Chronic Neuropathic Pain in the Low Back and LegsNCT02916498
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
A study testing Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System in people with Chronic Neuropathic Pain in the Low Back and Legs, run by Boston Scientific Corporation at 2 sites in United Kingdom.
Trial summary
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neuropathic Pain in the Low Back and Legs
- What is being tested?
- Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Feb 2017to 23 Jul 2018
- 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
- Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
- Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
- Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)
Who cannot join
- Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
- Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St. Bartholomew's Hospital
London, EC1A 7Be
James Cook University Hospital
Middlesbrough, TS4 3BW
About this study
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
- Being tested
- Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
- Keywords
- chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemDevice
Spinal cord stimulation for the management of chronic neuropathic pain
| Study group | Role | What they receive |
|---|---|---|
| Bipolar then alternative field shape stimulation | Active comparator | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days Receives: Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System |
| Alternative then bipolar field shape stimulation | Experimental | Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days Receives: Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preferred Field Shape
Number of participants preferring bipolar field shape and alternative field shape
Measured: 42 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start7 Feb 2017
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Why it stopped: Stopped due to a business decision
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 Neuropathic Pain in the Low Back and LegsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Eldabe, MD, Principal investigator, James Cook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916498
- Sponsor's protocol ID
- A4062
- Status last verified
- Jan 2021
- First submitted
- 22 Sep 2016
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
- ClinicalTrials.gov ID
- NCT02916498
- Acronym / sponsor ID
- A4062
- Keywords
- chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to a business decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar then alternative field shape stimulation | Active comparator | Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemBoston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days |
| Alternative then bipolar field shape stimulation | Experimental | Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemBoston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
- Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
- Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)
Key exclusion criteria (2 listed)
- Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
- Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
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 |
|---|---|---|
| Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemSpinal cord stimulation for the management of chronic neuropathic pain | Device | Alternative then bipolar field shape stimulation, Bipolar then alternative field shape stimulation |
Primary outcome
Patient Preferred Field Shape
Time frame: 42 days post randomization
Number of participants preferring bipolar field shape and alternative field shape
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Sam Eldabe, MD principal investigator
James Cook University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System in people with Chronic Neuropathic Pain in the Low Back and Legs, run by Boston Scientific Corporation at 2 sites in United Kingdom.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 2 Oct 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?
Patient Preferred Field Shape (time frame: 42 days post randomization). 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 29 Jan 2021.