Neck PainSENZA-ULNNCT02385201
Clinical Trial of the Senza™ SCS System in the Treatment of Chronic Upper Limb and Neck Pain
A study testing Senza in people with Neck Pain and Chronic Pain, run by Nevro Corp at 1 site in United States.
Trial summary
This is a prospective, multi-center feasibility study of effectiveness and safety of the Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. 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
- Neck Pain, Chronic 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 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 the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain
- Considering daily activity and rest, have average upper limb and/or neck pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study 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 willing and capable of giving informed consent
Show all 9Show fewer
- Be willing and able to comply with study-related requirements, procedures, and visits
- 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 adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
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, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
- Have a current diagnosis of a progressive neurological disease as determined by the Investigator
- Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- Have a condition that the Investigator determines would significantly increase perioperative risk
- Significant cervical stenosis
Show all 17Show fewer
- Any previous history of surgery on the posterior elements (laminectomy, posterior fusion)
- Be benefitting within from an interventional procedure and/or surgery to treat upper limb pain (Subjects should be enrolled at least 30 days from last benefit)
- Have an existing drug pump and/or another active implantable device such as a pacemaker
- Have a condition currently requiring or likely to require the use of MRI or diathermy
- Have metastatic malignant disease or active local malignant disease
- Have a life expectancy of less than 1 year
- Have an active systemic or local infection
- 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 or have been a substance abuser (including alcohol and illicit drugs)
- Be concomitantly participating in another clinical study
- Be involved in an injury claim under current litigation -
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 Upper Limb and Neck Pain
This is a prospective, multi-center feasibility study of effectiveness and safety of the Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
Read the detailed description
Study subjects will be identified from the pool of candidates for SCS therapy affiliated with, or referred to, the clinical sites. Subjects will participate in this investigational plan that includes entry criteria evaluation, Baseline assessments, trial stimulation phase, and post-trial assessment. Subjects with a successful Trial Phase will receive a permanent implant of an Implantable Pulse Generator (IPG) and leads, and undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation.
Subjects who sign the informed consent will undergo evaluations to determine eligibility for the study based on the inclusion and exclusion criteria. Baseline assessments will also include measures for pain, disability, functioning, medication use, quality of life, depression and sleep.
Implantation and use of the Senza System will follow the Nevro Physician's Manual and supporting Manuals. Subjects will undergo a Trial Phase lasting up to 14 days to determine his/her response to SCS therapy. Following the Trial Phase with external device stimulation, subjects will be assessed for their pain, and those who have a successful Trial Phase will be eligible to proceed to permanent implantation of a SCS system.
Following permanent device implant, the IPG will be "activated" and thus, stimulation delivered on an ongoing basis for 12 months. At 1 month and 9 months following Post-Permanent Device Activation, assessments of pain and adverse events will be made. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse events as well as disability, functioning, medication use, quality of life, depression and sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Senza
- Medical subject headings
- Neck Pain, Chronic Pain
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 | Subjects with chronic, intractable pain of the upper limbs and/or neck will be implanted with a Senza Spinal Cord Stimulation (SCS) system designed to deliver electrical stimulation to the spinal cord. Receives: Device: Senza |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who respond to Senza SCS therapy (as assessed by VAS) for upper limb or neck pain
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 posted11 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brad Gliner, Study director, Nevro Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385201
- Sponsor's protocol ID
- CA2014 US
- Acronym
- SENZA-ULN
- Status last verified
- Oct 2018
- First submitted
- 3 Mar 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 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 Upper Limb and Neck Pain
- ClinicalTrials.gov ID
- NCT02385201
- Acronym / sponsor ID
- SENZA-ULN / CA2014 US
- Conditions
- Neck Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Mar 2015 (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 feasibility study of effectiveness and safety of the Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
Detailed description
Study subjects will be identified from the pool of candidates for SCS therapy affiliated with, or referred to, the clinical sites. Subjects will participate in this investigational plan that includes entry criteria evaluation, Baseline assessments, trial stimulation phase, and post-trial assessment. Subjects with a successful Trial Phase will receive a permanent implant of an Implantable Pulse Generator (IPG) and leads, and undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation.
Subjects who sign the informed consent will undergo evaluations to determine eligibility for the study based on the inclusion and exclusion criteria. Baseline assessments will also include measures for pain, disability, functioning, medication use, quality of life, depression and sleep.
Implantation and use of the Senza System will follow the Nevro Physician's Manual and supporting Manuals. Subjects will undergo a Trial Phase lasting up to 14 days to determine his/her response to SCS therapy. Following the Trial Phase with external device stimulation, subjects will be assessed for their pain, and those who have a successful Trial Phase will be eligible to proceed to permanent implantation of a SCS system.
Following permanent device implant, the IPG will be "activated" and thus, stimulation delivered on an ongoing basis for 12 months. At 1 month and 9 months following Post-Permanent Device Activation, assessments of pain and adverse events will be made. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse events as well as disability, functioning, medication use, quality of life, depression and sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.
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: SenzaSubjects with chronic, intractable pain of the upper limbs and/or neck will be implanted with a Senza Spinal Cord Stimulation (SCS) system designed to deliver electrical stimulation to the spinal cord. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain
- Considering daily activity and rest, have average upper limb and/or neck pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study 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
Key exclusion criteria (17 listed)
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
- Have a current diagnosis of a progressive neurological disease as determined by the Investigator
- Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- Have a condition that the Investigator determines would significantly increase perioperative risk
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
The proportion of subjects who respond to Senza SCS therapy (as assessed by VAS) for upper limb or neck pain
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 9 Oct 2018.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial 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.
Brad Gliner 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 Neck Pain and Chronic 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 9 inclusion and 17 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 9 Oct 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?
The proportion of subjects who respond to Senza SCS therapy (as assessed by VAS) for upper limb or neck pain (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 9 Oct 2018.