Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HF10 Treatment of Chronic Knee Pain (CPSP-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020211
Recruitment Status : Terminated (Limited Enrollment)
First Posted : July 15, 2019
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Nevro Corp

Brief Summary:
This is a multi-center study where patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery. The primary endpoint will be assessed at 3 months, but observational assessments will continue until study completion at 12 months following implant.

Condition or disease Intervention/treatment
Chronic Pain Post-Procedural Device: Senza HF10 Therapy

Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HF10 Therapy for the Treatment of Chronic, Focal, Neuropathic Pain Following Orthopedic Surgical Intervention of the Knee(s) - A Multicenter, Prospective Clinical Trial
Actual Study Start Date : March 14, 2019
Actual Primary Completion Date : December 12, 2019
Actual Study Completion Date : December 12, 2019

Group/Cohort Intervention/treatment
HF10
SCS stimulation with HF10 therapy
Device: Senza HF10 Therapy
Senza 10kHz Spinal Cord Stimulation
Other Name: Nevro Senza Spinal Cord Stimulation (SCS)




Primary Outcome Measures :
  1. Responders and Improvement in Oxford Knee Score (OKS) [ Time Frame: 3 months ]
    The OKS is a patient self-completion patient reported outcome containing 12 questions on activities of daily living with a recall period of 4 weeks. The OKS has been developed and validated specifically to assess function and pain after total knee replacement. The higher the score indicates improvement. The proportion of implanted subjects who are responders (achieved ≥ 50% pain relief) to HF10 therapy for treatment of their chronic, post-surgical knee pain or reporting at least a 4-point improvement in their Oxford Knee Score (OKS).


Secondary Outcome Measures :
  1. Change in Disability and Functioning [ Time Frame: 3, 6, and 12 months ]
    Percentage and average change from Baseline in Oxford Knee Score

  2. Change in Functioning [ Time Frame: 3 and 12 months ]
    Average change in walking distance assessed by 6-minute Walk Test

  3. Change in Functioning [ Time Frame: 3 and 12 months ]
    Change in Global Assessment of Functioning

  4. Change in pain relief as measured by the Visual Analog Scale (VAS) [ Time Frame: 3 and 12 months ]
    Percentage and average change from Baseline in knee pain intensity

  5. Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores [ Time Frame: 3 and 12 months ]

    The Short Form McGill Pain Questionnaire version 2 (SF-MPQ-2, hereafter referred to as MPQ) is a well validated and widely used questionnaire used to measure the major symptoms of pain. Subjects will be asked to rate the intensity of each of 22 pain descriptors from 0 (do not experience, or none) to 10 (worst possible) at follow-up visits outlined in the schedule of events.

    Four subscale scores (continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors) and a total score will be calculated. The lower the score indicates improvement (less interference from pain). Each subject's baseline scores will be compared to the scores at study visits. Mean change from baseline will be calculated for the entire cohort.

    Percentage and average change from Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores


  6. Global Impression of Change [ Time Frame: 3 and 12 months ]
    Subject's impression of change in overall health condition as measured by the Patient and Clinician Global Impression of Change

  7. Change in Quality of Life as measured by the EuroQol five-dimensional questionnaire (EQ-5D-5L) [ Time Frame: 3 and 12 months ]
    The 5-level EQ-5D version (EQ-5D-5L) uses a 2-part assessment: a descriptive one and a visual analog scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The higher the score indicates an improved in quality of life. Change from Baseline in health-related quality of life evaluation

  8. Change in Sleep as measured by the Pain and sleep Questionnaire (PSQ) [ Time Frame: 3 and 12 months ]
    PSQ is an eight-item questionnaire developed to assess the impact of pain on sleep. PSQ-3 is a subset of PSQ, consisting of questions 1, 4 and 5 and has been validated to assess impact of chronic pain on sleep. The lower the score indicates improvement by less interference of sleep from pain. Change from baseline in 3-item pain and sleep questionnaire

  9. Medication [ Time Frame: 3 and 12 months ]
    Change from baseline in opioid equivalent medication usage

  10. Safety profile: Incidence of AEs over time [ Time Frame: 3, 6 and 12 months ]
    Incidence of AEs over time

  11. Safety profile: Neurological assessment over time by a physician and exam [ Time Frame: 3, 6 and 12 months ]
    Neurologic status includes testing for gross motor, sensory and appropriate reflex functions, which will be characterized as improved, maintained, or a deficit as compared with baseline status as follows: A clinically meaningful neurological improvement is defined as a significant persistent improvement in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or improved as compared with the baseline assessment. A clinically meaningful neurological deficit is defined as a stimulation-related significant persistent abnormality in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or worsened as compared with the baseline assessment. If neither a clinically meaningful neurological improvement nor a clinically meaningful neurological deficit is observed, then neurologic status is maintained.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery.
Criteria

Key Inclusion Criteria:

  1. Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
  2. Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.
  3. Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
  4. Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
  5. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
  6. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.

Key Exclusion Criteria:

  1. Have radiculopathy or radicular leg pain resulting from failed back surgery.
  2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia).
  3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.
  4. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the Investigator.
  5. Have any prior experience with SCS.
  6. Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
  7. Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
  8. Have an existing drug pump and/or another active implantable device such as a pacemaker.
  9. Be involved in an injury claim under current litigation.
  10. Have an active or unsettled 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): NCT04020211


Locations
Layout table for location information
United States, Wisconsin
Pain Management
Greenfield, Wisconsin, United States, 53221
Sponsors and Collaborators
Nevro Corp
Investigators
Layout table for investigator information
Study Director: David Caraway, MD Chief Medical Officer
Layout table for additonal information
Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT04020211    
Other Study ID Numbers: CA2018-5 US CPSP-3
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

Layout table for additional information
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.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations