At a glance
ClinicalIndex Comparison RecordN/ACompleted· 241 enrolled
Drug / intervention
WaveWriter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries
In Brief
A clinical study evaluating WaveWriter and Conventional Medical Managament for Chronic Pain. Completed, enrolled 241 participants across 23 sites.
Detailed Summary
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartMar 2021
Primary CompletionAug 2022
Study CompletionFeb 2025
TodayJul 2026
First PostedDec 19, 2020
Enrollment StartMar 26, 2021
Primary CompletionAug 25, 2022
Study CompletionFeb 21, 2025
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.5 years ago
Interventions
WaveWriterdevice
To receive Spinal Cord Stimulation programming
Conventional Medical Managamentother
To receive conventional medical management