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Completed

NCT Number: NCT03680846

Comparison of HF10 Therapy Combined With CMM to CMM Alone 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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nevro Corp

Redwood City, California, 94065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  • 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

Treatment and study plan

HF10 Therapy

Device

Senza 10 kHz Spinal Cord Stimulation

CMM

Other

Conventional Medical Management

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in Disability as Measured by Oswestry Disability Index

    Time frame: 6 months

    Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score

  2. Percentage change from baseline in back pain intensity (as assessed by VAS)

    Time frame: 6 months

  3. Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire

    Time frame: 6 months

    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".

  4. Global impression of change

    Time frame: 6 months

    Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire

  5. Change from baseline in opioid equivalent medication usage in each group

    Time frame: 6 months

  6. Neurological assessment

    Time frame: 3, 6 and 12 months

    Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status.

  7. Incidences of adverse events

    Time frame: 3, 6 and 12 months

Other outcomes

  1. Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)

    Time frame: 24 months

    Percentage change in back pain

  2. Observational Outcomes on disability using Oswestry Disability Index scores

    Time frame: 24 months

    Percentage change from Baseline in ODI score

  3. Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire

    Time frame: 24 months

    Change in quality of life index compared to baseline

Sponsors and collaborators

Lead sponsor

Nevro Corp

Industry

Registry information

Official study 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: NSRBP

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Sep 21, 2018
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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