Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

NCT ID: NCT03756012

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-10-02

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.

Conditions

Back Pain; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Low Pulse Width (<500 μsec)

Spinal Cord Stimulation System will be programmed to pulse widths \<500 μsec.

Group Type: ACTIVE_COMPARATOR

Algovita Spinal Cord Stimulation System

Intervention Type: DEVICE

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.

High Pulse Width (>1000 μsec)

Spinal Cord Stimulation System will be programmed to pulse widths \>1000 μsec

Group Type: ACTIVE_COMPARATOR

Algovita Spinal Cord Stimulation System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio Pain Clinic

OTHER

Sponsor Role: collaborator

Kettering Health Network

OTHER

Sponsor Role: lead

Responsible Party

Amol Soin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio Pain Clinic

Centerville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Expanded Long Pulse

Identifier Type: -

Identifier Source: org_study_id