Back PainNSRBPNCT03680846
Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
A study testing HF10 Therapy and CMM in people with Back Pain, run by Nevro Corp at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- HF10 Therapy and CMM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 9 May 2022
- 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, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
- Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
- Qualifying pain score
- Be on stable pain medications, as determined by the Investigator
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and visits
- 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
Who cannot join
- Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
- Have a medical condition or pain in other area(s), not intended to be treated in this study
- Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
- Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
- Have any addictions as determined by the Investigator
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
Show all 10Show fewer
- Have prior experience with neuromodulation devices
- Other general exclusions applicable for SCS devices
- Be involved in an injury claim under current litigation
- Have a pending or approved worker's compensation claim
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
- Conditions
- Back Pain
- Being tested
- HF10 Therapy, CMM
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF10 TherapyDevice
Senza 10 kHz Spinal Cord Stimulation
CMMOther
Conventional Medical Management
| Study group | Role | What they receive |
|---|---|---|
| CMM | Other | Conventional Medical Management Receives: Other: CMM |
| HF10 + CMM | Active comparator | Addition of HF10 therapy to CMM Receives: Device: HF10 Therapy; Other: CMM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment groups in responder rates.
Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS)
Measured: 3 Months
Secondary outcomes (7)
Change in Disability as Measured by Oswestry Disability Index
Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score
Measured: 6 months
Percentage change from baseline in back pain intensity (as assessed by VAS)
Measured: 6 months
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
It measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. In addition there is an EQ VAS which records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value".
Measured: 6 months
Global impression of change
Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire
Measured: 6 months
Change from baseline in opioid equivalent medication usage in each group
Measured: 6 months
Neurological assessment
Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status.
Measured: 3, 6 and 12 months
Incidences of adverse events
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start5 Sep 2018
- Primary completion6 Oct 2020
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 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
- NCT03680846
- Sponsor's protocol ID
- CA2018-2 US NSRBP
- Acronym
- NSRBP
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2017
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473Patel N, Calodney A, Kapural L, Province-Azalde R, Lad SP, Pilitsis J, Wu C, Cherry T, Subbaroyan J, Gliner B, Caraway D. High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial. Pain Pract. 2021 Feb;21(2):171-183. doi: 10.1111/papr.12945. Epub 2020 Sep 26.
PubMed 33463027
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03680846
- Acronym / sponsor ID
- NSRBP / CA2018-2 US NSRBP
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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 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. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMM | Other | Other: CMMConventional Medical Management |
| HF10 + CMM | Active comparator | Device: HF10 Therapy, Other: CMMAddition of HF10 therapy to CMM |
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, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
- Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
- Qualifying pain score
- Be on stable pain medications, as determined by the Investigator
- Be willing and capable of giving informed consent
Key exclusion criteria (10 listed)
- Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
- Have a medical condition or pain in other area(s), not intended to be treated in this study
- Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
- Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
- Have any addictions as determined by the Investigator
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 |
|---|---|---|
| HF10 TherapySenza 10 kHz Spinal Cord Stimulation | Device | HF10 + CMM |
| CMMConventional Medical Management | Other | CMM, HF10 + CMM |
Primary outcome
Difference between treatment groups in responder rates.
Time frame: 3 Months
Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS)
7 secondary outcomes
Change in Disability as Measured by Oswestry Disability Index
Time frame: 6 months
Percentage change from baseline in back pain intensity (as assessed by VAS)
Time frame: 6 months
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
Time frame: 6 months
Global impression of change
Time frame: 6 months
Change from baseline in opioid equivalent medication usage in each group
Time frame: 6 months
Neurological assessment
Time frame: 3, 6 and 12 months
Incidences of adverse events
Time frame: 3, 6 and 12 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 26 Jun 2026.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Derived from this study: PubMed 33463027Patel N, Calodney A, Kapural L, Province-Azalde R, Lad SP, Pilitsis J, Wu C, Cherry T, Subbaroyan J, Gliner B, Caraway D. High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial. Pain Pract. 2021 Feb;21(2):171-183. doi: 10.1111/papr.12945. Epub 2020 Sep 26.
Related trials for Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back 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.
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 HF10 Therapy and CMM in people with Back 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 10 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 26 Jun 2026. 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?
Difference between treatment groups in responder rates. (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 NCT03680846, which also lists 2 linked publications.
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 26 Jun 2026.