RecruitingNot ApplicableNCT07245121

Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.

Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial.

Sponsor

National and Kapodistrian University of Athens

Enrollment

60 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Chronic Pain Prolotherapy Perineural Analgesia

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.

Eligibility

Min Age: 38 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting a mixture of dextrose (sugar solution) and local anesthetic around specific nerves near the knee provides better pain relief than local anesthetic alone for people with chronic knee osteoarthritis pain. The technique, called perineural prolotherapy, targets four small nerves around the knee using ultrasound guidance to precisely deliver the injections. Adults aged 38 or older with moderate knee osteoarthritis (grade 2 or 3), chronic knee pain of at least 3 months, and who have not responded to at least 3 months of conservative treatment may be eligible. Participation involves three injection sessions over four weeks and follow-up assessments of pain and function at 15, 30, and 90 days after treatment. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextrose 5% and Lidocaine

In the Dextrose + Lidocaine group (group D+L) a perineural infusion of a total volume of 8 ml of DW 5% and lidocaine 1% will be performed at the 4 genicular nerves (2ml per nerve), which will be prepared as follows: 4 ml of lidocaine 2%, with 1.2 ml of DW 35% and 2.8 ml of NaCl 0.9%. All perineural injections will be executed under ultrasound guidance 3 times (in 3 consecutive sessions): at their first assessment, 2 and 4 weeks later.

DRUGLidocaine

In the Lidocaine group (group L) the respective infusion of a solution of 8 ml of lidocaine 1% at the 4 genicular nerves (2ml per nerve) will be prepared as follows: 4 ml of lidocaine 2% with 4 ml of NaCl 0.9%. The perineural injections in each group will be executed 3 times (in 3 consecutive sessions): at their first assessment, 2 and 4 weeks later.