Osteoarthritic Knee PainNCT03877653
Freedom-1 Study for Chronic Knee Pain
A study testing Wireless neuromodulation in people with Osteoarthritic Knee Pain, run by Curonix LLC at 13 sites in United States.
Trial summary
To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritic Knee Pain
- What is being tested?
- Wireless neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Sep 2021to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS >6/10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and/or oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.
Who cannot join
- Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his/her enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Austin Orthopedic Institute
Austin, Texas, 78759
Earl Kilbride, DO
- Recruiting
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, 45459
Laura Peterson, 937-439-6483, lpeterson@oaswo.com
Jonathan Silverman, MD
- Recruiting
Colorado Pain Care, LLC
Denver, Colorado, 80222
Joe Mitchell, 303-756-3245, Joe.Mitchell@coloradopaincare.com
Robert Moghim, MD
- Recruiting
Holy Cross Hospital, Inc
Fort Lauderdale, Florida, 33308
Lindita Burba, 954-229-7965, lindita.burba@holy-cross.com
Paul Wu, MD
- Recruiting
Performance pain and sports medicine
Houston, Texas, 77027
Amber Pulis, 346-217-1111, apulis@performancepainhouston.com
Matthias Wiederholz, MD
- Recruiting
Southern Pain and research
Jasper, Georgia, 30143
Julianna Kirby, (678) 971-4167, jkirby@southernpainandspine.com
Jordan Tate, MD
- Recruiting
Desert Orthopaedic Center
Las Vegas, Nevada, 89149
Paul Gastelum, 725-706-7860, pgastelum@doclv.com
Sungkook park, MD
- Recruiting
Premier Pain Treatment
Loveland, Ohio, 45140
Kathy P White, 5134547246, kwhite@premierpaintreatment.com
Michael Danko, MD
- Recruiting
Kettering Health
Miamisburg, Ohio, 45429
Machelle Gonzalez, 9373844511, machelle.gonzalez@ketteringhealth.org
Nirmala Abraham, MD
- Recruiting
Vista Clinical Research/Summit Spine & Joint Centers
Newnan, Georgia, 30265
Debra Helton, 770-755-6914, dhelton@vistaclinresearch.com
Sandeep Vaid, DO
- Recruiting
Western Clinical Research
Placentia, California, 92870
Jessica Lynch, 714-223-7000 ext. 124, research@ocpain.net
Albert Lai, MD
- Recruiting
Advanced Spine and Pain Center
San Antonio, Texas, 78240
Sofia Sued, 210-690-0777, sofia.sued@gmail.com
Ellen Lin, MD
- Recruiting
Florida Joint Care Institute
Trinity, Florida, 34655
Isabel JC Freeman, 7273726637, ifreeman@floridajointcare.com
Aaron Mates, DO
About this study
Official title: Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation
To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.
Read the detailed description
Screening and Patient Selection Subjects will be selected from the pool patients of routine care who meet all the inclusion criteria for this study and none of the exclusion criteria, as described in Section 9.3.
Candidates will be given a patient information sheet (or Informed Consent) either in clinic or sent via post. Each approached candidate will be logged, assigned a screening number, and evaluated by the site research team. Subjects who sign the Informed Consent for participation and meet the Inclusion and Exclusion criteria will be enrolled and listed with an enrollment number. Recruitment will continue competitively until at least 84 subjects have evaluable data for evaluation of the primary endpoint.
Average pain levels will be captured at screening/baseline. Diagnostic Injection A diagnostic injection of the IPS under ultrasound, fluoroscopy or landmark guided in the clinic will be performed administering no more than 2cc of anesthetic. No steroids are allowed for the diagnostic injection. Only those subjects with significant temporary pain relief (> 75%) compared to the average pain level captured at baseline, and after at least 2 hours of the injection, will be allowed to continue with the study.
Trial Implant All subjects will be brought to the procedure room or operating room (OR) for the trial implant procedure under local anesthetic. An introducer will be placed under ultrasound or fluoroscopic guidance at the target nerve and the electrodes percutaneously advanced towards the IPS. After insertion of the receiver and then confirmation of stimulation, the trial stimulator will be secured to the skin. The stimulator tail will be outside the body and attached to the skin. All subjects will undergo an active 7-day provisional test period. Only those subjects reporting > 50% pain relief at the end of the 7-day provisional test period as compared to the average pain level captured at baseline will be allowed to continue with the study. The trial leads will be removed at the end of 7 days.
Permanent Implant All subjects responding to therapy with > 50% pain relief at 7 days will, at a later date, be brought to the operating room (OR) and given a sedative and local anesthetic for implantation of a permanent electrode. An introducer will be placed under ultrasound or fluoroscopic guidance onto the target nerve and the electrode array advanced towards the nerve. The receiver will be mated with the electrode array, and, after confirmation of stimulation, the permanent stimulator will be tunneled and secured. The device will remain inactive for 10 days to allow for satisfactory healing. If no localized infection or other complication, subjects can be brought back to the office for randomization.
Randomization/Blinding Subjects will be randomized to either active sub-threshold (high frequency) stimulation or no stimulation (sham) by Curonix's Clinical Support. All subjects, the investigator and the research team will be blinded to the group assignment for up to 30 days from the moment of randomization.
Office Study Visits After randomization follow-up visits will be conducted at 1 week, 1 month, 3 months, and 6 months.
Initial and follow-up evaluations will consist of physical exams, pain scale (m-MPS), Knee Injury \& Osteoarthritis Outcome Score Junior (KOOS Jr), range of motion (flexion and extension measured by goniometer, work status and medication intake evaluation. At 1-month post-randomization, all subjects will be unblinded. Active devices can be adjusted for optimal pain relief. Sham devices will be reprogrammed to receive active treatment.
Available stimulation programs include tonic (on table testing), 500 Hz, 1000 Hz 1499 Hz frequency stimulation, all of which may be utilized on the same subject.
Remote Study Visits Follow up phone calls at 12 months, 18 months, and 24 months post-implantation will be performed to confirm durability of pain relief with the m-MPS and the global perceived effects scale (GPES). Any adverse events will be assessed and captured as part of the study.
- Conditions
- Osteoarthritic Knee Pain
- Being tested
- Wireless neuromodulation
- Keywords
- PNS, Chronic, Pain, Wireless, Neuromodulation, knee, osteoarthritic, peripheral nerve stimulation, infra patellar saphenous
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless neuromodulationDevice
A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Single arm, active stimulation Receives: Device: Wireless neuromodulation |
| Placebo | Placebo comparator | When receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation.
Sites will not have access to WaveCrest programmer. Study devices can only be programmed by Stimwave representatives. Receives: Device: Wireless neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
- Percentage of patients with at least 50% improvement in the knee pain identified at baseline compared to 3 months post full implant of the StimQ PNS System pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS
Measured: 1 month
Secondary outcomes (10)
Mankoski pain scale
The Mankoski Pain Scale is a numerical scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. As pain is a subjective experience and individuals may interpret the severity of their pain differently, the MPS includes descriptions of each level of pain intensity to standardize the pain interpretation across subjects enrolled in this study.
Measured: 1 month
Koos Jr
The KOOS assesses patient knee pain, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, useful for assessing changes in knee pathology over time, with or without treatment
Measured: 1 month
Global Perceived Effect scales (GPES)
Patient satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best) Scale from 1 (no change) to 7 (a great deal better) describing improvement with therapy
Measured: 1 month
McGill Short Form (SF-MPQ-2)
The SF-MPQ-2 is a patient self-reported depression and pain quality questionnaire consisting of 22 questions, with all questions scored on a scale of 0 to 10. Answers on a scale of 0 (none) to 10 (worst possible)
Measured: 1 month
Neuropathic pain questionnaire (DN4)
The DN4 is a patient self-reported questionnaire designed to evaluate to degree of neuropathic pain. There are 10 questions on a scale of 0 (No) to 1 (Yes). Scores equal or higher than 4 out of 10 are an indication for the presence of neuropathic pain.
Measured: baseline
Work status (if working);
Work history and status will be evaluated based on a patient's self-reported questionnaire(s) completed at screening/baseline and all follow up visits.
Measured: 1 month
Percentage Increase in Ability to do Knee Bends and Walking Tolerance
The patients will be evaluated for knee bends and walking tolerance before and after the treatment, using a treadmill for distance. Scale in degrees and (k)meters
Measured: 1 month
Range of Motion
The passive and active range of motion will be measures with a goniometer.
Measured: 1 month
Timed Up & Go (TUG)
This test assesses mobility. The patient sits back in a standard armchair, and identifies a line on the floor 3 meters (10 feet) away. When the examiner says "go", the patient is timed to see how long it takes to get up out of the chair, walk to the line, turn around, come back to the chair and sit down
Measured: 1 month
Medication: Change in concomitant pain medication usage
Measure a change in concomitant pain medication usage.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Sep 2021
- Primary completionOct 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritic Knee PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled double blinded randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Institute for Pain and spine, Performance Pain and Sports Medicine PLLC, Holy Cross Hospital, Inc, Colorado pain Care, LLC, Advanced Spine and Pain, Desert Orthopaedic Institute, Vista Clinical Research, Premier Pain Treatment, Florida Joint Pain Institute, Austin Orthopedic Institute, Kettering Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877653
- Sponsor's protocol ID
- 30-00946
- Other IDs
- Freedom-1
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation
- ClinicalTrials.gov ID
- NCT03877653
- Acronym / sponsor ID
- 30-00946
- Conditions
- Osteoarthritic Knee Pain
- Keywords
- PNS, Chronic, Pain, Wireless, Neuromodulation, knee, osteoarthritic, peripheral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Collaborators
- Texas Institute for Pain and spine, Performance Pain and Sports Medicine PLLC, Holy Cross Hospital, Inc, Colorado pain Care, LLC, Advanced Spine and Pain, Desert Orthopaedic Institute, Vista Clinical Research, Premier Pain Treatment, Florida Joint Pain Institute, Austin Orthopedic Institute, Kettering Health
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Mar 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.
To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.
Detailed description
Screening and Patient Selection Subjects will be selected from the pool patients of routine care who meet all the inclusion criteria for this study and none of the exclusion criteria, as described in Section 9.3.
Candidates will be given a patient information sheet (or Informed Consent) either in clinic or sent via post. Each approached candidate will be logged, assigned a screening number, and evaluated by the site research team. Subjects who sign the Informed Consent for participation and meet the Inclusion and Exclusion criteria will be enrolled and listed with an enrollment number. Recruitment will continue competitively until at least 84 subjects have evaluable data for evaluation of the primary endpoint.
Average pain levels will be captured at screening/baseline. Diagnostic Injection A diagnostic injection of the IPS under ultrasound, fluoroscopy or landmark guided in the clinic will be performed administering no more than 2cc of anesthetic. No steroids are allowed for the diagnostic injection. Only those subjects with significant temporary pain relief (> 75%) compared to the average pain level captured at baseline, and after at least 2 hours of the injection, will be allowed to continue with the study.
Trial Implant All subjects will be brought to the procedure room or operating room (OR) for the trial implant procedure under local anesthetic. An introducer will be placed under ultrasound or fluoroscopic guidance at the target nerve and the electrodes percutaneously advanced towards the IPS. After insertion of the receiver and then confirmation of stimulation, the trial stimulator will be secured to the skin. The stimulator tail will be outside the body and attached to the skin. All subjects will undergo an active 7-day provisional test period. Only those subjects reporting > 50% pain relief at the end of the 7-day provisional test period as compared to the average pain level captured at baseline will be allowed to continue with the study. The trial leads will be removed at the end of 7 days.
Permanent Implant All subjects responding to therapy with > 50% pain relief at 7 days will, at a later date, be brought to the operating room (OR) and given a sedative and local anesthetic for implantation of a permanent electrode. An introducer will be placed under ultrasound or fluoroscopic guidance onto the target nerve and the electrode array advanced towards the nerve. The receiver will be mated with the electrode array, and, after confirmation of stimulation, the permanent stimulator will be tunneled and secured. The device will remain inactive for 10 days to allow for satisfactory healing. If no localized infection or other complication, subjects can be brought back to the office for randomization.
Randomization/Blinding Subjects will be randomized to either active sub-threshold (high frequency) stimulation or no stimulation (sham) by Curonix's Clinical Support. All subjects, the investigator and the research team will be blinded to the group assignment for up to 30 days from the moment of randomization.
Office Study Visits After randomization follow-up visits will be conducted at 1 week, 1 month, 3 months, and 6 months.
Initial and follow-up evaluations will consist of physical exams, pain scale (m-MPS), Knee Injury \& Osteoarthritis Outcome Score Junior (KOOS Jr), range of motion (flexion and extension measured by goniometer, work status and medication intake evaluation. At 1-month post-randomization, all subjects will be unblinded. Active devices can be adjusted for optimal pain relief. Sham devices will be reprogrammed to receive active treatment.
Available stimulation programs include tonic (on table testing), 500 Hz, 1000 Hz 1499 Hz frequency stimulation, all of which may be utilized on the same subject.
Remote Study Visits Follow up phone calls at 12 months, 18 months, and 24 months post-implantation will be performed to confirm durability of pain relief with the m-MPS and the global perceived effects scale (GPES). Any adverse events will be assessed and captured as part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled double blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Wireless neuromodulationSingle arm, active stimulation |
| Placebo | Placebo comparator | Device: Wireless neuromodulationWhen receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation. Sites will not have access to WaveCrest programmer. Study devices can only be programmed by Stimwave representatives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS >6/10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and/or oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.
Key exclusion criteria (1 listed)
- Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his/her enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.
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 |
|---|---|---|
| Wireless neuromodulationA needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration. | Device | Interventional, Placebo |
Primary outcome
Responder rate
Time frame: 1 month
A. Percentage of patients with at least 50% improvement in the knee pain identified at baseline compared to 3 months post full implant of the StimQ PNS System pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS
10 secondary outcomes
Mankoski pain scale
Time frame: 1 month
Koos Jr
Time frame: 1 month
Global Perceived Effect scales (GPES)
Time frame: 1 month
McGill Short Form (SF-MPQ-2)
Time frame: 1 month
Neuropathic pain questionnaire (DN4)
Time frame: baseline
Work status (if working);
Time frame: 1 month
Percentage Increase in Ability to do Knee Bends and Walking Tolerance
Time frame: 1 month
Range of Motion
Time frame: 1 month
Timed Up & Go (TUG)
Time frame: 1 month
Medication: Change in concomitant pain medication usage
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless neuromodulation in people with Osteoarthritic Knee Pain, run by Curonix LLC at 13 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niek Vanquathem, BA (0032 492 69 22 23, niekv@stimwavefreedom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate (time frame: 1 month). 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 13 Feb 2025.