Clinical trial NCT03680846: Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Lead sponsor: Nevro Corp
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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

Primary outcomes:
measure: Difference between treatment groups in responder rates.
timeFrame: 3 Months
Secondary outcomes:
measure: Change in Disability as Measured by Oswestry Disability Index
timeFrame: 6 months
measure: Percentage change from baseline in back pain intensity (as assessed by VAS)
timeFrame: 6 months
measure: Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
timeFrame: 6 months
measure: Global impression of change
timeFrame: 6 months
measure: Change from baseline in opioid equivalent medication usage in each group
timeFrame: 6 months
measure: Neurological assessment
timeFrame: 3, 6 and 12 months
measure: Incidences of adverse events
timeFrame: 3, 6 and 12 months
Other outcomes:
measure: Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)
timeFrame: 24 months
measure: Observational Outcomes on disability using Oswestry Disability Index scores
timeFrame: 24 months
measure: Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire
timeFrame: 24 months
Locations:
city: Redwood City
country: United States
facility: Nevro Corp
state: California
Study officials:
affiliation: Nevro Corp
name: David Caraway, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.