Perineural prolotherapy for chronic knee osteoarthritis pain
Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial.
This trial will test whether adding 5% dextrose to perineural injections reduces pain in adults with chronic knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 38 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT07245121 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults older than 38 with symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2–3), persistent moderate–severe pain (NRS >5) for at least three months, and BMI up to 42 may be eligible.
Not a fit: Patients with very advanced osteoarthritis (KL grade 4), active knee infection, recent knee surgery, or lower pain levels are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding dextrose could provide greater and longer-lasting pain relief and improved knee function without destroying nerve tissue.
How similar studies have performed: Perineural prolotherapy is a relatively new approach with some initial positive reports suggesting benefit, but larger randomized trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Athens, Attica
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.