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 range38 Years
SexALL
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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
✕. 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
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