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

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ClinicalTrials.gov Identifier: NCT03957395
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz

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


Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome CRPS (Complex Regional Pain Syndromes) Device: Device: Precision Novi™ system Neurostimulation procedures Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: scs high-frequency
high-frequency stimulation
Device: Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system
Other Name: SCS

Experimental: scs tonic
tonic stimulation
Device: Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system
Other Name: SCS

Experimental: scs burst
burst stimulation
Device: Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system
Other Name: SCS

Placebo Comparator: scs off
off stimulation
Device: Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system
Other Name: SCS




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 12 months ]
    Change from baseline in VAS for back and leg pain

  2. Oswestry Disability Index [ Time Frame: 12 months ]
    Change from baseline in functionality using the ODI score

  3. Adverse Events [ Time Frame: 12 months ]
    Number of AE through the study

  4. Number of pain medication [ Time Frame: 12months ]
    List of pain medication taken by patient

  5. Quality of life scale [ Time Frame: 12months ]
    Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957395


Contacts
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Contact: Pawel Sokal, Ph.D. +48600954415 pawel.sokal@cm.umk.pl

Locations
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Poland
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University Recruiting
Bydgoszcz, Poland, 85-168
Contact: Paweł Sokal, Ph.D.    +48600954415    pawel.sokal@cm.umk.pl   
Contact: Agnieszka Malukiewicz, M.D.    +48 604 892 763‬    agnieszka.malukiewicz@gmail.com   
Sub-Investigator: Agnieszka Malukiewicz         
Sponsors and Collaborators
Jan Biziel University Hospital No 2 in Bydgoszcz
Investigators
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Principal Investigator: Paweł Sokal Jan Biziel University Hospital

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Responsible Party: Pawel Sokal, Head of Department of Neurosurgery and Neurology, Jan Biziel University Hospital No 2 in Bydgoszcz
ClinicalTrials.gov Identifier: NCT03957395     History of Changes
Other Study ID Numbers: JBUH-NN-SCS-2018
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz:
FBSS
CRPS
SCS
Burst
Tonic
High-frequency

Additional relevant MeSH terms:
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Syndrome
Chronic Pain
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Postoperative Complications
Back Pain