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

Not Applicable

Terminated

• Conditions: Chronic Pain

• Registration Number: NCT04159753
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Primary Completion: 2021-04-14
• Study Completion: 2021-04-14
• Status Verified: 2021-11
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States