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Dextrose Injections for Knee Osteoarthritis

Phase 2
Recruiting
Led By David Patchett, DO
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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?".
Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
Must not have
History of total knee replacement.
Prior knee prolotherapy or other regenerative product.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks
Awards & highlights

Summary

This trial is testing whether an ultrasound-guided dextrose injection can improve symptoms of knee OA when done every 6 weeks, and whether it is more effective than doing the injection every 3 weeks.

Who is the study for?
This trial is for adults with knee osteoarthritis confirmed by a radiologist, experiencing moderate to severe pain for at least 3 months. They must not be pregnant, have a BMI over 40, use opioids daily, had recent knee injections or surgery, have allergies to the study medication or corn, severe comorbidities that prevent participation in the study protocol, diabetes, inflammatory arthritis like RA or gout, and can't be on anticoagulation therapy.Check my eligibility
What is being tested?
The trial is testing ultrasound-guided hypertonic dextrose injections (DPT) against placebo for treating symptomatic knee osteoarthritis. It aims to find out how often these injections should be given and how effective they are compared to no active treatment.See study design
What are the potential side effects?
Potential side effects of DPT may include pain at the injection site, swelling or stiffness in the knee joint following treatment. There could also be allergic reactions if there's an intolerance to any component of the injected solution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had knee pain of 4 or more on a scale of 0-10 for the last 3 months.
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I have been diagnosed with knee osteoarthritis.
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I have had knee pain of 4 or more on a scale of 0-10 for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a total knee replacement.
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I have had knee prolotherapy or similar treatments before.
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I have inflammation or arthritis in my knee due to conditions like RA or gout.
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I use opioid medication every day.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Secondary outcome measures
Change in pain

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Two injections of DPT and two injections of placeboExperimental Treatment2 Interventions
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.
Group II: One injection of DPT and three injections of placeboExperimental Treatment2 Interventions
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.
Group III: Four injections of DPTExperimental Treatment1 Intervention
Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
Group IV: Four injections of placeboPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoid injections, and hypertonic dextrose injections (prolotherapy). NSAIDs work by reducing inflammation and pain through the inhibition of cyclooxygenase enzymes. Glucocorticoid injections provide short-term pain relief by reducing local inflammation. Hypertonic dextrose injections, or prolotherapy, promote tissue repair and reduce pain by inducing a mild inflammatory response that stimulates the healing of damaged tissues. Understanding these mechanisms is crucial for OA patients as it helps them make informed decisions about their treatment options, balancing efficacy, potential side effects, and long-term outcomes.
Identification of early response to hypertonic dextrose prolotherapy markers in knee osteoarthritis patients by an inflammation-related cytokine array.The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study.Qualitative Assessment of Patients Receiving Prolotherapy for Knee Osteoarthritis in a Multimethod Study.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,246 Total Patients Enrolled
28 Trials studying Osteoarthritis
2,690 Patients Enrolled for Osteoarthritis
David Patchett, DOPrincipal InvestigatorMayo Clinic

Media Library

Dextrose Prolotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05160532 — Phase 2
Osteoarthritis Research Study Groups: Four injections of placebo, One injection of DPT and three injections of placebo, Two injections of DPT and two injections of placebo, Four injections of DPT
Osteoarthritis Clinical Trial 2023: Dextrose Prolotherapy Highlights & Side Effects. Trial Name: NCT05160532 — Phase 2
Dextrose Prolotherapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160532 — Phase 2
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