Trialing of ISS in Patients With CRPS
Completed · Not applicable
Conditions studied: CRPS I, Causalgia
In brief
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.
Key facts
- Study ID
- NCT03954080
- Run by
- Millennium Pain Center
- People needed
- 16
- Starts
- 2019-06-13
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2022-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Systemic infection.
- Any other active implanted device.
- 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.
- Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
- Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
- Medical condition or pain in other body areas determined by the Investigator as interfering with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
- Concurrent participation in another clinical study.
- Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim.
- Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.
Where it is running
- Millennium Pain Center — Bloomington, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.