Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.

Recruiting now · Not applicable

Conditions studied: Chronic Pain, Perineural Analgesia, Prolotherapy, Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT07245121

Run by

National and Kapodistrian University of Athens

People needed

60

Starts

2025-11-24

Expected to finish

2027-02-01

Last updated by the study team

2025-12-02

Who can join

Age: 38 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School — Athens, Attica, Greece (enrolling)

Full record on ClinicalTrials.gov

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