Knee Osteoarthritis
Conditions
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.
Interventions
DRUGPlacebo
5ml of normal saline (NS)
25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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. * Use of oral steroids during the study period * Use of injectable steroids in the past 3 months or during the study period
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Patchett, DO
Mayo Clinic
Outcome results
None listed