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

NCT07245121 NA RECRUITING

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.

Details

Lead sponsor	National and Kapodistrian University of Athens
Phase	NA
Status	RECRUITING
Enrolment	60
Start date	2025-11-24
Completion	2027-02

Conditions

• Chronic Pain
• Perineural Analgesia
• Prolotherapy
• Knee Osteoarthritis

Interventions

• Dextrose 5% and Lidocaine
• Lidocaine

Primary outcomes

• Pain Severity Score (PSS) at 15 days after the 3rd (last) infiltration — 15 days after the 3rd infiltration of the first participant up to 15 days after the 3rd infiltration of the last participant
  The primary outcome will be estimated by the Brief Pain Inventory (BPI) score, a numerical scale used to assess pain. This score is the arithmetic average of four items related to pain intensity: worst pain, least pain, average pain, and current pain (SCORE RANGE: 0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-10= Severe pain).

Countries

Greece