Actively Recruiting
Double-Blinded Randomized Control Trial of Knee Pain Using Sub-Threshold Peripheral Nerve Stimulation
Led by Curonix LLC · Updated on 2025-02-13
100
Participants Needed
13
Research Sites
86 weeks
Total Duration
On this page
Sponsors
C
Curonix LLC
Lead Sponsor
T
Texas Institute for Pain and spine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits and risks of active sub-threshold wireless neuromodulation stimulation for treating chronic knee pain caused by osteoarthritis. This trial aims to compare active stimulation versus no stimulation (sham) in reducing pain, with the primary goal of measuring the number of participants who experience at least a 50% decrease in pain on a visual analog scale after one month. Participants first undergo a diagnostic injection to confirm temporary pain relief before receiving a 7-day trial implant of the stimulation device near the target nerve. Those reporting more than 50% pain relief during this test proceed to receive a permanent implant under sedation. After a healing period of 10 days, participants are randomized to receive either active sub-threshold stimulation or sham stimulation for 30 days while both participants and staff remain unaware of group assignments. Stimulation programs include various high-frequency options. Throughout the study, participants attend in-person visits at 1 week, 1 month, 3 months, and 6 months post-randomization for physical exams, pain scales, knee function assessments, range of motion, work status, and medication use. Additional phone follow-ups are conducted at 12, 18, and 24 months to assess long-term pain relief and any adverse events. The study collects multiple outcome measures to evaluate the treatment's impact on pain and physical function over time.
CONDITIONS
Brief Title
Freedom-1 Study for Chronic Knee Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is over 18 years of age
- Chronic knee pain from osteoarthritis lasting at least three months with a modified Mankoski Pain Scale score greater than 6/10
- Diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis confirmed by X-ray within the last year
- Appropriate candidate for the procedure, including post-total knee replacement patients
- Able to understand and voluntarily consent to participate
- Willing and able to comply with study procedures and follow-up visits
- Documented failure of at least two less invasive treatments such as physical therapy, steroids, or NSAIDs
- No recent invasive knee procedures within specific timeframes before consent
- Experienced more than 75% temporary pain relief from a local anesthetic nerve injection
- Deemed neuro-psycho-socially appropriate for implantation by a clinical psychologist
You will not qualify if you...
- Significant pain in the opposite knee affecting activity level
- Hip or foot pain greater than knee pain
- Neurogenic or vascular claudication
- Diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis
- Uncontrolled major depression or psychiatric disorders
- Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, liver dysfunction, neurological deficits, infection, unstable angina, severe COPD
- Chronic severe conditions interfering with pain or function assessments
- Pregnant, planning pregnancy, or lactating women
- Body mass index greater than 40
- Multiple overlapping knee, foot, ankle, or radicular pain complaints
- Anatomical restrictions making procedure inappropriate
- Conditions compromising surgical site such as lymphedema or ulcers
- History of adverse reaction to local anesthetics
- Worker's compensation claimants
- Incarcerated individuals or those with ankle position locators
- Allergy to device materials
- Substance abuse within the last 2 years
- Pacemaker or implanted defibrillator
- Participation in conflicting clinical studies
- Any legal or medical concerns preventing enrollment
- Presence of other active implanted medical devices at the study site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a diagnostic injection near the knee nerve to assess temporary pain relief.
1 visit (in-person)
Duration - 7 days
Participants undergo a trial implant procedure with a temporary stimulator for a 7-day test period to evaluate pain relief.
1 procedure visit and daily use for 7 days
Duration - Procedure day plus 10 days
Participants with positive response receive permanent implantation of the stimulator device, followed by a 10-day healing period.
1 procedure visit and healing period with no device activation
Duration - Up to 30 days
Participants are randomized to receive active or sham stimulation, remaining blinded for up to 30 days while using the device.
1 visit for randomization plus device use during this period
Duration - 6 months
Participants attend follow-up visits for physical exams, pain assessment, and device adjustments with unblinding at 1 month.
Visits at 1 week, 1 month, 3 months, and 6 months (in-person)
Duration - Up to 24 months post-implantation
Participants complete remote follow-up phone calls to assess long-term pain relief and any adverse events.
Phone calls at 12, 18, and 24 months
Trial Site Locations
Total: 13 locations
1
Western Clinical Research
Placentia, California, United States, 92870
Actively Recruiting
2
Colorado Pain Care, LLC
Denver, Colorado, United States, 80222
Actively Recruiting
3
Holy Cross Hospital, Inc
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
4
Florida Joint Care Institute
Trinity, Florida, United States, 34655
Actively Recruiting
5
Southern Pain and research
Jasper, Georgia, United States, 30143
Actively Recruiting
6
Vista Clinical Research/Summit Spine & Joint Centers
Newnan, Georgia, United States, 30265
Actively Recruiting
7
Desert Orthopaedic Center
Las Vegas, Nevada, United States, 89149
Actively Recruiting
8
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, United States, 45459
Actively Recruiting
9
Premier Pain Treatment
Loveland, Ohio, United States, 45140
Actively Recruiting
10
Kettering Health
Miamisburg, Ohio, United States, 45429
Actively Recruiting
11
Austin Orthopedic Institute
Austin, Texas, United States, 78759
Actively Recruiting
12
Performance pain and sports medicine
Houston, Texas, United States, 77027
Actively Recruiting
13
Advanced Spine and Pain Center
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
N
Niek Vanquathem, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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