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Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial

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What is being tested

Device: Precision Novi™ system Neurostimulation procedures

Device
Who is being recruted

Autonomic Nervous System Diseases+10

+ Back Pain

+ Nervous System Diseases

From 18 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorJan Biziel University Hospital No 2 in Bydgoszcz
Study ContactPawel Sokal, Ph.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2018

Actual date on which the first participant was enrolled.

Patients with FBSS and CRPS are evaluated for VAS,, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders. All patients undergo percutaneus (1 or 2) 8-contact SCS electrode implantation with trial. All patients are blindly randomized to tonic or burst or high frequency or off stimulation. After 2-week period each participant is adequately switched to another type of stimulation for next 2 weeks. Alltogether crossover takes 8 weeks: four 2-week periods of tonic, burst, HF and off stimulation. At the end of trial period patients are subjected to the mode of stimulation which is the most efficent. The final 2-week stimulation is performed with final renewed evaluation for VAS, amount of taken medications, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders. Follow-up observation will last up to 12 months.

Official TitleComparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
NCT03957395
Principal SponsorJan Biziel University Hospital No 2 in Bydgoszcz
Study ContactPawel Sokal, Ph.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autonomic Nervous System DiseasesBack PainNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainPathologic ProcessesPeripheral Nervous System DiseasesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsComplex Regional Pain SyndromesFailed Back Surgery Syndrome

Criteria

4 inclusion criteria required to participate
FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
Chronic pain as a result of FBSS that exists for at least 6 months
≥ 18 years of age
Written consent of the patient to participate in study procedures.
5 exclusion criteria prevent from participating
Active malignancy
Addiction to any of the following: drugs, alcohol and/or medication
Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
Local infection or other skin disorder at site of surgical incision
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
burst stimulation

Group II

Experimental
high-frequency stimulation

Group III

Placebo
off stimulation

Group IV

Experimental
tonic stimulation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University

Bydgoszcz, PolandOpen Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University in Google Maps
SuspendedOne Study Center