Condition or disease | Intervention/treatment |
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Chronic Pain Post-Procedural | Device: Senza HF10 Therapy |
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 |
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HF10
SCS stimulation with HF10 therapy
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Device: Senza HF10 Therapy
Senza 10kHz Spinal Cord Stimulation
Other Name: Nevro Senza Spinal Cord Stimulation (SCS)
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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
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, Wisconsin | |
Pain Management | |
Greenfield, Wisconsin, United States, 53221 |
Study Director: | David Caraway, MD | Chief Medical Officer |
Tracking Information | |||||||
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First Submitted Date | April 9, 2019 | ||||||
First Posted Date | July 15, 2019 | ||||||
Last Update Posted Date | November 12, 2020 | ||||||
Actual Study Start Date | March 14, 2019 | ||||||
Actual Primary Completion Date | December 12, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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).
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | HF10 Treatment of Chronic Knee Pain | ||||||
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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition | Chronic Pain Post-Procedural | ||||||
Intervention | Device: Senza HF10 Therapy
Senza 10kHz Spinal Cord Stimulation
Other Name: Nevro Senza Spinal Cord Stimulation (SCS)
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Study Groups/Cohorts | HF10
SCS stimulation with HF10 therapy
Intervention: Device: Senza HF10 Therapy
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Terminated | ||||||
Actual Enrollment |
3 | ||||||
Original Estimated Enrollment |
75 | ||||||
Actual Study Completion Date | December 12, 2019 | ||||||
Actual Primary Completion Date | December 12, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04020211 | ||||||
Other Study ID Numbers | CA2018-5 US CPSP-3 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Nevro Corp | ||||||
Study Sponsor | Nevro Corp | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Nevro Corp | ||||||
Verification Date | November 2020 |