Chronic PainNCT01665040
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
A study testing Neurostimulation device implantation in people with Chronic Pain, run by Boston Scientific Corporation at 7 sites in 3 countries.
Trial summary
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs. 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?
- Neurostimulation device implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2012to Dec 2014
- 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
- Chronic intractable pain of the trunk and/or limbs
- Documented history of trunk and/or limb pain of at least 180 days
- Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
- Subject is willing and able to comply with all protocol-required follow-up evaluations
- 18 years of age or older when written informed consent is obtained
- Subject signs informed consent
Who cannot join
- Unable to operate the Precision Spectra™ System either by self or with a caregiver
- Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
- Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- Is a high surgical risk
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period
- Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG
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- Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
- Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator
- Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial.
- Failed to achieve satisfactory relief during the stimulation trial phase
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Spain4 sites
Clinica Universitaria de Navarra
Madrid
Hospital La Paz
Madrid
Hospital Universitario Quiron Madrid
Madrid
H. Clinico Universitario
Valencia
Australia2 sites
Metro Spinal Clinic
Caulfield
Hunter Clinical Research
Melbourne
About this study
Official title: Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
- Conditions
- Chronic Pain
- Being tested
- Neurostimulation device implantation
- Keywords
- neurostimulation, spinal cord stimulation, peripheral nerve stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation device implantationDevice
Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.
Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation for chronic pain | Experimental | Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Receives: Device: Neurostimulation device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Measured: 90-days post permanent implantation
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Measured: 365 days post permanent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionDec 2014
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 Boston Scientific CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665040
- Sponsor's protocol ID
- A5004
- Status last verified
- Nov 2020
- First submitted
- 9 Aug 2012
- Last updated
- 19 Nov 2020
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
- ClinicalTrials.gov ID
- NCT01665040
- Acronym / sponsor ID
- A5004
- Conditions
- Chronic Pain
- Keywords
- neurostimulation, spinal cord stimulation, peripheral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation for chronic pain | Experimental | Device: Neurostimulation device implantationNeurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic intractable pain of the trunk and/or limbs
- Documented history of trunk and/or limb pain of at least 180 days
- Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
- Subject is willing and able to comply with all protocol-required follow-up evaluations
Key exclusion criteria (10 listed)
- Unable to operate the Precision Spectra™ System either by self or with a caregiver
- Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
- Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
- Is a high surgical risk
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period
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 |
|---|---|---|
| Neurostimulation device implantationStudy subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan. | Device | Neurostimulation for chronic pain |
Primary outcome
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Time frame: 90-days post permanent implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Time frame: 365 days post permanent implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- 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.
Roshini Jain study director
Boston Scientific Neuromodulation Corporation
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation device implantation in people with Chronic Pain, run by Boston Scientific Corporation at 7 sites in 3 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 7 inclusion and 10 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Australia, 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 3 Jan 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?
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation (time frame: 90-days post permanent implantation). The study lists 2 primary outcomes in all. 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 19 Nov 2020.