NCT02902796

Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief

Randomized Controlled Cross Over Study to Compare the Efficacy of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Axial Pain Relief

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Center for Clinical Research, Winston-Salem, NC · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study will enroll 22 patients for the purpose of evaluation of efficacy of burst stimulation, 1000 hertz frequency stimulation or standard stimulation in patients who have a spinal cord stimulators implanted. Each patients will be randomized to either group A or B, where each groups consists of Burst, standard, and 1000 hertz frequency stimulation or vice versa with wash off period in between. The duration for each stimulation modes will be approximately 3 weeks, with approximately 4 days of wash off prior to starting the new stimulation mode and in between stimulation modes. Treatment duration for each groups will last about 3 months or less, and with cross over total duration of the study is about 6 months in total. During the trial there will be 13 visits. The first visit will consist of screening visit activities and once the eligibility of the subjects are confirmed, they will be randomized and they can start the study immediately and begin their wash off period. After the initial visit/ randomization visit, there will be 12 follow up visits. At each visit, patients will be assessed for their pain, disability index, and their perception of their painful condition, as well as any adverse events and changes of medication usage or lack there of. At the end of the study, the data will be pooled to look at the pain level, disability index, and patients perceived changes in their painful condition for each treatment groups (Burst stimulation, 1000 hertz stimulation and standard stimulation) to determine if subject experienced equivocal pain relief from all three stimulation modes.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-09-16
• Last updated: 2019-01-31

Locations

1 site across 1 country: United States