Clinical trial NCT03718325: Burst Spinal Cord Stimulation (Burst-SCS) Study
Official title: Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Failed Back Surgery Syndrome
Keywords: Burst-SCS
Chronic pain
Spinal cord stimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) score
timeFrame: Pre-implant visit, up to approximately 2 weeks
Secondary outcomes:
measure: Change in Short-Form McGill Pain Questionnaire (SFMPQ) score
timeFrame: Pre-implant visit, up to approximately 2 weeks
measure: Change in General Pain Disability Index (PDI) score
timeFrame: Pre-implant visit, up to approximately 2 weeks
measure: Change in Brief Pain Inventory-Short Form (BPI-SF) score
timeFrame: Pre-implant visit, up to approximately 2 weeks
measure: Michigan Body Map (MBM)
timeFrame: up to approximately 2 weeks
measure: Fibromyalgia Survey Questionnaire (FSQ)
timeFrame: up to approximately 2 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Scott Lempka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.