Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
CompletedNAResults postedLast updated 10 July 2023
What this trial tests
NA trial testing Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components in Chronic Low Back Pain in 136 participants. Completed in 27 March 2020.
18 and older, any sex, with Chronic Low Back Pain or Chronic Leg Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS TherapyPrimary· Baseline and in-office visit 3, average of 21 days
The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
Group
Value
95% CI
Therapy A Spinal Cord Stimulation Parameter Set
-4.3
± 0.47
Therapy B Spinal Cord Stimulation Parameter Set
-4.7
± 0.48
Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)Primary· Baseline and in-office visit 3, average of 21 days
The purpose of primary endpoint 2 is to provide an inter-therapy comparison of change since baseline in Numerical Rating Scale (NRS) for pain (overall). Primary endpoint 2 analyses includes all participants included in primary endpoint 1 analyses. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.
Group
Value
95% CI
Therapy A Spinal Cord Stimulation Parameter Set
-4.3
± 0.47
Therapy B Spinal Cord Stimulation Parameter Set
-4.7
± 0.48
Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS TherapySecondary· In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
The evaluation of secondary endpoint 1 will be based on Numerical Rating Scale (NRS) for overall pain experienced over the past 24 hours (scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain) obtained at conclusion of commercial trial compared to NRS for overall pain at the final study testing visit
Group
Value
95% CI
Therapy A Spinal Cord Stimulation Parameter Set
1.0
± 0.53
Therapy B Spinal Cord Stimulation Parameter Set
0.3
± 0.32
Investigational Device-related Adverse Event-free RateSecondary· Baseline and in-office visit 3, average of 21 days
The evaluation of secondary endpoint 2 will be based on the number of subjects free from investigational device-related adverse events assessed at in-office visit 1 (randomization visit) through in-office visit 3 (study completion). The investigational device-related adverse event-free rate was pre-defined within the protocol as the overall rate from all implanted Prospera SCS devices, regardless of randomized therapy output setting (Therapy A or Therapy B).
Group
Value
95% CI
Subjects Provisionally Enrolled
76
Adverse events — posted to ClinicalTrials.gov
Time frame: 21 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
· NA
· recruiting
NCT07415941 — MBM and taVNS for Low Back Pain and Depressive Symptoms
· NA
· recruiting
NCT06419439 — Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
· Phase 2
· recruiting
NCT07241559 — Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided 5% Dextrose Injection in Chronic Low Back Pain
· NA
· recruiting
NCT07132762 — The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Bac
· NA
· recruiting
Other Biotronik, Inc. trials
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NCT03884608 — Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biotronik, Inc.
Last refreshed: 10 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03594266.