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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 38
Healthy Volunteers: f
View:

• 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:

• A, B, C, D or A, B, E or A, D, E:

• A) Knee pain most days of the previous month B) Cracking during active joint movement C) Morning stiffness lasting at least 30 minutes D) Age at least 38 years E) Bone swelling of the affected knee on physical examination

• 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.

Locations
Other Locations
Greece
University General Hospital of Athens Attikon - National and Kapodistrian University of Athens Medical School
RECRUITING
Athens
Contact Information
Primary
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
kkalimeris@med.uoa.gr
+302105831997
Backup
Vasileios Boviatsis MD, Msc, PhD candidate
billboviatsis@gmail.com
+306982925945
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-02
Participants
Target number of participants: 60
Treatments
Active_comparator: Dextrose + Lidocaine group (group D+L)
In the Dextrose + Lidocaine group (group D+L) an ultrasound guided perineural injection of DW 5% and lidocaine 1% will be performed at the 4 genicular nerves (superomedial, superolateral, inferomedial, recurrent peroneal genicular nerve).
Active_comparator: Lidocaine group (group L)
In the lidocaine group (group L) an ultrasound guided perineural injection of a solution of lidocaine 1% will be performed at the 4 genicular nerves (superomedial, superolateral, inferomedial, recurrent peroneal genicular nerve).
Related Therapeutic Areas
Sponsors
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov