Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Key facts
- Who runs it
- Mayo Clinic
- Where
- Scottsdale, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 48 people enrolled
- Started
- 10 Apr 2022
- Ended
- 31 May 2025
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Dextrose prolotherapy (DPT)
- Record updated
- 30 June 2026
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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?"
Who cannot take part
- Anticoagulation therapy
- Prior knee prolotherapy or other regenerative product
- Daily use of opioid medication
- Use of oral steroids during the study period
- Use of injectable steroids in the past 3 months or during the study period
- Diabetes
- History of total knee replacement
- Allergy or intolerance to study medication, corn allergy
- Pregnancy
- Any knee injection within 3 months
- Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis
- Body mass index (BMI) greater than 40 kg/m\^2
- Comorbidity severe enough to prevent participation in the study protocol
Where in United States
- Mayo Clinic in ArizonaScottsdale, United States
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Four injections of placeboPlacebo, for comparison
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.
Treatment: Placebo
- One injection of DPT and three injections of placeboTreatment being tested
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.
Treatment: Placebo and Dextrose prolotherapy (DPT)
- Two injections of DPT and two injections of placeboTreatment being tested
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.
Treatment: Placebo and Dextrose prolotherapy (DPT)
- Four injections of DPTTreatment being tested
Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
Treatment: Dextrose prolotherapy (DPT)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 June 2026