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

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

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 Overview

• Status: Unknown
• Conditions: CRPS (Complex Regional Pain Syndromes); Failed Back Surgery Syndrome
• Intervention / Treatment: Device: Device: Precision Novi™ system Neurostimulation procedures

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pawel Sokal, Ph.D.; Phone Number: +48600954415; Email: pawel.sokal@cm.umk.pl

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-168
    • Recruiting
    • Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
    • Contact: Paweł Sokal, Ph.D.; Phone Number: +48600954415; Email: pawel.sokal@cm.umk.pl
    • Contact: Agnieszka Malukiewicz, M.D.; Phone Number: +48 604 892 763‬; Email: agnieszka.malukiewicz@gmail.com
    • Sub-Investigator: Agnieszka Malukiewicz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: scs high-frequency; high-frequency stimulation	Device: Device: Precision Novi™ system Neurostimulation procedures; SCS with Device: Precision Novi™ system; Other Names: SCS
Experimental: scs tonic; tonic stimulation	Device: Device: Precision Novi™ system Neurostimulation procedures; SCS with Device: Precision Novi™ system; Other Names: SCS
Experimental: scs burst; burst stimulation	Device: Device: Precision Novi™ system Neurostimulation procedures; SCS with Device: Precision Novi™ system; Other Names: SCS
Placebo Comparator: scs off; off stimulation	Device: Device: Precision Novi™ system Neurostimulation procedures; SCS with Device: Precision Novi™ system; Other Names: SCS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jan Biziel University Hospital No 2 in Bydgoszcz
• Investigators: Principal Investigator: Paweł Sokal, Jan Biziel University Hospital

Publications and helpful links

General Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: CRPS; SCS; FBSS; High-frequency; Burst; Tonic
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Back Pain; Syndrome; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders; Failed Back Surgery Syndrome
• Other Study ID Numbers: JBUH-NN-SCS-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No