Persistent Spinal Pain Syndrome Type 2BURST-RAPNCT05421273
Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)
A study testing Spinal cord stimulation using passive recharge burst stimulation and Spinal cord stimulation using active recharge burst stimulation in people with Persistent Spinal Pain Syndrome Type 2 and Failed Back Surgery Syndrome, run by Rijnstate Hospital at 6 sites in Netherlands.
Trial summary
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
- What is being tested?
- Spinal cord stimulation using passive recharge burst stimulation and Spinal cord stimulation using active recharge burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesNetherlands
- Study dates
- 16 Feb 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 70 years of age
- At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
- Chronic pain diagnoses as PSPS Type 2 of at least 6 months
- Neurologic exam without marked motor deficit.
- LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
- Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
Show all 9Show fewer
- Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject is able to provide written informed consent
Who cannot join
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- BMI ≥35
- "Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
- Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician
- Previous Neurostimulation therapy
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jan-Willem Kallewaard, PhD contact
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Amsterdam University Medical Hospitals A-UMC
Amsterdam, North Holland, 1105 AZ
Jan-Willem Kallewaard, MD, jkallewaard@rijnstate.nl
Markus Hollmann, PhD
- Recruiting
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
Jan-Willem Kallewaard, PhD, jkallewaard@rijnstate.nl
Jan-Willem Kallewaard, PhD
- Not yet recruiting
Alrijne Hospital
Leiderdorp, South Holland, 2353 GA
Katja Burger, MD, kburger@alrijne.nl
Katja Burger, MD
- Recruiting
Bravis Hospital
Roosendaal, North Brabant, 4708 AE
Lars Elzinga, MD, l.elzinga@bravis.nl
Lars Elzinga, MD
- Recruiting
Elizabeth TweeSteden Hospital
Tilburg, North Brabant, 5042 AD
Jessica De Vries, MD, j.devries@etz.nl
Jessica De Vries, MD
- Recruiting
Diakonessen Hospital
Zeist, Utrecht, 3707 HL
Xander Zuidema, MD, xzuidema@diakhuis.nl
Xander Zuidema, MD
About this study
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain
Read the detailed description
This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.
- Being tested
- Spinal cord stimulation using passive recharge burst stimulation, Spinal cord stimulation using active recharge burst stimulation
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation using passive recharge burst stimulationDevice
Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.
Spinal cord stimulation using active recharge burst stimulationDevice
Active recharge burst is characterized by negative pulses that directly compensate for charge differences.
| Study group | Role | What they receive |
|---|---|---|
| Active recharge burst stimulation | Experimental | Not described Receives: Device: Spinal cord stimulation using active recharge burst stimulation |
| Passive recharge burst stimulation | Experimental | Not described Receives: Device: Spinal cord stimulation using passive recharge burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain catastrophizing score
Measured: 6 months
Secondary outcomes (9)
Numeric pain rating scale
Measured: 3, 6, 12 months
Patient vigilance and awareness questionnaire
Measured: 3, 6, 12 months
Hospital anxiety and depression scale
Measured: 3, 6, 12 months
EQ-5D questionnaire
Quality of life questionnaire
Measured: 3, 6, 12 months
Oswestery disability index
Measured: 3, 6, 12 months
Patient global impression of change
Measured: 3, 6, 12 months
PainDETECT questionnaire
Characterisation of neuropathic pain components
Measured: 3, 6, 12 months
Mean charge per second used
Measures the amount of electrical charge used
Measured: 3, 6, 12 months
Mean charge per hour used
Measures the amount of electrical charge used
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start16 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (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 Persistent Spinal Pain Syndrome Type 2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421273
- Sponsor's protocol ID
- NL75451.091.020
- Acronym
- BURST-RAP
- Status last verified
- Nov 2024
- First submitted
- 8 Jun 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mons MR, Edelbroek C, Zuidema X, Burger K, Elzinga L, de Vries J, van Kuijk S, Joosten EA, Kallewaard JW. Study protocol: Effects of active versus passive recharge burst spinal cord stimulation on pain experience in persistent spinal pain syndrome type 2: a multicentre randomized trial (BURST-RAP study). Trials. 2022 Sep 5;23(1):749. doi: 10.1186/s13063-022-06637-7.
PubMed 36064598
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)
- ClinicalTrials.gov ID
- NCT05421273
- Acronym / sponsor ID
- BURST-RAP / NL75451.091.020
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Jun 2022 (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) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain
Detailed description
This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active recharge burst stimulation | Experimental | Device: Spinal cord stimulation using active recharge burst stimulation |
| Passive recharge burst stimulation | Experimental | Device: Spinal cord stimulation using passive recharge burst stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects between 18 and 70 years of age
- At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
- Chronic pain diagnoses as PSPS Type 2 of at least 6 months
- Neurologic exam without marked motor deficit.
- LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
Key exclusion criteria (8 listed)
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- BMI ≥35
- "Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
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 |
|---|---|---|
| Spinal cord stimulation using passive recharge burst stimulationPassive recharge burst is marked by a recharge pattern that passively compensates for charge differences. | Device | Passive recharge burst stimulation |
| Spinal cord stimulation using active recharge burst stimulationActive recharge burst is characterized by negative pulses that directly compensate for charge differences. | Device | Active recharge burst stimulation |
Primary outcome
Pain catastrophizing score
Time frame: 6 months
9 secondary outcomes
Numeric pain rating scale
Time frame: 3, 6, 12 months
Patient vigilance and awareness questionnaire
Time frame: 3, 6, 12 months
Hospital anxiety and depression scale
Time frame: 3, 6, 12 months
EQ-5D questionnaire
Time frame: 3, 6, 12 months
Oswestery disability index
Time frame: 3, 6, 12 months
Patient global impression of change
Time frame: 3, 6, 12 months
PainDETECT questionnaire
Time frame: 3, 6, 12 months
Mean charge per second used
Time frame: 3, 6, 12 months
Mean charge per hour used
Time frame: 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 36064598Mons MR, Edelbroek C, Zuidema X, Burger K, Elzinga L, de Vries J, van Kuijk S, Joosten EA, Kallewaard JW. Study protocol: Effects of active versus passive recharge burst spinal cord stimulation on pain experience in persistent spinal pain syndrome type 2: a multicentre randomized trial (BURST-RAP study). Trials. 2022 Sep 5;23(1):749. doi: 10.1186/s13063-022-06637-7.
- Individual participant dataSharing planned: No
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Subthreshold SCS or BMT
Failed Back Surgery Syndrome
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.
Jan-Willem Kallewaard, PhD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation using passive recharge burst stimulation and Spinal cord stimulation using active recharge burst stimulation in people with Persistent Spinal Pain Syndrome Type 2 and Failed Back Surgery Syndrome, run by Rijnstate Hospital at 6 sites in Netherlands.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martijn Mons, Msc. (+31433881034, m.mons@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain catastrophizing score (time frame: 6 months). 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 NCT05421273, 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 19 Nov 2024.