Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000153617
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
10/02/2014
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Date results information initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multi-Center, Prospective Clinical Trial of the Senza Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain
Scientific title
Multi-Center, Single-Arm, Prospective Clinical Trial of the Senza Spinal Cord Stimulation (SCS) System in the Treatment of Subjects with Chronic Pain Associated with the Upper Limb and Neck
Secondary ID [1] 283997 0
Nil
Universal Trial Number (UTN)
Trial acronym
SENZA-Upper Limb and Neck
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Upper Limb and/or Neck Pain 291035 0
Condition category
Condition code
Anaesthesiology 291374 291374 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal Cord Stimulation
Subjects will undergo implantation of leads in the epidural space of the spinal column. Electrical stimulation will be applied constantly via an external trial stimulator (TSM) for approximately 7 days to determine if stimulation is helpful in the relief of pain of the upper limbs and/or neck. If the patient and physician feel the stimulation is effective (standard pain assessment tools will be used), the patient will undergo permanent implantation of leads and implantable pulse generator (IPG). The device can be reprogrammed by personnel at the physician's office to optimize therapy. During reprogramming, usage statistics are available to the physician.

Permanent implant surgery:
As with other SCS procedures, a Touhy needle is inserted into the back at a location determined by the physician and the lead is passed through the needle into the spinal space. Once the lead tip is located in the area the physician deems appropriate (based on location of the patient's pain), the lead is anchored and sutured in place. The other end of the lead is then tunneled under the skin to the area of the body the physician deems appropriate for IPG placement. A pocket is created at that location to accommodate the IPG. The leads are connected to the IPG and all incisions are sutured. All system components are implanted. This procedure lasts 30-90 minutes.

Temporary trial:
For the trial phase, a Touhy needle is inserted into the back at a location determined by the physician and the lead is passed through the needle into the spinal space untilthe lead tip is located in the area the physician deems appropriate (based on location of the patient's pain). When the trial is temporary, the leads are not anchored down. The other end of the lead is externalized and connected to the trial stimulator for the duration of the trial. Appropriate steps are taken to ensure sterility. This procedure lasts 30-60 minutes.
Intervention code [1] 288687 0
Treatment: Devices
Intervention code [2] 288731 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291367 0
Response to SCS therapy as assessed by VAS without stimulation-related neurological deficit at the Primary Effectiveness Assessment
Timepoint [1] 291367 0
3 months
Secondary outcome [1] 306612 0
Response to SCS therapy as assessed by VAS without stimulation-related neurological deficit at the Primary Effectiveness Assessment (50% or greater reduction in pain from Baseline)
Timepoint [1] 306612 0
3 months
Secondary outcome [2] 306613 0
Change from Baseline in disability as measured by Pain Disability Index (PDI) at the Primary Effectiveness Assessment
Timepoint [2] 306613 0
3, 6, 12 months
Secondary outcome [3] 306692 0
Adverse events will be collected for subjects at all visits
Timepoint [3] 306692 0
12 months
Secondary outcome [4] 306693 0
Change from Baseline in Short Form McGill Pain Questionnaire (SFMPQ2)
Timepoint [4] 306693 0
3, 6, 12 months
Secondary outcome [5] 306694 0
Change from Baseline in quality of life as measured by SF-12
Timepoint [5] 306694 0
3, 6, 12 months
Secondary outcome [6] 306695 0
Change from Baseline in depression as measured by Beck Depression
Inventory II
Timepoint [6] 306695 0
3, 6, 12 months
Secondary outcome [7] 306696 0
Change from Baseline in sleep disturbance as measured by Pittsburgh
Sleep Quality Index
Timepoint [7] 306696 0
3, 6, 12 months
Secondary outcome [8] 306697 0
Change from Baseline in opioid medication usage
Timepoint [8] 306697 0
3, 6, 12 months
Secondary outcome [9] 306698 0
Subject's impression of change in quality of life as measured by the
Patient Global Impression of Change instrument
Timepoint [9] 306698 0
3, 12 months
Secondary outcome [10] 306699 0
Investigator’s impression of change in subject quality of life as measured by the Clinician Global Impression of Change instrument
Timepoint [10] 306699 0
3, 12 months

Eligibility
Key inclusion criteria
1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain.

2. Considering daily activity and rest, have average upper limb or neck pain intensity of greater than or equal to 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.

3. Be an appropriate candidate for HF10 SCS.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study assessments , accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and
fibromyalgia).

2. 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.

3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe cervical spinal stenosis and brachial plexus injury as determined by the investigator.

4. Having pain in the shoulder girdle or arm with a primary etiology due to a shoulder pathology.

5. Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus.

6. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention. Neurologic pathology related to severe or critical cervical spondylosis including spinal stenosis (AP diameter <10 mm), myelomalacia not related to a previously corrected stenosis, radiculopathy manifest clinically by motor deficit in setting of anatomic etiology (herniated nucleus pulposis).

7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment of subjects will occur at the clinical sites only after Ethics Committee (EC) approvals, and written informed consent from subjects have been obtained. Subjects that have been determined to be candidates for HF10 SCS therapy will be approached by Investigators/clinical site staff about potential participation in the study. Following consent, subjects will be selected to participate in the study based upon inclusion and exclusion criteria defined in this investigational plan. Inclusion and exclusion criteria will be assessed based on pain assessments, radiographic studies, pregnancy test (if needed), stability of pain and medication, subject medical records and history, assessment tools, subject interviews, and the Investigator’s clinical judgment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2014
Actual
13/02/2014
Date of last participant enrolment
Anticipated
Actual
13/12/2016
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
75
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 288624 0
Commercial sector/Industry
Name [1] 288624 0
Nevro Corp
Country [1] 288624 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nevro Corp
Address
1800 Bridge Parkway
Redwood City
CA 94065
USA
Country
United States of America
Secondary sponsor category [1] 287331 0
None
Name [1] 287331 0
Address [1] 287331 0
Country [1] 287331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290482 0
Bellberry HREC
Ethics committee address [1] 290482 0
129 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 290482 0
Australia
Date submitted for ethics approval [1] 290482 0
Approval date [1] 290482 0
16/12/2013
Ethics approval number [1] 290482 0
IRB00005845

Summary
Brief summary
This is a multi-center, prospective, study to collect data on the commercially available Nevro Senza SCS System. Outcomes will be assessed via standardized assessments (trial and IPG implant procedures are part of routine practice). The purpose of this study is to document and assess safety and effectiveness of HF10 electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the upper limb and neck, as part of the centers’ routine practice (on-label use of TGA approved/CE marked device).

Data at follow-up visits will be compared to Baseline data collected at the beginning of the study. This study includes extensive data collection (Trial and IPG implant procedures are part of routine practice).

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 be implanted a permanent system (i.e. IPG) and leads as per center’s routine practice, and undergo 12 months of stimulation delivery with assessments
at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation.

Assessments of pain and adverse events will be made at 1 month and 9 months following Post-Permanent Device Activation. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse
events as well as disability, functioning, neurological assessment, 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45890 0
Dr Marc Russo
Address 45890 0
Hunter Clinical Research,
220 Denison Street,
Broadmeadow,
Newcastle, NSW 2292
Country 45890 0
Australia
Phone 45890 0
+61 2 4985 1800
Fax 45890 0
Email 45890 0
[email protected]
Contact person for public queries
Name 45891 0
Mr Wim Laloo
Address 45891 0
Nevro Corp
1800 Bridge Parkway
Redwood City
CA 94065
USA
Country 45891 0
United States of America
Phone 45891 0
+32 476 596978
Fax 45891 0
Email 45891 0
[email protected]
Contact person for scientific queries
Name 45892 0
Mrs Adele Barnard
Address 45892 0
Nevro Corp
1800 Bridge Parkway
Redwood City
CA 94065
USA
Country 45892 0
United States of America
Phone 45892 0
+61 402110625
Fax 45892 0
Email 45892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not as per sponsor's practice


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo North American Neuromodulation Society 22nd Annual... [More Details] 365708-(Uploaded-30-03-2019-05-07-35)-Other results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAbstracts from the North American Neuromodulation Society's 2021 Virtual Meeting, January 15-16, 2021.2021https://dx.doi.org/10.1111/ner.13385
Embase10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.2020https://dx.doi.org/10.1007/s00586-020-06480-x
N.B. These documents automatically identified may not have been verified by the study sponsor.