MedTrace Logo

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

NCT03957395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-05-29

No results posted yet for this study

Summary

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

Conditions

  • Failed Back Surgery Syndrome
  • CRPS (Complex Regional Pain Syndromes)

Interventions

DEVICE

Device: Precision Novi™ system Neurostimulation procedures

SCS with Device: Precision Novi™ system

Sponsors & Collaborators

  • Jan Biziel University Hospital No 2 in Bydgoszcz

    lead OTHER

Principal Investigators

  • Paweł Sokal · Jan Biziel University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Poland

Study Locations

More Related Trials

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 NCT03957395 on ClinicalTrials.gov