Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
Greece60 participantsStarted 2025-11-24
Plain-language summary
The aim of this study is to test whether the addition of dextrose to perineural injections is superior to local anesthetic alone, as some initial data have indicated. To enhance the potential therapeutic effect, we will proceed to a 4-point injection technique, targeting 4 genicular nerves (superomedial, superolateral, inferomedial, recurrent peroneal genicular nerve) in a randomized controlled trial with two arms.
Who can participate
Age range
38 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients of both sexes
. Age \>38 years
. Body Mass Index (BMI) up to 42 kg/m2
. Diagnosis of knee osteoarthritis, according to the clinical criteria of the American College of Rheumatology. Osteoarthritis if the following combinations are present:
. Chronic knee pain on the Numerical Rating Scale (NRS) \> 5 for at least 3 months prior to the study
. Grade 2 or 3 osteoarthritis, according to the Kellgern-Lawrence classification
. Pain, creaking, and stiffness in the knee joint that persists for at least three months prior to the study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Severity Score (PSS) at 15 days after the 3rd (last) infiltration
Timeframe: 15 days after the 3rd infiltration of the first participant up to 15 days after the 3rd infiltration of the last participant
Trial details
NCT IDNCT07245121
SponsorNational and Kapodistrian University of Athens
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12
Contact for this trial
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
. Any infection of the skin of the knee joint, such as cellulitis, or periarticular or intraarticular infection during the last 3 months
. Poorly controlled diabetes mellitus or connective tissue disease affecting the knee joint
. History of previous total knee arthroplasty or other knee surgery.
. History of periarticular or intraarticular injection of corticosteroids, local anesthetic, hyaluronic acid, platelet-rich plasma, radiofrequency, prolotherapy within the last trimester
. History of knee injury or fracture within the last 3 months
. History of acute lumbosacral radiculopathy or peripheral neuropathy, neurological, psychiatric disease
. Pain limited in the posterior aspect of the knee