Chronic PainBOSSNCT02896361
Burst Optimized Stimulation Study
A study testing Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol in people with Chronic Pain, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial summary
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
- Subject has been exclusively using burst stimulation for at least three months;
- Subject is 18 years of age or older;
- Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
- Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
- Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
Who cannot join
- Subject is currently participating in a clinical investigation study that includes an active treatment arm;
- Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
- Subject has a non SJM neuromodulation device
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Klinikum Duisburg GmbH
Duisburg, North Rhine-Westphalia, 47055
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Read the detailed description
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.
Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
- Conditions
- Chronic Pain
- Being tested
- Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolDevice
Stimulation parameters are reprogrammed from original values to study defined ones
| Study group | Role | What they receive |
|---|---|---|
| Stimulation order 1 | Experimental | Stimulations delivered in following order:
1. Standard burst
2. Burst Microdosing 1
3. Burst Microdosing 2 Receives: Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol |
| Stimulation order 2 | Experimental | Stimulations delivered in following order:
1. Burst Microdosing 1
2. Burst Microdosing 2
3. Standard burst Receives: Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol |
| Stimulation order 3 | Experimental | Stimulations delivered in following order:
1. Burst Microdosing 2
2. Standard burst
3. Burst Microdosing 1 Receives: Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Pain
Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Measured: assessed every 2 weeks after each intervention, for a total of 6 weeks
Secondary outcomes (4)
EQ-5D
European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life
Measured: assessed every 2 weeks after each intervention, for a total of 6 weeks
Subject Preference
questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were
- first intervention
- second intervention
- third intervention
- no preference
Measured: assessed 6 weeks after baseline at the last follow up visit
Subject Satisfaction
questionnaire on satisfaction with current therapy
Measured: assessed every 2 weeks after each intervention, for a total of 6 weeks
Percentage of Participants With Adverse Events
Measured: assessed over 6 weeks of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medizinische Einrichtungen der Universität Düsseldorf, Klinikum Duisburg GmbH, NKO Sint-Augustinus Antwerpen
- Responsible party
- Sponsor
- Investigators
- Lalit Venkatesan, Ph.D., Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896361
- Sponsor's protocol ID
- SJM-CIP-10125
- Acronym
- BOSS
- Status last verified
- May 2019
- First submitted
- 1 Sep 2016
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burst Optimized Stimulation Study
- ClinicalTrials.gov ID
- NCT02896361
- Acronym / sponsor ID
- BOSS / SJM-CIP-10125
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Medizinische Einrichtungen der Universität Düsseldorf, Klinikum Duisburg GmbH, NKO Sint-Augustinus Antwerpen
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Detailed description
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.
Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stimulation order 1 | Experimental | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolStimulations delivered in following order: 1. Standard burst 2. Burst Microdosing 1 3. Burst Microdosing 2 |
| Stimulation order 2 | Experimental | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolStimulations delivered in following order: 1. Burst Microdosing 1 2. Burst Microdosing 2 3. Standard burst |
| Stimulation order 3 | Experimental | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolStimulations delivered in following order: 1. Burst Microdosing 2 2. Standard burst 3. Burst Microdosing 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
- Subject has been exclusively using burst stimulation for at least three months;
- Subject is 18 years of age or older;
- Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
- Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
Key exclusion criteria (3 listed)
- Subject is currently participating in a clinical investigation study that includes an active treatment arm;
- Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
- Subject has a non SJM neuromodulation device
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 |
|---|---|---|
| Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolStimulation parameters are reprogrammed from original values to study defined ones | Device | Stimulation order 1, Stimulation order 2, Stimulation order 3 |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
4 secondary outcomes
EQ-5D
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
Subject Preference
Time frame: assessed 6 weeks after baseline at the last follow up visit
Subject Satisfaction
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
Percentage of Participants With Adverse Events
Time frame: assessed over 6 weeks of study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lalit Venkatesan, Ph.D. study director
Abbott Medical Devices
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol in people with Chronic Pain, run by Abbott Medical Devices at 3 sites in 2 countries.
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 6 inclusion and 3 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 30 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 3 sites in Germany, 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?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Analog Scale (VAS) for Pain (time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2019.