Status:
COMPLETED
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
Lead Sponsor:
Kettering Health Network
Collaborating Sponsors:
Ohio Pain Clinic
Conditions:
Back Pain
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of pulse widths \<500 μsec and \>1000 μsec on clinical outcomes during a temporary SCS trial.
Detailed Description
The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjec...
Eligibility Criteria
Inclusion
- be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
- be undergoing a SCS trial using Algovita® SCS system
- sign a valid, Institutional Review Board (IRB)-approved informed consent form.
- be 18 years of age or older when written informed consent is obtained
Exclusion
- be contraindicated for an Algovita® SCS system
- have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
- have a life expectancy of less than 2 years
- be participating in another clinical study that would confound data analysis
- have a coexisting pain condition that might confound pain ratings
- have a significant psychiatric disorder
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03756012
Start Date
November 27 2018
End Date
October 2 2019
Last Update
March 8 2021
Active Locations (1)
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1
The Ohio Pain Clinic
Centerville, Ohio, United States, 45458