Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Placebo
* Drug: Dextrose prolotherapy (DPT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Four injections of placebo<br>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. | Drug: Placebo<br>* 5ml of normal saline (NS)<br>|
| Experimental: One injection of DPT and three injections of placebo<br>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. | Drug: Placebo<br>* 5ml of normal saline (NS)<br>Drug: Dextrose prolotherapy (DPT)<br>* 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.<br>|
| Experimental: Two injections of DPT and two injections of placebo<br>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. | Drug: Placebo<br>* 5ml of normal saline (NS)<br>Drug: Dextrose prolotherapy (DPT)<br>* 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.<br>|
| Experimental: Four injections of DPT<br>Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT). | Drug: Dextrose prolotherapy (DPT)<br>* 25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome. | Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Measured using a visual analogue scale with 0 = no pain and 10=worst pain. | Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks |