Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Last updated: June 10, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

2

Condition

Knee Injuries

Osteoarthritis

Treatment

Placebo

Dextrose prolotherapy (DPT)

Clinical Study ID

NCT05160532
21-008778
  • Ages 40-80
  • All Genders

Study Summary

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of knee OA by clinical criteria (American College of Rheumatology).

  • Identification of knee osteoarthritis by a radiologist on an existing kneeradiograph obtained within 3 years of enrollment.

  • Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the averagelevel of your left/right knee pain in the past 3 months?".

Exclusion

Exclusion Criteria:

  • Pregnancy.

  • Diabetes.

  • Anticoagulation therapy.

  • History of total knee replacement.

  • Prior knee prolotherapy or other regenerative product.

  • Any knee injection within 3 months.

  • Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.

  • Daily use of opioid medication.

  • Allergy or intolerance to study medication, corn allergy.

  • Body mass index (BMI) greater than 40 kg/m^2.

  • Comorbidity severe enough to prevent participation in the study protocol.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 10, 2022
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85260
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.