Who is sponsoring NCT03957395?

NCT03957395 is sponsored by Jan Biziel University Hospital No 2 in Bydgoszcz.

What drugs are being tested in NCT03957395?

Interventions in NCT03957395: Device: Precision Novi™ system Neurostimulation procedures.

What condition does NCT03957395 study?

NCT03957395 studies Failed Back Surgery Syndrome, CRPS (Complex Regional Pain Syndromes).

Is NCT03957395 still recruiting?

NCT03957395 is currently status unknown. Last updated 29 May 2019.

Last reviewed 2019-05-29 · How we verify

NCT03957395

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes

Status unknown NA Last updated 29 May 2019

What this trial tests

NA trial testing Device: Precision Novi™ system Neurostimulation procedures in Failed Back Surgery Syndrome in 50 participants. Status unknown.

Timeline

1 September 2018

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	Jan Biziel University Hospital No 2 in Bydgoszcz
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	1 September 2018
Primary completion	31 December 2021
Estimated completion	31 December 2022
Sites	1 location across Poland

Drugs / interventions tested

Device: Precision Novi™ system Neurostimulation procedures

Conditions studied

Failed Back Surgery Syndrome — all drugs for Failed Back Surgery Syndrome →
CRPS (Complex Regional Pain Syndromes) — all drugs for CRPS (Complex Regional Pain Syndromes) →

Sponsor

Jan Biziel University Hospital No 2 in Bydgoszcz

Who can join

Adults 18 to 80, any sex, with Failed Back Surgery Syndrome or CRPS (Complex Regional Pain Syndromes). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain. The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Spinal cord stimulation for low back pain.
Traeger AC, Gilbert SE, Gilbert SE, Harris IA, et al · · 2023 · cited 44× · PMID 36878313 · DOI 10.1002/14651858.cd014789.pub2
Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial.
Sokal P, Malukiewicz A, Kierońska S, Murawska J, et al · · 2020 · cited 14× · PMID 32878061 · DOI 10.3390/jcm9092810
Survey of Spinal Cord Stimulation Hardware Currently Available for the Treatment of Chronic Pain in the United States.
Clingan JA, Patel A, Maher DP. · · 2020 · cited 9× · PMID 35295690 · DOI 10.3389/fpain.2020.572907

Verify or expand the search:

Other recruiting trials for Failed Back Surgery Syndrome

Currently open trials in the same condition.

NCT07488936 — Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome · recruiting
NCT07050290 — Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level · NA · recruiting
NCT06272539 — Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome · NA · recruiting
NCT05754190 — Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA · recruiting
NCT05421273 — Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syn · NA · recruiting

Other Jan Biziel University Hospital No 2 in Bydgoszcz trials

Trials by the same sponsor.

NCT07190092 — Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment. · NA · recruiting
NCT03948802 — Evaluation of IL-33 in Patients With the Acute Ischemic Stroke · completed
NCT03948399 — The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia. · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03957395 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Jan Biziel University Hospital No 2 in Bydgoszcz
Last refreshed: 29 May 2019

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/NCT03957395.

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