Neuropathic PainNCT01486108
Burst Spinal Cord Stimulation for Neuropathic Pain
A study testing dorsal column stimulator in people with Neuropathic Pain, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- dorsal column stimulator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Sep 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in this study must meet the following inclusion criteria:
- Patients able to provide informed consent to participate in the study;
- Patient is between the age of 18 and 75;
- Patient has Failed Back Surgery Syndrome;
- Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
- Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
- Patient agrees not to add or increase medication throughout the randomization trial period of the study;
- Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.
Who cannot join
- A patient will be excluded from participation in this study if they meet any one of the following criteria:
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
- Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
- Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- Patient currently participating in another clinical study;
- Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
- Patient is not willing to maintain current medication regimen;
- Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.
Read the detailed description
Patients receive three type of stimulation (burst, tonic and sham). We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)
- Conditions
- Neuropathic Pain
- Being tested
- dorsal column stimulator
- Keywords
- tonic, burst and placebo stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorsal column stimulatorProcedure or surgery
Also called IPG is used by ST Jude medical together with an 88 lamitrode lead
test different settings of stimulation
| Study group | Role | What they receive |
|---|---|---|
| Tonic | Experimental | 5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA) Receives: Procedure: dorsal column stimulator |
| Sham | Experimental | no stimulation, patient receive a sham stimulation (actually the IPG is not running) Receives: Procedure: dorsal column stimulator |
| burst | Experimental | 500 hz burst at 5 hz stimulation Receives: Procedure: dorsal column stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
Secondary outcomes (1)
VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionSep 2011
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 Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Vanneste, University Hospital, Antwerp
- Investigators
- Sven Vanneste, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486108
- Sponsor's protocol ID
- burst spinal cord stimulation
- Status last verified
- Dec 2011
- First submitted
- 21 Sep 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- 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 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
- ClinicalTrials.gov ID
- NCT01486108
- Acronym / sponsor ID
- burst spinal cord stimulation
- Conditions
- Neuropathic Pain
- Keywords
- tonic, burst and placebo stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Dec 2011 (estimated)
- 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.
Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.
Detailed description
Patients receive three type of stimulation (burst, tonic and sham). We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tonic | Experimental | Procedure: dorsal column stimulator5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA) |
| Sham | Experimental | Procedure: dorsal column stimulatorno stimulation, patient receive a sham stimulation (actually the IPG is not running) |
| burst | Experimental | Procedure: dorsal column stimulator500 hz burst at 5 hz stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients enrolled in this study must meet the following inclusion criteria:
- Patients able to provide informed consent to participate in the study;
- Patient is between the age of 18 and 75;
- Patient has Failed Back Surgery Syndrome;
- Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
Key exclusion criteria (8 listed)
- A patient will be excluded from participation in this study if they meet any one of the following criteria:
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
- Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
- Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- Patient currently participating in another clinical study;
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 |
|---|---|---|
| dorsal column stimulatorAlso: IPG is used by ST Jude medical together with an 88 lamitrode leadtest different settings of stimulation | Procedure or surgery | Sham, Tonic, burst |
Primary outcome
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
1 secondary outcome
VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- 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.
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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.
Sven Vanneste, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dorsal column stimulator in people with Neuropathic Pain, run by University Hospital, Antwerp at 1 site in Belgium.
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 8 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: finished, as of the sponsor's last update on 6 Dec 2011. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia. 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 NCT01486108, 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 6 Dec 2011.