Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Last updated: October 15, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

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: 160
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

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