A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover… (NCT04693650) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain
Taiwan22 participantsStarted 2021-03-01
Plain-language summary
This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Age ≥ 20
✓. Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
✓. Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
✓. Subject is willing and able to comply with the procedure and requirements of this trial.
✓. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.
Exclusion criteria
✕. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
✕. has the mental or psychological condition that affects pain perception or
✕. has difficulty performing objective pain assessment or lack of suitability for participation in the study.
. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
✕. Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT \< 100,000/μl or INR \> 1.4 at screening visit.
✕. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
✕. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
✕. Subject has a current diagnosis of cancer with active symptoms.