Chronic Pain Post-ProceduralCPSP-3NCT04020211
HF10 Treatment of Chronic Knee Pain
An observational study of Chronic Pain Post-Procedural, run by Nevro Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Post-Procedural
- What is being tested?
- Senza HF10 Therapy
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery.
Who may be able to join
- Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
- 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.
- Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
- Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
- Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
- 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.
Who cannot join
- Have radiculopathy or radicular leg pain resulting from failed back surgery.
- 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).
- 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.
- 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.
- Have any prior experience with SCS.
- Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
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- Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
- Have an existing drug pump and/or another active implantable device such as a pacemaker.
- Be involved in an injury claim under current litigation.
- Have an active or unsettled worker's compensation claim.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Pain Post-Procedural
- Being tested
- Senza HF10 Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senza HF10 TherapyDevice
Also called Nevro Senza Spinal Cord Stimulation (SCS)
Senza 10kHz Spinal Cord Stimulation
| Study group | Role | What they receive |
|---|---|---|
| HF10 | SCS stimulation with HF10 therapy Receives: Device: Senza HF10 Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (11)
Change in Disability and Functioning
Percentage and average change from Baseline in Oxford Knee Score
Measured: 3, 6, and 12 months
Change in Functioning
Average change in walking distance assessed by 6-minute Walk Test
Measured: 3 and 12 months
Change in Functioning
Change in Global Assessment of Functioning
Measured: 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
Measured: 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
Measured: 3 and 12 months
Global Impression of Change
Subject's impression of change in overall health condition as measured by the Patient and Clinician Global Impression of Change
Measured: 3 and 12 months
Change in Quality of Life as measured by the EuroQol five-dimensional questionnaire (EQ-5D-5L)
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
Measured: 3 and 12 months
Change in Sleep as measured by the Pain and sleep Questionnaire (PSQ)
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
Measured: 3 and 12 months
Medication
Change from baseline in opioid equivalent medication usage
Measured: 3 and 12 months
Safety profile: Incidence of AEs over time
Incidence of AEs over time
Measured: 3, 6 and 12 months
Safety profile: Neurological assessment over time by a physician and exam
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.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start14 Mar 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Why it stopped: Limited Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain Post-ProceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevro Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Caraway, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020211
- Sponsor's protocol ID
- CA2018-5 US CPSP-3
- Acronym
- CPSP-3
- Status last verified
- Nov 2020
- First submitted
- 9 Apr 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04020211
- Acronym / sponsor ID
- CPSP-3 / CA2018-5 US CPSP-3
- Conditions
- Chronic Pain Post-Procedural
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Limited Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nevro CorpIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF10 | – | Device: Senza HF10 TherapySCS stimulation with HF10 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery.
Key inclusion criteria (6 listed)
- Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
- 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.
- Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
- Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
- Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
Key exclusion criteria (10 listed)
- Have radiculopathy or radicular leg pain resulting from failed back surgery.
- 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).
- 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.
- 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.
- Have any prior experience with SCS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senza HF10 TherapyAlso: Nevro Senza Spinal Cord Stimulation (SCS)Senza 10kHz Spinal Cord Stimulation | Device | HF10 |
Primary outcome
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).
11 secondary outcomes
Change in Disability and Functioning
Time frame: 3, 6, and 12 months
Change in Functioning
Time frame: 3 and 12 months
Change in Functioning
Time frame: 3 and 12 months
Change in pain relief as measured by the Visual Analog Scale (VAS)
Time frame: 3 and 12 months
Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores
Time frame: 3 and 12 months
Global Impression of Change
Time frame: 3 and 12 months
Change in Quality of Life as measured by the EuroQol five-dimensional questionnaire (EQ-5D-5L)
Time frame: 3 and 12 months
Change in Sleep as measured by the Pain and sleep Questionnaire (PSQ)
Time frame: 3 and 12 months
Medication
Time frame: 3 and 12 months
Safety profile: Incidence of AEs over time
Time frame: 3, 6 and 12 months
Safety profile: Neurological assessment over time by a physician and exam
Time frame: 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Limited Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Caraway, MD study director
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Post-Procedural, run by Nevro Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Limited Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders and Improvement in Oxford Knee Score (OKS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.