Dextrose Injections for Knee Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Opioids

Disqualifiers: Pregnancy, Diabetes, Knee replacement, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of dextrose prolotherapy (a sugar solution injection) for treating knee osteoarthritis (OA) and to determine the optimal frequency of administration. Participants will receive various combinations of dextrose injections and placebos to identify the most effective regimen. The trial seeks individuals who have experienced moderate to severe knee pain from OA for at least three months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings in knee OA treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulation therapy or use opioid medication daily.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dextrose prolotherapy (DPT) is generally safe for treating knee osteoarthritis. Studies have found that it can reduce pain and improve joint function. In one study, patients who received DPT experienced steady improvement in pain and movement over time. Another study noted that DPT was well-tolerated, with no major safety issues reported.

Most people handle DPT well, with few side effects. Some might feel mild pain at the injection site, but this is not serious. Overall, DPT has demonstrated a good safety record, making it a promising option for managing knee osteoarthritis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about dextrose prolotherapy for knee osteoarthritis because it offers a potentially novel approach compared to standard treatments like NSAIDs, corticosteroid injections, or physical therapy. Unlike these options, dextrose prolotherapy involves injecting a sugar solution directly into the knee joint, which may stimulate the body's natural healing processes and promote tissue repair. This method could offer a longer-lasting solution to pain relief by targeting the root cause rather than just managing symptoms. Additionally, dextrose prolotherapy is considered minimally invasive and might reduce the need for surgery or long-term medication.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

This trial will evaluate the effectiveness of dextrose prolotherapy (DPT) for knee osteoarthritis. Studies have shown that dextrose prolotherapy can effectively reduce pain and stiffness in individuals with knee osteoarthritis. Research indicates that patients experience improved movement and joint function after receiving these injections. Clinical evidence suggests that dextrose prolotherapy often leads to better long-term results than traditional treatments. In some studies, patients reported significant and lasting relief from knee pain and improved knee function. This treatment shows promise for those dealing with knee osteoarthritis symptoms. Participants in this trial may receive varying numbers of DPT injections, while some will receive placebo injections for comparison. ^{3 4 5 6 7}

Who Is on the Research Team?

David Patchett, DO

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had knee pain of 4 or more on a scale of 0-10 for the last 3 months.

A radiologist found knee osteoarthritis on my X-ray taken in the last 3 years.

I have had knee pain of 4 or more on a scale of 0-10 for the last 3 months.

Exclusion Criteria

I have diabetes.

Body mass index (BMI) greater than 40 kg/m^2.

I use opioid medication every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraarticular knee injections under ultrasound guidance, with varying combinations of dextrose prolotherapy and placebo over four sessions

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using WOMAC and pain scales

36 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dextrose Prolotherapy
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Two injections of DPT and two injections of placebo Experimental Treatment 2 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 placebo Experimental Treatment 2 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 DPT Experimental Treatment 1 Intervention

Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).

Group IV: Four injections of placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3659139/

Dextrose Prolotherapy for Knee Osteoarthritis Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194473/

The effect of dextrose prolotherapy on patients diagnosed ... It is apparent that dextrose prolotherapy exhibits promising effectiveness in reducing joint pain and stiffness, as well as improving functional performance in ...

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1602727/full

Hypertonic dextrose prolotherapy in osteoarthritis Clinical evidence supports its effectiveness in reducing pain and enhancing mobility, often providing superior results compared to traditional ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08580-5

Comparison of the efficacy of ultrasound-guided dextrose 25 ... Dextrose prolotherapy (DPTx) has been shown to have a beneficial effect on knee OA in the long-term. In this randomized controlled trial (RCT), ...

5. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/2572

Efficacy of Prolotherapy for Osteoarthritis: A Systematic ... Results: 12 studies reported that DPT was as effective or even more effective in improving functional outcomes compared with other interventions ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35257594/

Effectiveness, Compliance, and Safety of Dextrose ... Dextrose prolotherapy yielded greater reductions in pain score over each follow-up duration than did the placebo. Compared with other invasive therapies, ...

7. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/33921-a-comprehensive-update-of-prolotherapy-in-the-management-of-osteoarthritis-of-the-knee

A Comprehensive Update of Prolotherapy in the ... Prolotherapy appears to be a safe treatment alternative that has been shown to improve stiffness, pain, function, and quality of life in osteoarthritis of the ...