N/A
N=99
Combining Mechanisms for Better Outcomes (COMBO)
Chronic Pain · Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03689920 ↗Enrolled (actual)
99
Serious AEs
10.1%
Results posted
Nov 2020
Primary outcome: Primary: Overall Pain Responder Rate — 36; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Pain Responder Rate |
36; 34 | — |
Summary
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Eligibility Criteria
Key Inclusion Criteria
- Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- 22 years of age or older at time of enrollment
- Able to independently read and complete all questionnaires and assessments provided in English
- Signed a valid, IRB-approved informed consent form (ICF) provided in English
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
- Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- 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 (NCT03689920). 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.