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Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.

NCT07245121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dextrose 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.

DRUG

Lidocaine

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.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Konstantinos Kalimeris, Assoc Prof of Anesthesiology · National and Kapodistrian University of Athens

  • Theodosios Saranteas, Professor of Anesthesiology · National and Kapodistrian University of Athens

  • Andreas Maurogenis, Assoc Prof of Anesthesiology · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
38 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245121 on ClinicalTrials.gov