Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change in Visual Analog Scale (VAS) Score
Study Overview
Brief Summary
Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.
Detailed Description
The study was terminated early following the identification of data quality concerns and protocol integrity issues, specifically related to inadequate sham stimulation parameters and compromised participant blinding. Results reporting was significantly delayed due to research-related pauses during the COVID-19 pandemic. Although there were initial plans to resume enrollment and study procedures once feasible, a comprehensive review of the study data identified the protocol integrity concerns, leading to the decision to terminate the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
There will be two research teams. One team will be unblinded (e.g. clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g. research personnel) and will perform clinical testing and collect study outcome measures.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome and intractable low back and leg pain, and for whom Burst-SCS has been recommended as a treatment option
- •Candidates who can speak, read, and understand English
Exclusion Criteria
- •Subjects who are pregnant- as determined by verbal report or chart review
- •Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principal investigator
- •Subjects who are unable or unwilling to cooperate with clinical testing
- •Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol
Outcomes
Primary Outcomes
Change in Visual Analog Scale (VAS) Score
Time Frame: Up to one month following the pre-implant visit.
Visual analog scale (VAS) was a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" printed below. The participant marked on the line the point that they felt represented their perception of their current state. The score was determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters, with a score between 0 (no pain) to a score of 100 (worst possible pain). Higher VAS values represented more severe pain and lower values represented lower pain. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain) and positive values indicate worsening (increased pain). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Secondary Outcomes
- Change in Short-Form McGill Pain Questionnaire (SFMPQ) Score(Up to one month following the pre-implant visit.)
- Change in General Pain Disability Index (PDI) Score(Up to one month following the pre-implant visit.)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Score(Up to one month following the pre-implant visit.)
- Michigan Body Map (MBM)(Up to one month following the pre-implant visit.)
- Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index(Up to one month following the pre-implant visit.)
- Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index(Up to one month following the pre-implant visit.)
Investigators
Scott Lempka
Associate Professor of Biomedical Engineering and Associate Professor of Anesthesiology
University of Michigan