Chronic PainNCT04693650
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
A study testing NeuroBlock UHF stimulation in people with Chronic Pain and Low Back Pain, run by GiMer Medical at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Pain, Low Back Pain, Lower Limb Pain
- What is being tested?
- NeuroBlock UHF stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Mar 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subject has a known terminal illness with life expectancy less than one year.
- Subject has a systematic or local infection, which may increase study risk.
- Subject currently has an indwelling device that may pose an increased risk of infection.
- Subject is pregnant or breast feeding.
- Subject has a medical history of drug or alcohol addiction within the past 2 years.
- Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
- Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
- Subject is a prisoner.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
China Medical University Hospital
Taichung
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Veterans General Hospital-Taipei
Taipei
About this study
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.
- Conditions
- Chronic Pain, Low Back Pain, Lower Limb Pain
- Being tested
- NeuroBlock UHF stimulation
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroBlock UHF stimulationDevice
Also called +RF (plus RF, pulsed RF)
NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse
| Study group | Role | What they receive |
|---|---|---|
| Treatment group- UHF(+RF) stimulation | Experimental | Patients implanted with leads and be administered with UHF stimulation Receives: Device: NeuroBlock UHF stimulation |
| Control group | No intervention | Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Responder Rate
The responder rate of the test group and control group at the 2-week visit
Measured: 2 weeks
Safety: AEs and SAEs
Incidence of adverse events (AEs) and serious AEs (SAEs)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Mar 2021
- Primary completion1 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GiMer Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693650
- Sponsor's protocol ID
- P20002
- Status last verified
- Feb 2023
- First submitted
- 31 Dec 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04693650
- Acronym / sponsor ID
- P20002
- Conditions
- Chronic Pain, Low Back Pain, Lower Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GiMer MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group- UHF(+RF) stimulation | Experimental | Device: NeuroBlock UHF stimulationPatients implanted with leads and be administered with UHF stimulation |
| Control group | No intervention | –Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroBlock UHF stimulationAlso: +RF (plus RF, pulsed RF)NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse | Device | Treatment group- UHF(+RF) stimulation |
Primary outcome
Effectiveness: Responder Rate
Time frame: 2 weeks
The responder rate of the test group and control group at the 2-week visit
Safety: AEs and SAEs
Time frame: 4 weeks
Incidence of adverse events (AEs) and serious AEs (SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroBlock UHF stimulation in people with Chronic Pain and Low Back Pain, run by GiMer Medical at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Responder Rate (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.