

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

Therapy B stimulation patterns

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Leonardo Kapural, MD · Carolinas Pain Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-03-20
Completion
2020-03-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594266 on ClinicalTrials.gov