Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief
NCT02902796 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-01-31
Summary
A randomized controlled with cross over study compares efficacy of burst stimulation, 1000 hertz stimulation, and standard stimulation in an non-superiority trial. The study duration is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with approximately 4 days of wash off in between.
Conditions
Interventions
- DEVICE
-
Spinal cord stimulator
Spinal cord stimulator will be programmed to deliver, according to the randomization status of the patient, burst, 1000 hertz, and standard stimulation during each treatment group.
Sponsors & Collaborators
-
The Center for Clinical Research, Winston-Salem, NC
lead OTHER
Principal Investigators
-
James North, MD · The Center for Clinical Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2019-09-30
- Completion
- 2019-12-31
Countries
- United States
Study Locations
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