Burst Spinal Cord Stimulation (Burst-SCS) Study

NCT03718325 | Terminated Results FDA Device

• 2 other identifiers: HUM00147961UL1TR002240
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Failed Back Surgery Syndrome

Keywords

Burst-SCS; Chronic pain; Spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) Score

  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.

  Up to one month following the pre-implant visit.

Secondary Outcomes (6)

• 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.

Study Arms (2)

Burst-SCS/sham SCS

OTHER

First, participants will receive Burst-SCS. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.

Device: Burst-SCS; Device: Sham SCS

Sham SCS/Burst-SCS

OTHER

First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive Burst-SCS. Study evaluations will be completed prior to and after stimulation.

Device: Burst-SCS; Device: Sham SCS

Interventions

Burst-SCS DEVICE

The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.

Burst-SCS/sham SCS; Sham SCS/Burst-SCS

Sham SCS DEVICE

The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.

Burst-SCS/sham SCS; Sham SCS/Burst-SCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Chronic Pain; Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain

Results Point of Contact

• Title: Dr. Scott Lempka
• Organization: University of Michigan

NeuromodulationLab@med.umich.edu

734-647-9052

Study Officials

• Scott Lempka, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering and Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: March 12, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)