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

NCT03957395 | Unknown

• 1 other identifier: JBUH-NN-SCS-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

FBSS; CRPS; SCS; Burst; Tonic; High-frequency

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

scs high-frequency

EXPERIMENTAL

high-frequency stimulation

Device: Device: Precision Novi™ system Neurostimulation procedures

scs tonic

EXPERIMENTAL

tonic stimulation

Device: Device: Precision Novi™ system Neurostimulation procedures

scs burst

EXPERIMENTAL

burst stimulation

Device: Device: Precision Novi™ system Neurostimulation procedures

scs off

PLACEBO COMPARATOR

off stimulation

Device: Device: Precision Novi™ system Neurostimulation procedures

Interventions

Device: Precision Novi™ system Neurostimulation procedures DEVICE

SCS with Device: Precision Novi™ system

Also known as: SCS

scs burst; scs high-frequency; scs off; scs tonic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Jan Biziel University Hospital No 2 in Bydgoszcz: lead

Study Sites (1)

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

Bydgoszcz, 85-168, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Paweł Sokal

  Jan Biziel University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawel Sokal, Ph.D.

CONTACT

+48600954415; pawel.sokal@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Neurosurgery and Neurology

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: September 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)