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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks
Awards & highlights

Study 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.
Select...
I have been diagnosed with knee osteoarthritis.
Select...
I have had knee pain of 4 or more on a scale of 0-10 for the last 3 months.
Select...
A radiologist found knee osteoarthritis on my X-ray taken in the last 3 years.

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,624 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age restriction for participation in this trial extend beyond 55 years?

"This research is seeking study participants aged between 40 and 80 years."

Answered by AI

Has Dextrose prolotherapy (DPT) been greenlighted by the FDA?

"Due to the limited amount of evidence backing up its effectiveness, Dextrose Prolotherapy (DPT) was scored a 2 - indicating moderate safety profiles."

Answered by AI

How many participants are being included in the research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov asserts that this health-related study is actively recruiting volunteers; it was first announced April 10th 2022 and last updated 21 days later. A total of 160 participants are sought at one medical centre."

Answered by AI

Do I meet the criteria to partake in this medical research?

"To be eligible to take part in this study, potential participants must aged between 40 and 80 years old and have arthrosis-related knee pain that is moderate or severe (scored ≥ 4 on a 0–10 point numeric rating scale) for more than 3 months. A total of 160 volunteers are needed."

Answered by AI

Is there still an opportunity to join the study at this point in time?

"Referring to the details available on clinicaltrials.gov, it appears that this medical trial is open for enrollment with a commencement date of April 10th 2022 and has been recently updated as of April 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Arizona
How old are they?
65+
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Recent research and studies
clinicaltrials.govStudy
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
David C. Patchett, DO 2022. "Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05160532.
All > Knee Osteoarthritis
~53 spots leftby Apr 2025
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