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NCT05160532 | RECRUITING | Knee Osteoarthritis

Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

David C. Patchett, DO

Brief Summary:

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.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Placebo

Dextrose prolotherapy (DPT)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Actual Study Start Date : 2022-04-10
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Location Details

NCT05160532

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic in Arizona

Scottsdale, arizona, United States, 85260