Clinical trial NCT04693650: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Low Back Pain
Lower Limb Pain
Lead sponsor: GiMer Medical
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20
2. 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.
3. 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).
4. Subject is willing and able to comply with the procedure and requirements of this trial.
5. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion Criteria:

1. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:

   1. has the mental or psychological condition that affects pain perception or
   2. has difficulty performing objective pain assessment or lack of suitability for participation in the study.
2. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
3. 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.
4. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
5. 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.
6. Subject has a current diagnosis of cancer with active symptoms.
7. Subject has a known terminal illness with life expectancy less than one year.
8. Subject has a systematic or local infection, which may increase study risk.
9. Subject currently has an indwelling device that may pose an increased risk of infection.
10. Subject is pregnant or breast feeding.
11. Subject has a medical history of drug or alcohol addiction within the past 2 years.
12. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
13. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
14. Subject is a prisoner.

Primary outcomes:
measure: Effectiveness: Responder Rate
timeFrame: 2 weeks
measure: Safety: AEs and SAEs
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital-Taipei
Study officials:
References: