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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Patchett, DO

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+