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Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Study Purpose

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
  • - Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
  • - 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?".

Exclusion Criteria:

  • - Pregnancy.
  • - Diabetes.
  • - Anticoagulation therapy.
  • - History of total knee replacement.
  • - Prior knee prolotherapy or other regenerative product.
  • - Any knee injection within 3 months.
  • - Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
  • - Daily use of opioid medication.
  • - Allergy or intolerance to study medication, corn allergy.
  • - Body mass index (BMI) greater than 40 kg/m^2.
  • - Comorbidity severe enough to prevent participation in the study protocol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05160532
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David Patchett, DO
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis
Arms & Interventions

Arms

Placebo Comparator: Four injections of placebo

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.

Experimental: One injection of DPT and three injections of placebo

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.

Experimental: Two injections of DPT and two injections of placebo

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.

Experimental: Four injections of DPT

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

Interventions

Drug: - Placebo

5ml of normal saline (NS)

Drug: - Dextrose prolotherapy (DPT)

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85260

Site Contact

Hannah Henderson, MA

[email protected]

480-301-6091

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