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Completed
NCT05160532
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Conditions: Knee Osteoarthritis
Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 48
Sponsor: Mayo Clinic
Location: Mayo Clinic in Arizona Scottsdale Arizona
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 Criteria:
* Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
* Identification of knee osteoarthritis by a radiologist on an existing knee radiograph 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 average level of your left/right knee pain in the past 3 months?".
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.
* Use of oral steroids during the study period
* Use of injectable steroids in the past 3 months or during the study period
Source: ClinicalTrials.gov (NCT05160532). StuddyBuddy aggregates publicly available trial information.