BurstDR Spinal Cord Stimulation Versus Sham in Established Responders
ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUmeå University
About this trial
This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.
Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.
The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.
Eligibility criteria
Qualifiers
Be 18 years of age or older.
Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.
Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings.
Have had no major change in pain medication for at least 4 weeks before entering the study.
Disqualifiers
An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.
A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.
A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information.
Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.
Trial design
Treatments tested in this trial
- BurstDR Spinal Cord Stimulation
- Sham Spinal Cord Stimulation
Treatment groups
28 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov