Trialing of ISS in Patients With CRPS (NCT03954080) | Clinical Trial Compass
CompletedNot Applicable
Trialing of ISS in Patients With CRPS
United States16 participantsStarted 2019-06-13
Plain-language summary
This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study. A standard of care trial phase to test a subjects' response to Intraspinal-Optimal Stim therapy will be conducted during a 3 to 10-day period. Patients that obtain 50% or greater pain relief during the trial period will undergo permanent implantation of the device. Primary outcome will evaluate pain response at 3 months of therapy, based on NPRS pain score relative to baseline. Patients will be followed up for 6 months after the start of therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of giving written informed consent to participate in this clinical study.
✓. Must be 18 years old or older.
✓. Predominant pain in one or both of the lower limbs attributed to CRPS or causalgia that has been refractory to conservative therapy for at least 3 months.
✓. Average pain intensity larger or equal to 6 on the numeric pain rating scale (NPRS).
✓. Appropriate candidate for spinal cord stimulation as determined by the Investigator.
✓. Subjects must be on a stable dose of pain medication regimen for at least 1 month.
✓. Must be able to comply with the requirements of study visits.
✓. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.
Exclusion criteria
✕. Systemic infection.
✕
What they're measuring
1
Change in pain relative to baseline pain (i.e. prior to therapy) at 3 months after device activation for providing Intraspinal-Optimal Stim therapy
✕. Evidence of serious neurological, psychological or psychiatric disorders.
✕. Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s).
✕. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
✕. Human immunodeficiency virus (HIV) infection or a clinically significant infection.
✕. A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
✕. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.