Clinical trial NCT04159753: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal cord stimulator (SCS)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
measure: Pain quality, intensity and localization
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
measure: Pain perception
timeFrame: 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 outcomes:
measure: Depression
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
measure: Functioning
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
measure: Participant self-evaluation of Quality of Life
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
measure: Participant's impression of Quality of Life
timeFrame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael Osborne, MD
role: PRINCIPAL_INVESTIGATOR
References: