Chronic PainFOCALNCT04073446
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
A study testing Spinal Cord Stimulation in people with Chronic Pain, run by Boston Scientific Corporation at 1 site in Belgium.
Trial summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief. 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?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Oct 2019to 1 Oct 2021
- 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
- Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
- Subject signed a valid, EC-approved informed consent form (ICF)
- Willing and able to comply with all protocol-required procedures and assessments/evaluations
- 18 years of age or older when written informed consent is obtained
Who cannot join
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
- Conditions
- Chronic Pain
- Being tested
- Spinal Cord Stimulation
- Keywords
- Spinal Cord Stimulation, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Patients eligible for SCS
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Column (DC) Perception | Active comparator | Use of DC Perception based programming Receives: Device: Spinal Cord Stimulation |
| Dorsal Root (DR) Perception | Active comparator | Use of DR Perception based programming Receives: Device: Spinal Cord Stimulation |
| Dorsal Root (DR) Sub-perception | Active comparator | Use of DR sub-perception based programming Receives: Device: Spinal Cord Stimulation |
| Dorsal Column (DC) Sub-perception | Active comparator | Use of DC sub-perception based programming Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Change in pain intensity from Baseline to end of each Period (knee/foot).
Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start31 Oct 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 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 Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073446
- Sponsor's protocol ID
- A4068
- Acronym
- FOCAL
- Status last verified
- Dec 2022
- First submitted
- 23 Jul 2019
- Last updated
- 29 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
- ClinicalTrials.gov ID
- NCT04073446
- Acronym / sponsor ID
- FOCAL / A4068
- Conditions
- Chronic Pain
- Keywords
- Spinal Cord Stimulation, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dorsal Column (DC) Perception | Active comparator | Device: Spinal Cord StimulationUse of DC Perception based programming |
| Dorsal Root (DR) Perception | Active comparator | Device: Spinal Cord StimulationUse of DR Perception based programming |
| Dorsal Root (DR) Sub-perception | Active comparator | Device: Spinal Cord StimulationUse of DR sub-perception based programming |
| Dorsal Column (DC) Sub-perception | Active comparator | Device: Spinal Cord StimulationUse of DC sub-perception based programming |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
- Subject signed a valid, EC-approved informed consent form (ICF)
- Willing and able to comply with all protocol-required procedures and assessments/evaluations
- 18 years of age or older when written informed consent is obtained
Key exclusion criteria (2 listed)
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this 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 |
|---|---|---|
| Spinal Cord StimulationPatients eligible for SCS | Device | Dorsal Column (DC) Perception, Dorsal Column (DC) Sub-perception, Dorsal Root (DR) Perception, Dorsal Root (DR) Sub-perception |
Primary outcome
Change in Pain Intensity
Time frame: up to 6 weeks
Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Corporation
1 site 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 in people with Chronic Pain, run by Boston Scientific Corporation 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 4 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2023). 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?
Change in Pain Intensity (time frame: up to 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 29 Mar 2023.