Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

NCT03756012 | Completed Results FDA Device

• 1 other identifier: Expanded Long Pulse
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Targeted Pain

  For 7 days following intervention

• Distribution of Paesthesia

  For 7 days following intervention

• Research Participant Program Preference

  For 7 days following intervention

• Quality of Pain Relief

  For 7 days following intervention

• Research Participant Pain Relief Satisfaction

  For 7 days following intervention

Study Arms (2)

Low Pulse Width (<500 μsec)

ACTIVE COMPARATOR

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

Device: Algovita Spinal Cord Stimulation System

High Pulse Width (>1000 μsec)

ACTIVE COMPARATOR

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

Device: Algovita Spinal Cord Stimulation System

Interventions

Algovita Spinal Cord Stimulation System 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); Low Pulse Width (<500 μsec)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kettering Health Network: lead
• Ohio Pain Clinic: collaborator

Study Sites (1)

The Ohio Pain Clinic

Centerville, Ohio, 45458, United States

Location

MeSH Terms

Conditions

Back Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amol Soin
• Organization: Ohio Pain Clinic

drsoin@ohiopainclinic.com

937-434-2226

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 27, 2018
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)