Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Dextrose prolotherapy (DPT)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Four injections of placebo; Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.	Drug: Placebo; 5ml of normal saline (NS)
Experimental: One injection of DPT and three injections of placebo; Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.	Drug: Placebo; 5ml of normal saline (NS); Drug: Dextrose prolotherapy (DPT); 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.
Experimental: Two injections of DPT and two injections of placebo; Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.	Drug: Placebo; 5ml of normal saline (NS); Drug: Dextrose prolotherapy (DPT); 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.
Experimental: Four injections of DPT; Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).	Drug: Dextrose prolotherapy (DPT); 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David Patchett, DO, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 21-008778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No