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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Spinal cord stimulator (SCS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 8, 2019
Last Updated
January 3, 2022
Sponsor
Mayo Clinic
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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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