N/A
N=2
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04073446 ↗Enrolled (actual)
2
Serious AEs
14.3%
Results posted
Mar 2023
Primary outcome: Primary: Change in Pain Intensity — 5; 4.5; 4.5; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinal Cord Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
5; 4.5; 4.5; 1 | — |
Summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04073446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.