An interventional study of Spinal Cord Stimulation in Chronic Pain, sponsored by Boston Scientific Corporation. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Use of DC Perception based programming
Device: Spinal Cord Stimulation
Use of DR Perception based programming
Device: Spinal Cord Stimulation
Use of DR sub-perception based programming
Device: Spinal Cord Stimulation
Use of DC sub-perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS
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.
Time frame: up to 6 weeks
3 subjects were enrolled. However 2 were implanted and proceeded to crossover phase
| Milestone | Subjects Received All Interventions (4 Programs) |
|---|---|
| Started | 2 |
| Dc perception | 2 |
| Dr perception | 2 |
| Dr subperception | 2 |
| Dc subperception | 1 |
| Completed | 1 |
| Not completed | 1 |
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.
| units on a scale | Dorsal Column (DC) Perception | Dorsal Root (DR) Perception | Dorsal Root (DR) Sub-perception | Dorsal Column (DC) Sub-perception |
|---|---|---|---|---|
| Change in Pain Intensity | 5 (4 to 6) | 4.5 (2 to 7) | 4.5 (2 to 7) | 1 (1 to 1) |
Collected over Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dorsal Column (DC) Perception | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Dorsal Root (DR) Perception | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Dorsal Column (DC) Sub-perception | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Dorsal Root (DR) Sub-perception | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Event | Dorsal Column (DC) Perception | Dorsal Root (DR) Perception | Dorsal Column (DC) Sub-perception | Dorsal Root (DR) Sub-perception |
|---|---|---|---|---|
| Shoulder PainMusculoskeletal and connective tissue disorders | 0/2 | 0/2 | 0/1 | 1/2 |
| Event | Dorsal Column (DC) Perception | Dorsal Root (DR) Perception | Dorsal Column (DC) Sub-perception | Dorsal Root (DR) Sub-perception |
|---|---|---|---|---|
| FasciculationMusculoskeletal and connective tissue disorders | 0/2 | 0/2 | 1/1 | 0/2 |
| No bowel movementsGastrointestinal disorders | 0/2 | 1/2 | 0/1 | 0/2 |
| Age, Continuous(years) | Subjects Received 4 Interventions (4 Programs) |
|---|---|
| Mean | 59 (47 to 71) |
| Sex: Female, Male(Participants) | Subjects Received 4 Interventions (4 Programs) |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Subjects Received 4 Interventions (4 Programs) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston Scientific Corporation