Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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.
Sites / Locations
- Mayo Clinic in ArizonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
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
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.
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.
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.
Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).