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出境医 / 临床实验 / 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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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)


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Paweł Sokal Jan Biziel University Hospital
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Visual Analogue Scale [ Time Frame: 12 months ]
    Change from baseline in VAS for back and leg pain
  • Oswestry Disability Index [ Time Frame: 12 months ]
    Change from baseline in functionality using the ODI score
  • Adverse Events [ Time Frame: 12 months ]
    Number of AE through the study
  • Number of pain medication [ Time Frame: 12months ]
    List of pain medication taken by patient
  • Quality of life scale [ Time Frame: 12months ]
    Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Back and Leg Pain [ Time Frame: 12 months ]
    Visual Analogue Scale
  • Disability [ Time Frame: 12 months ]
    Oswestry Disability Scale
  • Adverse Events [ Time Frame: 12 months ]
    Number of AE through the study
  • Number of medication [ Time Frame: 12months ]
    List of medication
  • Quality of life scale [ Time Frame: 12months ]
    QoL scale assessment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Failed Back Surgery Syndrome
  • CRPS (Complex Regional Pain Syndromes)
Intervention  ICMJE Device: Device: Precision Novi™ system Neurostimulation procedures
SCS with Device: Precision Novi™ system
Other Name: SCS
Study Arms  ICMJE
  • Experimental: scs high-frequency
    high-frequency stimulation
    Intervention: Device: Device: Precision Novi™ system Neurostimulation procedures
  • Experimental: scs tonic
    tonic stimulation
    Intervention: Device: Device: Precision Novi™ system Neurostimulation procedures
  • Experimental: scs burst
    burst stimulation
    Intervention: Device: Device: Precision Novi™ system Neurostimulation procedures
  • Placebo Comparator: scs off
    off stimulation
    Intervention: Device: Device: Precision Novi™ system Neurostimulation procedures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pawel Sokal, Ph.D. +48600954415 pawel.sokal@cm.umk.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957395
Other Study ID Numbers  ICMJE JBUH-NN-SCS-2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
Study Sponsor  ICMJE Jan Biziel University Hospital No 2 in Bydgoszcz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paweł Sokal Jan Biziel University Hospital
PRS Account Jan Biziel University Hospital No 2 in Bydgoszcz
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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