Burst Optimized Stimulation Study
CompletedNot applicableNCT02896361
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Study details
- Official title
- Burst Optimized Stimulation Study
- Conditions
- Interventions
- Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
- Sponsor
- Abbott Medical Devices
- Collaborators
- Medizinische Einrichtungen der Universität Düsseldorf; Klinikum Duisburg GmbH; NKO Sint-Augustinus Antwerpen
- Start date
- 2016-07
- Primary completion
- 2017-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Belgium, Germany
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain; * Subject has been exclusively using burst stimulation for at least three months; * Subject is 18 years of age or older; * Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation; * Subject agrees not to add or increase pain-related medication from enrollment through the study duration; * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; Exclusion Criteria: * Subject is currently participating in a clinical investigation study that includes an active treatment arm; * Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation; * Subject has a non SJM neuromodulation device
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02896361