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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.