Upper Extremity PainUEPNCT02703818
SCS for the Treatment Of Chronic Pain of the Upper Extremities
A study testing Senza in people with Upper Extremity Pain, run by Nevro Corp at 1 site in United States.
Trial summary
This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Pain
- What is being tested?
- Senza
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
- Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
- Be 18 years of age or older at the time of enrollment.
- Be an appropriate candidate for the surgical procedures required in this study.
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
- Have stable neurological status measured by motor, sensory and reflex function.
Who cannot join
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
- Have a current diagnosis of a progressive neurological disease.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- Have mechanical spine instability as determined.
- Have significant stenosis, based on MRI.
- Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
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- Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
- Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- Be involved in an injury claim under current litigation.
- Have a pending or approved worker's compensation claim.
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment Of Chronic Pain of the Upper Extremities
This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
- Conditions
- Upper Extremity Pain
- Being tested
- Senza
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenzaDevice
Spinal Cord Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Senza | Experimental | Spinal Cord Stimulation for UEP Receives: Device: Senza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
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 posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Caraway, MD, Study director, Nevro Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703818
- Sponsor's protocol ID
- CA2015-4 US
- Acronym
- UEP
- Status last verified
- Nov 2018
- First submitted
- 2 Mar 2016
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Burgher A, Kosek P, Surrett S, Rosen SM, Bromberg T, Gulve A, Kansal A, Wu P, McRoberts WP, Udeshi A, Esposito M, Gliner BE, Maneshi M, Rotte A, Subbaroyan J. Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study. J Pain Res. 2020 Nov 10;13:2837-2851. doi: 10.2147/JPR.S278661. eCollection 2020.
PubMed 33204145
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment Of Chronic Pain of the Upper Extremities
- ClinicalTrials.gov ID
- NCT02703818
- Acronym / sponsor ID
- UEP / CA2015-4 US
- Conditions
- Upper Extremity Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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 is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senza | Experimental | Device: SenzaSpinal Cord Stimulation for UEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
- Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
- Be 18 years of age or older at the time of enrollment.
- Be an appropriate candidate for the surgical procedures required in this study.
Key exclusion criteria (12 listed)
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
- Have a current diagnosis of a progressive neurological disease.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- Have mechanical spine instability as determined.
- Have significant stenosis, based on MRI.
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 |
|---|---|---|
| SenzaSpinal Cord Stimulation | Device | Senza |
Primary outcome
Responder Rate
Time frame: 3 months
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 3 Dec 2018.
- Derived from this study: PubMed 33204145Burgher A, Kosek P, Surrett S, Rosen SM, Bromberg T, Gulve A, Kansal A, Wu P, McRoberts WP, Udeshi A, Esposito M, Gliner BE, Maneshi M, Rotte A, Subbaroyan J. Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study. J Pain Res. 2020 Nov 10;13:2837-2851. doi: 10.2147/JPR.S278661. eCollection 2020.
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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.
David Caraway, MD study director
Nevro Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senza in people with Upper Extremity Pain, run by Nevro Corp 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 7 inclusion and 12 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 3 Dec 2018. 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?
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?
Responder Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703818, which also lists 1 linked publication.
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 3 Dec 2018.