Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/11/2017
Date assigned
27/11/2017
Last edited
23/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic pain is one of the most common and hard to control medical conditions. Low back pain is a major health problem throughout the world and conventional medical and surgical management is often not sufficient for the treatment of chronic pain. Spinal Cord Stimulation (SCS) has been used to treat low back pain in people with continuous or recurring pain following invasive spinal surgery. There is good evidence to recommend SCS in people with back pain without a history of spinal surgery, particularly because SCS is a less invasive and reversible therapy that may provide greater long-term benefits than more invasive surgical approaches. This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10 Therapy™) delivered through the Senza system in subjects with chronic refractory back pain who are not considered candidates for spine surgery. The subjects will be either allocated to HF10 Therapy or Conventional Medical Managment (CMM). This study aims to further investigate the pain relief achieved when using Nevro's Senza System to treat low back pain in patients who have not undergone invasive spinal surgery compared to the CMM group.

Who can participate?
Adults aged 18 and older who have chronic lower back pain.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive Spinal Cord Stimulation (SCS). Those in the second group receive medical pain management as per the center’s usual practice. SCS involves the surgical placement of two leads (which look like very thin wires) into a small area near the spinal cord. Electrical stimulation is delivered through these wires by a small, battery¬-operated, rechargeable SCS implanted generator. Each participant is followed for 12 months. The participants attend regular clinic visits to complete questionnaires, and to provide feedback on their pain.

What are the possible benefits and risks of participating?
Participants may benefit from both treatments (HF10 therapy and CMM) to relieve their pain. There are no direct risks of taking part in this study, although the general risks of having a spinal stimulation device in place apply.

Where is the study run from?
1. Technical University of Munich (Germany)
2. Guy’s & St. Thomas’s NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
December 2016 to December 2020

Who is funding the study?
Nevro Corp (USA)

Who is the main contact?
Mr Brad Gliner

Trial website

Contact information

Type

Public

Primary contact

Mr Brad Gliner

ORCID ID

Contact details

Nevro Corp
1800 Bridge Parkway
Redwood City
CA94065
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CA2017 SENZA-NSRBP

Study information

Scientific title

A multi-center, prospective, pragmatic, randomized, controlled clinical trial to compare HF10 therapy to Conventional Medical Management in the treatment of Non-Surgical Refractory Back Pain

Acronym

SENZA-NSRBP

Study hypothesis

This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10 Therapy™) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery (i.e., chronic non-surgical refractory back pain).

Ethics approval

North East - York Research EC, 08/08/2017, ref: 224762

Study design

Multi-center prospective randomised study to compare the two treatment groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic non-surgical refractory back pain

Intervention

Participants are randomly allocated in a 1:1 ratio to either the control or the intervention group:

Those in the intervention group receive the HF10 spinal cord stimulation therapy. They undergo Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy). SCS involves the surgical placement of two leads (which look like very thin wires) into a small area near the spinal cord. Electrical stimulation is delivered through these wires by a small, battery-operated, rechargeable SCS implanted generator.

The control group received the Conventional Medical Management (CMM). CMM is the standard treatment provided for chronic back pain patients if not treated with a spinal cord stimulation system – Active Comparator is HF10+CMM. Device is HF10 therapy (Senza 10kHz Spinal Cord Stimulation).

Each participant is followed for 12 months. The participants attend regular clinic visits to complete questionnaires, and to provide feedback on their pain. The treatment for both group is expected to last a total of 12 months.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Responder rates is measured using the visual analog scale (VAS) (as defined by at least a 50% reduction in pain) at 3 months.

Secondary outcome measures

1. Successful back pain relief is measured using the visual analog scale (VAS) at 1, 3, 6, 9 and 12 months
2. Percentage of patients who experience at least 50% reduction in pain intensity is measured using the VAS at 1, 3, 6, 9 and 12 months
3. Back pain intensity is measured using VAS at baseline, 1, 3, 6, 9 and 12 months
4. Percentage of participants who experience a back pain intensity score of ≤2.5 cm as measured using the VAS scale at 1, 3, 6, 9 and 12 months
5. Quality of life is measured using EQ-5D questionnaire at 3, 6 and 12 months
6. Health economic outcomes are measured using clinic visits, incidence of adverse events, EQ-5D at 1, 3, 6, 9 and 12 months

Overall trial start date

05/12/2016

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component
2. Have failed conventional medical treatments
3. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
4. Demonstrating multi-level Degenerative Disc Disease and no current indication for referral for back surgery
5. Considering daily activity and rest, have average back pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
6. Average back pain intensity greater than average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
7. Be on stable pain medications, as determined by the Investigator
8. Be 18 years of age or older at the time of enrollment
9. Be willing and capable of giving informed consent
10. Be willing and able to comply with study-related requirements, procedures, and visits
11. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Have significant clinically mechanical spine instability
5. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
6. Have an opioid addiction or drug seeking behavior as determined by the Investigator
7. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
8. Have prior experience with neuromodulation devices
9. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guideline in the Physician’s Manual
10. Have metastatic malignant disease or active local malignant disease
11. Have a life expectancy of less than 2 years
12. Have an active systemic or local infection
13. Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control)
14. 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)
15. Be concomitantly participating in another clinical study
16. Be involved in an injury claim under current litigation
17. Have a pending or approved worker’s compensation claim

Recruitment start date

31/10/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Austria, Germany, Netherlands, United Kingdom

Trial participating centre

Klinikum rechts der Isar der Technischen Universität München
Munich
81675
Germany

Trial participating centre

Guy’s & St. Thomas’s NHS Foundation Trust
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Nevro Corp

Sponsor details

1800 Bridge Parkway
Redwood City
94065
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Nevro Corp

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The current publication plans for the current study are unknown and will be made available at a later date.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes