Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulator
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring Spinal cord stimulator (SCS)
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Spinal Cord Stimulator
Arm Description
Burst neurostimulation
Outcomes
Primary Outcome Measures
Pain intensity
Change in Pain scores using Numeric Rating Scale (1-10)
Pain quality, intensity and localization
Change in pain perception using Short-Form McGill Pain Questionnaire-2
Pain perception
Change in pain perception using the Pain Catastrophizing Scale self-reported survey
Secondary Outcome Measures
Depression
Change in depression scores using Beck Depression Inventory-II self reported survey
Functioning
Change in patient's functioning using Oswestry Disability Index self-reported survey
Participant self-evaluation of Quality of Life
Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04159753
Brief Title
Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
Official Title
An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Only 2 patients enrolled
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal cord stimulator (SCS)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulator
Arm Type
Other
Arm Description
Burst neurostimulation
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulator
Other Intervention Name(s)
Neurostimulator
Intervention Description
We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).
Primary Outcome Measure Information:
Title
Pain intensity
Description
Change in Pain scores using Numeric Rating Scale (1-10)
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Title
Pain quality, intensity and localization
Description
Change in pain perception using Short-Form McGill Pain Questionnaire-2
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Title
Pain perception
Description
Change in pain perception using the Pain Catastrophizing Scale self-reported survey
Time Frame
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 Measure Information:
Title
Depression
Description
Change in depression scores using Beck Depression Inventory-II self reported survey
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Title
Functioning
Description
Change in patient's functioning using Oswestry Disability Index self-reported survey
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Title
Participant self-evaluation of Quality of Life
Description
Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Title
Participant's impression of Quality of Life
Description
Change in quality of life using Patient Global Impression of Change self-reported survey on activity limitations, symptoms and emotions
Time Frame
Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Osborne, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
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