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

Failed Back Surgery Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957395
• Other study ID #: JBUH-NN-SCS-2018
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2019
• Source: Jan Biziel University Hospital No 2 in Bydgoszcz
• Contact: Pawel Sokal, Ph.D.
• Phone: +48600954415
• Email: pawel.sokal[@]cm.umk.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• CRPS (Complex Regional Pain Syndromes)
• Failed Back Surgery Syndrome
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system

Locations

Country	Name	City	State
Poland	Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Jan Biziel University Hospital No 2 in Bydgoszcz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Change from baseline in VAS for back and leg pain	12 months
Primary	Oswestry Disability Index	Change from baseline in functionality using the ODI score	12 months
Primary	Adverse Events	Number of AE through the study	12 months
Primary	Number of pain medication	List of pain medication taken by patient	12months
Primary	Quality of life scale	Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)	12months