Chronic PainNCT03110601
Study of PM Modulation Therapy in Trial Phase
A study testing Test - Stimgenics SCS in people with Chronic Pain, run by Stimgenics LLC at 1 site in United States.
Trial summary
Trialing of PM modulation therapy in patients with chronic intractable low back pain Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Test - Stimgenics SCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 12 Oct 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
- Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
- Must be older than 18 years old.
- Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
- Appropriate candidate for spinal cord stimulation trial.
- Subjects must be on a stable dose of pain medication regimen for at least 1 month.
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- Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff.
- Must be able to comply with the requirement of study visits and follow-up and phone visits.
- Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.
Who cannot join
- Systemic infection.
- Any active implanted device.
- Previous experience with SCS therapy either during a trial or fully implanted
- Evidence of serious neurological, psychological or psychiatric disorders.
- Mechanical spinal instability.
- Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
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- Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
- Human immunodeficiency virus (HIV) infection or a clinically significant infection.
- Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation.
- A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
- Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
- Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
- Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
- Medical condition or pain in other body areas that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
- Concurrent participation in another clinical study.
- Involvement in an injury claim under current litigation or a pending or approved workers' compensation claim.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain
Trialing of PM modulation therapy in patients with chronic intractable low back pain
- Conditions
- Chronic Pain
- Being tested
- Control - Conventional SCS, Test - Stimgenics SCS
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - Conventional SCSDevice
Conventional SCS Parameters
Test - Stimgenics SCSDevice
Stimgenics SCS Parameters
| Study group | Role | What they receive |
|---|---|---|
| Control - Conventional SCS | Active comparator | Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. Receives: Device: Control - Conventional SCS |
| Washout Period | No intervention | 1 day where no stimulation is provided |
| Test - Stimgenics SCS | Experimental | Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. Receives: Device: Test - Stimgenics SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Relative to Baseline and After a Trial Period
Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
Measured: Baseline and 4 days plus or minus 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start5 May 2017
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT03110601
- Sponsor's protocol ID
- SGEN-2017PM1
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2017
- Last updated
- 16 Apr 2019
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain
- ClinicalTrials.gov ID
- NCT03110601
- Acronym / sponsor ID
- SGEN-2017PM1
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stimgenics LLCIndustry (pharma, biotech, devices)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trialing of PM modulation therapy in patients with chronic intractable low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - Conventional SCS | Active comparator | Device: Control - Conventional SCSConventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. |
| Washout Period | No intervention | –1 day where no stimulation is provided |
| Test - Stimgenics SCS | Experimental | Device: Test - Stimgenics SCSStimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
- Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
- Must be older than 18 years old.
- Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
- Appropriate candidate for spinal cord stimulation trial.
Key exclusion criteria (16 listed)
- Systemic infection.
- Any active implanted device.
- Previous experience with SCS therapy either during a trial or fully implanted
- Evidence of serious neurological, psychological or psychiatric disorders.
- Mechanical spinal instability.
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 |
|---|---|---|
| Control - Conventional SCSConventional SCS Parameters | Device | Control - Conventional SCS |
| Test - Stimgenics SCSStimgenics SCS Parameters | Device | Test - Stimgenics SCS |
Primary outcome
Change in Pain Relative to Baseline and After a Trial Period
Time frame: Baseline and 4 days plus or minus 1 days
Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test - Stimgenics SCS in people with Chronic 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 9 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 16 Apr 2019. 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 16 Apr 2019). 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?
Change in Pain Relative to Baseline and After a Trial Period (time frame: Baseline and 4 days plus or minus 1 days). 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 16 Apr 2019.