Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
Primary Purpose
Failed Back Surgery Syndrome, CRPS (Complex Regional Pain Syndromes)
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Device: Precision Novi™ system Neurostimulation procedures
Sponsored by
About this trial
This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring FBSS, CRPS, SCS, Burst, Tonic, High-frequency
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
scs high-frequency
scs tonic
scs burst
scs off
Arm Description
high-frequency stimulation
tonic stimulation
burst stimulation
off stimulation
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Change from baseline in VAS for back and leg pain
Oswestry Disability Index
Change from baseline in functionality using the ODI score
Adverse Events
Number of AE through the study
Number of pain medication
List of pain medication taken by patient
Quality of life scale
Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
Secondary Outcome Measures
Full Information
NCT ID
NCT03957395
First Posted
May 17, 2019
Last Updated
May 27, 2019
Sponsor
Jan Biziel University Hospital No 2 in Bydgoszcz
1. Study Identification
Unique Protocol Identification Number
NCT03957395
Brief Title
Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jan Biziel University Hospital No 2 in Bydgoszcz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome, CRPS (Complex Regional Pain Syndromes)
Keywords
FBSS, CRPS, SCS, Burst, Tonic, High-frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
scs high-frequency
Arm Type
Experimental
Arm Description
high-frequency stimulation
Arm Title
scs tonic
Arm Type
Experimental
Arm Description
tonic stimulation
Arm Title
scs burst
Arm Type
Experimental
Arm Description
burst stimulation
Arm Title
scs off
Arm Type
Placebo Comparator
Arm Description
off stimulation
Intervention Type
Device
Intervention Name(s)
Device: Precision Novi™ system Neurostimulation procedures
Other Intervention Name(s)
SCS
Intervention Description
SCS with Device: Precision Novi™ system
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Change from baseline in VAS for back and leg pain
Time Frame
12 months
Title
Oswestry Disability Index
Description
Change from baseline in functionality using the ODI score
Time Frame
12 months
Title
Adverse Events
Description
Number of AE through the study
Time Frame
12 months
Title
Number of pain medication
Description
List of pain medication taken by patient
Time Frame
12months
Title
Quality of life scale
Description
Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
Time Frame
12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pawel Sokal, Ph.D.
Phone
+48600954415
Email
pawel.sokal@cm.umk.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Sokal
Organizational Affiliation
Jan Biziel University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paweł Sokal, Ph.D.
Phone
+48600954415
Email
pawel.sokal@cm.umk.pl
First Name & Middle Initial & Last Name & Degree
Agnieszka Malukiewicz, M.D.
Phone
+48 604 892 763
Email
agnieszka.malukiewicz@gmail.com
First Name & Middle Initial & Last Name & Degree
Agnieszka Malukiewicz
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34854473
Citation
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.
Results Reference
derived
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Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
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