Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial.
National and Kapodistrian University of Athens
60 participants
Nov 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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.
Exclusion Criteria13
- 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
- History of acute lumbosacral radiculopathy or peripheral neuropathy, neurological, psychiatric disease
- Pain limited in the posterior aspect of the knee
- History of limb malignancy
- History of bleeding disorder
- Pregnancy
- Allergy to local anesthetics, needle phobia
- Difficulty communicating (severe hearing loss, dementia, language problems)
- Non-guaranteed transportation to hospital for treatments and re-evaluations
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Interventions
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.
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.
Locations(1)
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NCT07245121