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

NCT03680846 | Unknown FDA Device

• 1 other identifier: CA2018-2 US NSRBP
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  3 Months

Secondary Outcomes (7)

• Change in Disability as Measured by Oswestry Disability Index

  6 months

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

  6 months

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

  6 months

• Global impression of change

  6 months

• Change from baseline in opioid equivalent medication usage in each group

  6 months

Other Outcomes (3)

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

  24 months

• Observational Outcomes on disability using Oswestry Disability Index scores

  24 months

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

  24 months

Study Arms (2)

CMM

OTHER

Conventional Medical Management

Other: CMM

HF10 + CMM

ACTIVE COMPARATOR

Addition of HF10 therapy to CMM

Device: HF10 Therapy; Other: CMM

Interventions

HF10 Therapy DEVICE

Senza 10 kHz Spinal Cord Stimulation

HF10 + CMM

CMM OTHER

Conventional Medical Management

CMM; HF10 + CMM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Be involved in an injury claim under current litigation
• Have a pending or approved worker's compensation claim

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (1)

Nevro Corp

Redwood City, California, 94065, United States

Location

Related Publications (2)

• 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.

  PMID: 34854473 DERIVED

• Patel 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.

  PMID: 33463027 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• David Caraway, MD

  Nevro Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: September 21, 2018
• Study Start: September 5, 2018
• Primary Completion: October 6, 2020
• Study Completion: November 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

US (1)