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

CompletedNot applicableNCT03594266
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Conditions
Interventions
  • Device: Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
  • Device: Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
Sponsor
Biotronik, Inc.
Start date
2018-08-01
Primary completion
2020-03-20
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
18

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age greater than or equal to 18 years * Able to understand the nature of the study and provide written informed consent * Able to read, understand, and speak English * Willing and able to comply with all study requirements, including all required procedures, phone calls and study visits * Planned to undergo a commercial SCS trial of standard duration for the treatment of low back and/or leg pain with a commercially available SCS system as prescribed by a physician(s) according to FDA approved indications for use * Planned utilization of preoperative antibiotics for SCS commercial trial * Planned placement of two eight-electrode SCS trial leads (or at least one 16- electrode SCS trial lead) using a suitable technique for an extended trial (e.g. tunneling approach of a minimum of 3-4 cm, or buried lead trial) with at least one lead covering the T8 or T9 vertebral level * Incoming Numerical Rating Scale (NRS) for pain (overall) of at least 6 (collected prior to the commercial trial) * Passed psychological evaluation * Negative MRSA screening result * Negative MSSA screening result or documentation of subsequent decolonization routine if MSSA positive * For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 7.5% Exclusion Criteria: * Enrolled in any investigational SCS stimulation trial, for which the SCS system is not commercially available * Presence of any life-threatening, underlying illness separate from their indication for SCS therapy * Patients reporting pregnancy at the time of enrollment * Patients with poor compliance for pain management regimen * Patients currently involved in an active workers compensation claim and/or active litigation related to injury associated with indication for SCS * Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to baseline data collection * Patients with an implanted pacemaker, defibrillator, or other medical contraindications for SCS therapy * Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator * Patients immunocompromised and/or at high risk for infection * Patients with morphine equivalent dose \> 120 units * Patients with documented history of allergic respo…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03594266