Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulator

Detailed Description

The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

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:

• Males and females ≥18 years-old
• Diagnosed with chronic pain
• Have an already-implanted Eon Family IPG for a minimum period of 6 months
• Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
• Signed informed consent

Exclusion Criteria:

• Subject's overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
• Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
• Subject has an infusion pump or any other implantable neurostimulator device
• Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
• Subject's pain originates from peripheral vascular disease
• Subject is immunocompromised
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
• Subject has history of cancer requiring active treatment in the last 6 months
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Spinal Cord Stimulator; Burst neurostimulation	Device: Spinal Cord Stimulator; We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).; Other Names: Neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change in Pain scores using Numeric Rating Scale (1-10)	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Pain quality, intensity and localization	Change in pain perception using Short-Form McGill Pain Questionnaire-2	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Pain perception	Change in pain perception using the Pain Catastrophizing Scale self-reported survey	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Change in depression scores using Beck Depression Inventory-II self reported survey	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Functioning	Change in patient's functioning using Oswestry Disability Index self-reported survey	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Participant self-evaluation of Quality of Life	Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Participant's impression of Quality of Life	Change in quality of life using Patient Global Impression of Change self-reported survey on activity limitations, symptoms and emotions	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Osborne, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): April 14, 2021
• Study Completion (ACTUAL): April 14, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Spinal cord stimulator (SCS)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 19-001362

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: No
• product manufactured in and exported from the U.S.: Yes