NCT07245121 Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
| NCT ID | NCT07245121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-11-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
✉ kkalimeris@med.uoa.gr📞 +302105831997
Konstantinos Kalimeris, Assoc Prof of Anesthesiology
STUDY CHAIR
National and Kapodistrian University of Athens
Frequently Asked Questions
Who can join the NCT07245121 clinical trial?
This trial is open to participants of all sexes, aged 38 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07245121 currently recruiting?
Yes, NCT07245121 is actively recruiting participants. Contact the research team at kkalimeris@med.uoa.gr for enrollment information.
Where is the NCT07245121 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07245121 clinical trial?
NCT07245121 is sponsored by National and Kapodistrian University of Athens. The principal investigator is Konstantinos Kalimeris, Assoc Prof of Anesthesiology at National and Kapodistrian University of Athens. The trial plans to enroll 60 participants.
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