Perineural prolotherapy for chronic knee osteoarthritis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized controlled trial compares perineural prolotherapy using 5% dextrose plus local anesthetic versus local anesthetic alone, delivered to four genicular nerve sites around the knee. Ultrasound guidance is used to place injections at the superomedial, superolateral, inferomedial, and recurrent peroneal genicular nerves. Adults over 38 with chronic knee osteoarthritis, moderate to severe pain (NRS >5), and Kellgren-Lawrence grade 2–3 disease are eligible and randomized into two arms. Outcomes focus on pain reduction and function over follow-up to see if adding dextrose provides greater and possibly longer-lasting analgesia than anesthetic alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients of both sexes
2. Age \>38 years
3. Body Mass Index (BMI) up to 42 kg/m2
4. 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
5. Chronic knee pain on the Numerical Rating Scale (NRS) \> 5 for at least 3 months prior to the study
6. Grade 2 or 3 osteoarthritis, according to the Kellgern-Lawrence classification
7. Pain, creaking, and stiffness in the knee joint that persists for at least three months prior to the study.

Exclusion Criteria:

1. Any infection of the skin of the knee joint, such as cellulitis, or periarticular or intraarticular infection during the last 3 months
2. Poorly controlled diabetes mellitus or connective tissue disease affecting the knee joint
3. History of previous total knee arthroplasty or other knee surgery.
4. History of periarticular or intraarticular injection of corticosteroids, local anesthetic, hyaluronic acid, platelet-rich plasma, radiofrequency, prolotherapy within the last trimester
5. History of knee injury or fracture within the last 3 months
6. History of acute lumbosacral radiculopathy or peripheral neuropathy, neurological, psychiatric disease
7. Pain limited in the posterior aspect of the knee
8. History of limb malignancy
9. History of bleeding disorder
10. Pregnancy
11. Allergy to local anesthetics, needle phobia
12. Difficulty communicating (severe hearing loss, dementia, language problems)
13. Non-guaranteed transportation to hospital for treatments and re-evaluations

Where it's running

• University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School
  Athens, Attica, Greece Recruiting

Study contacts

• Study coordinator: Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
• Email: kkalimeris@med.uoa.gr
• Phone: +302105831997

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.