N/A
Completed N=140
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Source: ClinicalTrials.gov NCT02314000 ↗Enrolled (actual)
140
Serious AEs
3.3%
Results posted
Apr 2019
Primary outcomePrimary: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline — 32; 41 Participants
Summary
To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline |
32; 41 | — |
Eligibility Criteria
Key Inclusion Criteria
- Complaint of chronic pain of the trunk and/or limbs
- Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
- Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English
Key Exclusion Criteria
- Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Data sourced from ClinicalTrials.gov (NCT02314000). 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. Informational only — not medical advice.