Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on clinical outcomes during a temporary SCS trial.

Detailed Description
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The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. 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 Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days. The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three 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.

Official Title
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Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial

Conditions
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Spinal Cord Stimulation, Pain, Back, Pain

Intervention / Treatment
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* Device: Algovita Spinal Cord Stimulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement Study candidate is undergoing a SCS trial using Nuvectra Algostim system Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. Subject is 18 years of age or older when written informed consent is obtained Exclusion Criteria: Subject is contraindicated for an Algovita SCS system Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments Subject has a life expectancy of less than 2 years Subject is participating in another clinical study that would confound data analysis Subject has a coexisting pain condition that might confound pain ratings Subject has a significant psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: <500 µS Pulse Width<br>Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief. | Device: Algovita Spinal Cord Stimulation System<br>* The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.<br>|
| Experimental: >1000 µS Pulse Width<br>Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief. | Device: Algovita Spinal Cord Stimulation System<br>* The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Pain Relief | The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours. | up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Paresthesia | 1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. | Up to 8 days | 
| Subject Preference | Subjects will be asked to select their favorite program | Up to 8 days | 
| Quality of Pain Relief | Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor | Up to 8 days | 
| Subject Satisfaction | Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied | Up to 8 days | 
| Achievement of ≥50% Pain Relief | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. | Up to 8 days | 
| Rate of AEs | Rate of device-related and/or procedure-related AEs | From spinal cord stimulation implant through study completion or study exit, Up to 8 days |