Chronic Low Back PainSGX-SCS-RCTNCT03606187
Stimgenics Open-Label, Post Market Study
A study testing Stimgenics SCS Programming Approach and Standard SCS Programming Approach in people with Chronic Low Back Pain, run by Stimgenics LLC at 1 site in United States.
Trial summary
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Stimgenics SCS Programming Approach and Standard SCS Programming Approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 22 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
- Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
- Be 18 years of age or older at the time of enrollment
- Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- Be willing to not increase pain medications from baseline through the 3-Month Visit
- Be willing and able to comply with study-related requirements, procedures, and visits
Who cannot join
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
- Has mechanical spine instability as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.
Read the detailed description
This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
- Test treatment group with SGX-SCS programming approach
- Control treatment group with Standard SCS programming approach
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
- Conditions
- Chronic Low Back Pain
- Being tested
- Stimgenics SCS Programming Approach, Standard SCS Programming Approach
- Keywords
- Back Pain, Spinal Cord Stimulation
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimgenics SCS Programming ApproachDevice
Stimgenics SCS Programming approach Using Intellis(TM) SCS system
Standard SCS Programming ApproachDevice
Standard SCS Programming approach using Intellis(TM) SCS system
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Subjects randomized to this arm will receive test treatment Receives: Device: Stimgenics SCS Programming Approach |
| Control Arm | Active comparator | Subjects randomized to this arm will receive control treatment Receives: Device: Standard SCS Programming Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Individual Responders
Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).
Measured: 3 months
Secondary outcomes (5)
Percentage of Individual Responders
The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority
Measured: 3 months
Change in Back Pain Score
Comparison of change from Baseline in back pain score (using Visual Analog Scale 0.0-10.0cm) determined at the 3- and 6-month visit after device activation, between test and control in a statistical test of non-inferiority. This is calculated as: Change from Baseline in Back Pain VAS = 3-Month Visit Pain VAS - Baseline Pain VAS.
Measured: 3 months
6 Months Comparison of Back Pain Treatment Success
Comparison of Back Pain Treatment Success (responder rate), measured as subjects with at least a 50% reduction in Back Pain Visual Analog Scale (VAS), evaluated at 6 months after device activation, between test and control
Measured: 6 months
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) evaluated at 3 months visit
Measured: 3 months
Adverse Events
Frequency of treatment emergent adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start26 Jun 2018
- Primary completion8 Nov 2019
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimgenics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606187
- Sponsor's protocol ID
- SGEN-2018PM2
- Acronym
- SGX-SCS-RCT
- Status last verified
- Feb 2021
- First submitted
- 12 Jul 2018
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain
- ClinicalTrials.gov ID
- NCT03606187
- Acronym / sponsor ID
- SGX-SCS-RCT / SGEN-2018PM2
- Conditions
- Chronic Low Back Pain
- Keywords
- Back Pain, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Stimgenics LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 2 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.
Detailed description
This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
- Test treatment group with SGX-SCS programming approach
- Control treatment group with Standard SCS programming approach
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Device: Stimgenics SCS Programming ApproachSubjects randomized to this arm will receive test treatment |
| Control Arm | Active comparator | Device: Standard SCS Programming ApproachSubjects randomized to this arm will receive control treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
- Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
- Be 18 years of age or older at the time of enrollment
Key exclusion criteria (5 listed)
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
- Has mechanical spine instability as determined by the Investigator
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 |
|---|---|---|
| Stimgenics SCS Programming ApproachStimgenics SCS Programming approach Using Intellis(TM) SCS system | Device | Test Arm |
| Standard SCS Programming ApproachStandard SCS Programming approach using Intellis(TM) SCS system | Device | Control Arm |
Primary outcome
The Percentage of Individual Responders
Time frame: 3 months
Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).
5 secondary outcomes
Percentage of Individual Responders
Time frame: 3 months
Change in Back Pain Score
Time frame: 3 months
6 Months Comparison of Back Pain Treatment Success
Time frame: 6 months
Oswestry Disability Index (ODI)
Time frame: 3 months
Adverse Events
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Low Back Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimgenics SCS Programming Approach and Standard SCS Programming Approach in people with Chronic Low Back Pain, run by Stimgenics LLC at 1 site in United States.
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 8 inclusion and 5 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Individual Responders (time frame: 3 months). 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 2 Mar 2021.