What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs, glucocorticoids, and prolotherapy, have various side effects. NSAIDs (e.g., naproxen, ibuprofen) can cause gastrointestinal issues, cardiovascular problems, and kidney damage. Glucocorticoids (e.g., prednisone) may lead to weight gain, osteoporosis, and increased infection risk. Prolotherapy, which involves injecting irritants like hypertonic dextrose to promote tissue repair and reduce pain, can cause temporary pain, swelling, and bruising at the injection site. While prolotherapy is generally considered safe, more research is needed to fully understand its long-term effects.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. Commonly approved medications include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, and corticosteroid injections such as triamcinolone acetonide. While hypertonic dextrose injection (prolotherapy) is being studied for its potential to promote tissue repair and reduce pain, it is not yet FDA-approved for osteoarthritis treatment. Other investigational treatments like platelet-rich plasma (PRP) injections are also under study but have not received FDA approval due to inconsistent evidence of efficacy.

What other types of research exist?

Promising, novel alternatives to hypertonic dextrose injection for osteoarthritis patients in 2024 include: 1) Intra-articular injections of AOD9604 with or without hyaluronic acid, which have shown potential in reducing OA symptoms in rabbit models. 2) Intra-articular hyaluronic acid injections, which have demonstrated efficacy in both rabbit and canine models. 3) Intra-articular bevacizumab injections, which have been evaluated for their effects on OA in rabbit models.

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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 studying a treatment for knee pain caused by osteoarthritis. The treatment involves injecting a sugar-water solution into the knee using ultrasound guidance. Researchers want to find out how often the injections should be given and how effective they are at reducing pain and inflammation. Prolotherapy is an injection therapy for chronic musculoskeletal pain.

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.

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.

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.

Select...

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:

Select...

I have had a total knee replacement.

Select...

I have had knee prolotherapy or similar treatments before.

Select...

I have inflammation or arthritis in my knee due to conditions like RA or gout.

Select...

I use opioid medication every day.

Select...

I have diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

0 / 8Eligibility criteria met

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.