Burst Spinal Cord Stimulation (Burst-SCS) Study
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | March 12, 2019 |
| End Date: | November 2020 |
| Contact: | Vishwanath Sankarasubramanian, PhD |
| Email: | vishwans@med.umich.edu |
| Phone: | (734) 647-9052 |
Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
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.
(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.
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
- Candidates who are willing to limit the introduction of any new medications or
treatment modalities for control of chronic pain symptoms during the study
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
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