Chronic Pain
Conditions
Keywords
Spinal Cord Stimulation, Chronic Pain
Brief summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
Interventions
DEVICESpinal Cord Stimulation
Patients eligible for SCS
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | 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. |
Countries
Belgium
Participant flow
Recruitment details
3 subjects were enrolled. However 2 were implanted and proceeded to crossover phase
Participants by arm
| Arm | Count |
|---|---|
| Subjects Received 4 Interventions (4 Programs) Four Programs utilized included DC perception and sub-perception; DR perception and subperception based programming | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Subjects Received 4 Interventions (4 Programs) |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 1 / 2 | 1 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 1 | 1 / 2 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dorsal Column (DC) Perception | Change in Pain Intensity | 5 units on a scale |
| Dorsal Root (DR) Perception | Change in Pain Intensity | 4.5 units on a scale |
| Dorsal Root (DR) Sub-perception | Change in Pain Intensity | 4.5 units on a scale |
| Dorsal Column (DC) Sub-perception | Change in Pain Intensity | 1 units on a scale |