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

Chronic Pain Clinical Trial

Official title:

An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04159753
• Other study ID #: 19-001362
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: April 14, 2021

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 14, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Change in Pain scores using Numeric Rating Scale (1-10)	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Primary	Pain quality, intensity and localization	Change in pain perception using Short-Form McGill Pain Questionnaire-2	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Primary	Pain perception	Change in pain perception using the Pain Catastrophizing Scale self-reported survey	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	Depression	Change in depression scores using Beck Depression Inventory-II self reported survey	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	Functioning	Change in patient's functioning using Oswestry Disability Index self-reported survey	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	Participant self-evaluation of Quality of Life	Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey	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	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	Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends

External Links

•   Mayo Clinic Clinical Trials