Actively Recruiting

Phase Not Applicable
Age: 38Years +
All Genders
NCT07245121

Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.

Led by National and Kapodistrian University of Athens · Updated on 2025-12-02

60

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.

Who Can Participate

Age: 38Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes
  • Age greater than 38 years
  • Body Mass Index (BMI) up to 42 kg/m2
  • Diagnosis of knee osteoarthritis by American College of Rheumatology clinical criteria
  • Chronic knee pain with Numerical Rating Scale (NRS) above 5 for at least 3 months
  • Grade 2 or 3 osteoarthritis by Kellgren-Lawrence classification
  • Pain, creaking, and stiffness in the knee lasting at least 3 months prior to study
Not Eligible

You will not qualify if you...

  • Skin infection or periarticular/intraarticular knee infection in last 3 months
  • Poorly controlled diabetes or connective tissue disease affecting the knee
  • Previous total knee arthroplasty or other knee surgery
  • Knee injections with corticosteroids, local anesthetic, hyaluronic acid, platelet-rich plasma, radiofrequency, or prolotherapy in last 3 months
  • Knee injury or fracture in last 3 months
  • Acute lumbosacral radiculopathy, peripheral neuropathy, neurological or psychiatric disease
  • Pain limited to the back of the knee only
  • History of limb malignancy
  • History of bleeding disorder
  • Pregnancy
  • Allergy to local anesthetics or needle phobia
  • Severe hearing loss, dementia, or language difficulties affecting communication
  • Lack of reliable transportation for treatments and follow-ups

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School

Athens, Attica, Greece, 124 62

Actively Recruiting

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Research Team

K

Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor

CONTACT

V

Vasileios Boviatsis MD, Msc, PhD candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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