HF10 Treatment of Chronic Knee Pain (CPSP-3)
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|ClinicalTrials.gov Identifier: NCT04020211|
Recruitment Status : Terminated (Limited Enrollment)
First Posted : July 15, 2019
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment|
|Chronic Pain Post-Procedural||Device: Senza HF10 Therapy|
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|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|
SCS stimulation with HF10 therapy
Device: Senza HF10 Therapy
Senza 10kHz Spinal Cord Stimulation
Other Name: Nevro Senza Spinal Cord Stimulation (SCS)
- 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).
- Change in Disability and Functioning [ Time Frame: 3, 6, and 12 months ]Percentage and average change from Baseline in Oxford Knee Score
- Change in Functioning [ Time Frame: 3 and 12 months ]Average change in walking distance assessed by 6-minute Walk Test
- Change in Functioning [ Time Frame: 3 and 12 months ]Change in Global Assessment of Functioning
- 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
- 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
- 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
- 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
- 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
- Medication [ Time Frame: 3 and 12 months ]Change from baseline in opioid equivalent medication usage
- Safety profile: Incidence of AEs over time [ Time Frame: 3, 6 and 12 months ]Incidence of AEs over time
- 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.
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
|United States, Wisconsin|
|Greenfield, Wisconsin, United States, 53221|
|Study Director:||David Caraway, MD||Chief Medical Officer|