N/A
Completed N=40
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
Postoperative Pain · Back Pain
Source: ClinicalTrials.gov NCT03251937 ↗
Enrolled (actual)
40
Serious AEs
7.2%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline — 31 Participants
Summary
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline |
31 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic pain of the trunk and/or limbs
- 22 years of age or older at time of enrollment
- Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English
- Willing and capable of giving informed consent
Key Exclusion Criteria
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Current systemic infection, or local infection in close proximity to the anticipated surgical field
- Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception
- Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Data sourced from ClinicalTrials.gov (NCT03251937). 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.