Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

Not Applicable

• Conditions: Back Pain
• Interventions: Device: HF10 Therapy; Other: CMM

• Registration Number: NCT03680846
• Lead Sponsor: Nevro Corp

Brief 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. This study is a multi-center, prospective, randomized study to compare the two treatment groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2018-09-05
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Primary Completion: 2020-10-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-12
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. 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

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. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
5. Have any addictions as determined by the Investigator
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have prior experience with neuromodulation devices
8. Other general exclusions applicable for SCS devices
9. Be involved in an injury claim under current litigation
10. Have a pending or approved worker's compensation claim

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HF10 + CMM	HF10 Therapy	Addition of HF10 therapy to CMM
CMM	CMM	Conventional Medical Management
HF10 + CMM	CMM	Addition of HF10 therapy to CMM

Primary Outcome Measures

Name	Time	Method
Difference between treatment groups in responder rates.	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 Outcome Measures

Name	Time	Method
Percentage change from baseline in back pain intensity (as assessed by VAS)	6 months
Change from baseline in opioid equivalent medication usage in each group	6 months
Global impression of change	6 months	Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire
Change in Disability as Measured by Oswestry Disability Index	6 months	Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score
Neurological assessment	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.
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire	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".
Incidences of adverse events	3, 6 and 12 months

Trial Locations

Locations (1)

Nevro Corp; 🇺🇸 Redwood City, California, United States