Burst Spinal Cord Stimulation (Burst-SCS) Study

University of Michigan

Status: Terminated

Conditions: Pain, Chronic; Failed Back Surgery Syndrome

Treatments: Device: Burst-SCS; Device: Sham SCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03718325

UL1TR002240 (U.S. NIH Grant/Contract)

HUM00147961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Burst-SCS/sham SCS

Other group

Description:

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.

Treatment:

Device: Sham SCS

Device: Burst-SCS

Sham SCS/Burst-SCS

Other group

Description:

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.

Treatment:

Device: Sham SCS

Device: Burst-SCS