Burst spinal cord stimulation for chronic pain relief
Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
This study is testing if a new type of spinal cord stimulation can help people with chronic pain after back surgery feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03718325 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of burst spinal cord stimulation (Burst-SCS) in reducing chronic pain in patients with failed back surgery syndrome. Participants who have been recommended for Burst-SCS therapy will undergo a temporary external trial as part of their standard care. The study includes evaluations at various time points and features a randomized, double-blind, crossover phase to compare the effects of Burst-SCS against sham stimulation. The device used for this intervention is the St. Jude Medical Invisible Trial System.
Who should consider this trial
Good fit: Ideal candidates are men and women with chronic, intractable pain due to failed back surgery syndrome who are eligible for Burst-SCS therapy.
Not a fit: Patients who are pregnant or unable to cooperate with clinical testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic pain.
How similar studies have performed: Other studies have shown promise with spinal cord stimulation approaches, but Burst-SCS represents a novel method that is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Scott Lempka, PhD — University of Michigan
- Study coordinator: Scott Lempka, PhD
- Email: NeuromodulationLab@med.umich.edu
- Phone: (734) 647-9052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.