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

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ClinicalTrials.gov Identifier: NCT03680846
Recruitment Status : Active, not recruiting
First Posted : September 21, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Back Pain Device: HF10 Therapy Other: CMM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : October 6, 2020
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
CMM
Conventional Medical Management
Other: CMM
Conventional Medical Management

Active Comparator: HF10 + CMM
Addition of HF10 therapy to CMM
Device: HF10 Therapy
Senza 10 kHz Spinal Cord Stimulation

Other: CMM
Conventional Medical Management




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680846


Locations
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United States, California
Nevro Corp
Redwood City, California, United States, 94065
Sponsors and Collaborators
Nevro Corp
Investigators
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Study Director: David Caraway, MD Nevro Corp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT03680846    
Other Study ID Numbers: CA2018-2 US NSRBP
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations