HF10 Treatment of Chronic Knee Pain

N/ATerminatedNCT04020211

Nevro Corp3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pain Post-Procedural

Interventions

Senza HF10 TherapyDEVICE

Senza 10kHz Spinal Cord Stimulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pain Management

Greenfield, Wisconsin, United States

Outcomes

Primary Outcomes

Responders and Improvement in Oxford Knee Score (OKS)

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).

Time frame: 3 months

Secondary Outcomes

Change in Disability and Functioning

Percentage and average change from Baseline in Oxford Knee Score

Time frame: 3, 6, and 12 months

Change in Functioning

Average change in walking distance assessed by 6-minute Walk Test

Time frame: 3 and 12 months

Change in Functioning

Change in Global Assessment of Functioning

Time frame: 3 and 12 months

Change in pain relief as measured by the Visual Analog Scale (VAS)

Percentage and average change from Baseline in knee pain intensity

Time frame: 3 and 12 months

Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores

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

Data from ClinicalTrials.gov

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