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NCT03877653 · ClinicalTrials.gov registry record · NA
Freedom-1 Study for Chronic Knee Pain
A NA study of Osteoarthritic Knee Pain, sponsored by Curonix.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 13
- Study locations
NCT03877653: Recruiting NA study of Osteoarthritic Knee Pain, sponsored by Curonix.
NCT03877653 is a NA study of Osteoarthritic Knee Pain that is actively recruiting participants, run by Curonix. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03877653, a NA study of Osteoarthritic Knee Pain, is actively recruiting participants, sponsored by Curonix.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 13
- Study locations
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Wireless neuromodulation
Study Locations (13)
Ohio
- Orthopedic Associates of Southwest Ohio - Dayton
- Premier Pain Treatment - Loveland
- Kettering Health - Miamisburg
Texas
- Austin Orthopedic Institute - Austin
- Performance pain and sports medicine - Houston
- Advanced Spine and Pain Center - San Antonio
Florida
- Holy Cross Hospital, Inc - Fort Lauderdale
- Florida Joint Care Institute - Trinity
Georgia
- Southern Pain and research - Jasper
- Vista Clinical Research/Summit Spine & Joint Centers - Newnan
California
- Western Clinical Research - Placentia
Colorado
- Colorado Pain Care, LLC - Denver
Nevada
- Desert Orthopaedic Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT03877653 shows while recruiting
NCT03877653 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Osteoarthritic Knee Pain appearing as the primary indexed condition, and to 1 intervention - of which Wireless neuromodulation is the first listed.
NCT03877653 lists 13 locations in 7 states (Ohio, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT03877653 about?
NCT03877653 is a clinical study titled "Freedom-1 Study for Chronic Knee Pain". 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...
What is the current status of trial NCT03877653?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-09-01. Estimated completion is 2027-06.
What conditions does trial NCT03877653 study?
This clinical trial studies the following conditions: Osteoarthritic Knee Pain.
What interventions are being tested in trial NCT03877653?
The interventions under investigation include: Wireless neuromodulation (DEVICE).
Who is sponsoring clinical trial NCT03877653?
This trial is sponsored by Curonix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03877653 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Georgia, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03877653's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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