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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

Tracking Information
First Submitted Date  ICMJE November 8, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE October 10, 2019
Estimated Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • 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)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
Official Title  ICMJE An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Pain
Intervention  ICMJE 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
Study Arms  ICMJE Spinal Cord Stimulator
Burst neurostimulation
Intervention: Device: Spinal Cord Stimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2022
Estimated Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159753
Other Study ID Numbers  ICMJE 19-001362
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael D. Osborne, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Osborne, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP