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

Back Pain Clinical Trial

— NSRBP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03680846
• Other study ID #: CA2018-2 US NSRBP
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Nevro Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: November 2022
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• HF10 Therapy
Senza 10 kHz Spinal Cord Stimulation

Other:
• CMM
Conventional Medical Management

Locations

Country	Name	City	State
United States	Nevro Corp	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Nevro Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS)	Percentage change in back pain	24 months
Other	Observational Outcomes on disability using Oswestry Disability Index scores	Percentage change from Baseline in ODI score	24 months
Other	Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire	Change in quality of life index compared to baseline	24 months
Primary	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	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	6 months
Secondary	Percentage change from baseline in back pain intensity (as assessed by VAS)		6 months
Secondary	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".	6 months
Secondary	Global impression of change	Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire	6 months
Secondary	Change from baseline in opioid equivalent medication usage in each group		6 months
Secondary	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.	3, 6 and 12 months
Secondary	Incidences of adverse events		3, 6 and 12 months