CompletedPhase 2

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

United States48 participantsStarted 2022-04-10

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Timeframe: Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

Trial details

NCT IDNCT05160532

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.