Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
Unknown statusNot applicableNCT03957395
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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)
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
Study details
- Official title
- 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
- Conditions
- Failed Back Surgery Syndrome
- CRPS (Complex Regional Pain Syndromes)
- Interventions
- Device: Device: Precision Novi™ system Neurostimulation procedures
- Sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Start date
- 2018-09-01
- Primary completion
- 2021-12-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy 2. Chronic pain as a result of FBSS that exists for at least 6 months 3. ≥ 18 years of age 4. Written consent of the patient to participate in study procedures. Exclusion Criteria: 1. Active malignancy 2. Addiction to any of the following: drugs, alcohol and/or medication 3. 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 4. Local infection or other skin disorder at site of surgical incision 5. Pregnancy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03957395