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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159753
Recruitment Status : Enrolling by invitation
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Michael D. Osborne, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Spinal Cord Stimulator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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 Name: Neurostimulator




Primary Outcome Measures :
  1. Pain intensity [ 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 ]
    Change in Pain scores using Numeric Rating Scale (1-10)

  2. Pain quality, intensity and localization [ 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 ]
    Change in pain perception using Short-Form McGill Pain Questionnaire-2

  3. Pain perception [ 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 ]
    Change in pain perception using the Pain Catastrophizing Scale self-reported survey


Secondary Outcome Measures :
  1. Depression [ 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 ]
    Change in depression scores using Beck Depression Inventory-II self reported survey

  2. Functioning [ 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 ]
    Change in patient's functioning using Oswestry Disability Index self-reported survey

  3. Participant self-evaluation of Quality of Life [ 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 ]
    Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey

  4. Participant's impression of Quality of Life [ 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 ]
    Change in quality of life using Patient Global Impression of Change self-reported survey on activity limitations, symptoms and emotions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159753


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Osborne, MD Mayo Clinic
Additional Information:
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Responsible Party: Michael D. Osborne, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04159753    
Other Study ID Numbers: 19-001362
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michael D. Osborne, Mayo Clinic:
Spinal cord stimulator (SCS)
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms