Failed Back Surgery SyndromeNCT03957395
Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
A study testing Device: Precision Novi™ system Neurostimulation procedures in people with Failed Back Surgery Syndrome and CRPS (Complex Regional Pain Syndromes), run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome, CRPS (Complex Regional Pain Syndromes)
- What is being tested?
- Device: Precision Novi™ system Neurostimulation procedures
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, 85-168
Paweł Sokal, Ph.D., +48600954415, pawel.sokal@cm.umk.pl
Agnieszka Malukiewicz, M.D., +48 604 892 763, agnieszka.malukiewicz@gmail.com
About this study
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
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
Read the 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.
- Being tested
- Device: Precision Novi™ system Neurostimulation procedures
- Keywords
- FBSS, CRPS, SCS, Burst, Tonic, High-frequency
- Medical subject headings
- Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Precision Novi™ system Neurostimulation proceduresDevice
Also called SCS
SCS with Device: Precision Novi™ system
| Study group | Role | What they receive |
|---|---|---|
| scs high-frequency | Experimental | high-frequency stimulation Receives: Device: Device: Precision Novi™ system Neurostimulation procedures |
| scs tonic | Experimental | tonic stimulation Receives: Device: Device: Precision Novi™ system Neurostimulation procedures |
| scs burst | Experimental | burst stimulation Receives: Device: Device: Precision Novi™ system Neurostimulation procedures |
| scs off | Placebo comparator | off stimulation Receives: Device: Device: Precision Novi™ system Neurostimulation procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Change from baseline in VAS for back and leg pain
Measured: 12 months
Oswestry Disability Index
Change from baseline in functionality using the ODI score
Measured: 12 months
Adverse Events
Number of AE through the study
Measured: 12 months
Number of pain medication
List of pain medication taken by patient
Measured: 12months
Quality of life scale
Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
- Investigators
- Paweł Sokal, Principal investigator, Jan Biziel University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957395
- Sponsor's protocol ID
- JBUH-NN-SCS-2018
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03957395
- Acronym / sponsor ID
- JBUH-NN-SCS-2018
- Keywords
- FBSS, CRPS, SCS, Burst, Tonic, High-frequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jan Biziel University Hospital No 2 in BydgoszczUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| scs high-frequency | Experimental | Device: Device: Precision Novi™ system Neurostimulation procedureshigh-frequency stimulation |
| scs tonic | Experimental | Device: Device: Precision Novi™ system Neurostimulation procedurestonic stimulation |
| scs burst | Experimental | Device: Device: Precision Novi™ system Neurostimulation proceduresburst stimulation |
| scs off | Placebo comparator | Device: Device: Precision Novi™ system Neurostimulation proceduresoff stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Precision Novi™ system Neurostimulation proceduresAlso: SCSSCS with Device: Precision Novi™ system | Device | scs burst, scs high-frequency, scs off, scs tonic |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Derived from this study: PubMed 34854473O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Sokal principal investigator
Jan Biziel University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Precision Novi™ system Neurostimulation procedures in people with Failed Back Surgery Syndrome and CRPS (Complex Regional Pain Syndromes), run by Jan Biziel University Hospital No 2 in Bydgoszcz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawel Sokal, Ph.D. (+48600954415, pawel.sokal@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.