Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Back Pain
• Intervention / Treatment: Device: Algovita Spinal Cord Stimulation System

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Centerville, Ohio, United States, 45458
      • The Ohio Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Pulse Width (<500 μsec); Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec.	Device: Algovita Spinal Cord Stimulation System; 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.
Active Comparator: High Pulse Width (>1000 μsec); Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec	Device: Algovita Spinal Cord Stimulation System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Pulse Widths on Pain Clinical Outcomes	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.	For 7 days following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Targeted Pain	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.	For 7 days following intervention
Distribution of Paesthesia	At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.	For 7 days following intervention
Research Participant Program Preference	At the end of the trial period, subjects will be asked to select their favorite program.	For 7 days following intervention
Quality of Pain Relief	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	For 7 days following intervention
Research Participant Pain Relief Satisfaction	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	For 7 days following intervention
≥ 50% Pain Relief	Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)	For 7 days following intervention
Rate of AEs	Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.	For 7 days following intervention

Collaborators and Investigators

• Sponsor: Kettering Health Network
• Collaborators: Ohio Pain Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): October 2, 2019
• Study Completion (Actual): October 2, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: Expanded Long Pulse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No