ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Response to SCS therapy as assessed by VAS without stimulation-related neurological deficit at the Primary Effectiveness Assessment

Timepoint [1]

3 months

Secondary outcome [1]

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]

3 months

Secondary outcome [2]

Change from Baseline in disability as measured by Pain Disability Index (PDI) at the Primary Effectiveness Assessment

Timepoint [2]

3, 6, 12 months

Secondary outcome [3]

Adverse events will be collected for subjects at all visits

Timepoint [3]

12 months

Secondary outcome [4]

Change from Baseline in Short Form McGill Pain Questionnaire (SFMPQ2)

Timepoint [4]

3, 6, 12 months

Secondary outcome [5]

Change from Baseline in quality of life as measured by SF-12

Timepoint [5]

3, 6, 12 months

Secondary outcome [6]

Change from Baseline in depression as measured by Beck Depression
Inventory II

Timepoint [6]

3, 6, 12 months

Secondary outcome [7]

Change from Baseline in sleep disturbance as measured by Pittsburgh
Sleep Quality Index

Timepoint [7]

3, 6, 12 months

Secondary outcome [8]

Change from Baseline in opioid medication usage

Timepoint [8]

3, 6, 12 months

Secondary outcome [9]

Subject's impression of change in quality of life as measured by the
Patient Global Impression of Change instrument

Timepoint [9]

3, 12 months

Secondary outcome [10]

Investigator’s impression of change in subject quality of life as measured by the Clinician Global Impression of Change instrument

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Nevro Corp

Address [1]

1800 Bridge Parkway
Redwood City
CA 94065
USA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry HREC

Ethics committee address [1]

129 Glen Osmond Road
Eastwood SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/12/2013

Ethics approval number [1]

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

Dr Marc Russo

Address

Hunter Clinical Research,
220 Denison Street,
Broadmeadow,
Newcastle, NSW 2292

Country

Australia

Phone

+61 2 4985 1800

Fax

pi@hunterclinicalresearch.com.au

Contact person for public queries

Name

Wim Laloo

Address

Nevro Corp
1800 Bridge Parkway
Redwood City
CA 94065
USA

Country

United States of America

Phone

+32 476 596978

Fax

laloo@nevro.com

Contact person for scientific queries

Name

Adele Barnard

Address

Nevro Corp
1800 Bridge Parkway
Redwood City
CA 94065
USA

Country

United States of America

Phone

+61 402110625

Fax

adele.barnard@nevro.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.	2020	https://dx.doi.org/10.1007/s00586-020-06480-x
Embase	Abstracts from the North American Neuromodulation Society's 2021 Virtual Meeting, January 15-16, 2021.	2021	https://dx.doi.org/10.1111/ner.13385

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically