Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160532
• Other study ID #: 21-008778
• Status: Recruiting
• Phase: Phase 2
• Start date: April 10, 2022
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Placebo
5ml of normal saline (NS)
• Dextrose prolotherapy (DPT)
25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome.	Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks
Secondary	Change in pain	Measured using a visual analogue scale with 0 = no pain and 10=worst pain.	Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks