Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Not Applicable

Completed

Conditions: Back Pain
Pain

Interventions: Device: Algovita Spinal Cord Stimulation System

Registration Number: NCT03756012

Lead Sponsor: Kettering Health Network

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 subjects in the study per site. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Pulse Width (<500 μsec)	Algovita Spinal Cord Stimulation System	Spinal Cord Stimulation System will be programmed to pulse widths \<500 μsec.
High Pulse Width (>1000 μsec)	Algovita Spinal Cord Stimulation System	Spinal Cord Stimulation System will be programmed to pulse widths \>1000 μsec

Primary Outcome Measures

Name	Time	Method
Effect of Pulse Widths on Pain Clinical Outcomes	For 7 days following intervention	To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.

Secondary Outcome Measures

Name	Time	Method
Change in Targeted Pain	For 7 days following intervention	To evaluate the effect of conventional pulse widths \<500μsecand pulse widths and \>1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.
Rate of AEs	For 7 days following intervention	Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
Distribution of Paesthesia	For 7 days following intervention	At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Research Participant Program Preference	For 7 days following intervention	At the end of the trial period, subjects will be asked to select their favorite program.
Research Participant Pain Relief Satisfaction	For 7 days following intervention	At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Quality of Pain Relief	For 7 days following intervention	At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor
≥ 50% Pain Relief	For 7 days following intervention	Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)