Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

Mayo Clinic48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

PlaceboDRUG

5ml of normal saline (NS)

Dextrose prolotherapy (DPT)DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

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 0-96, with higher scores indicating worse outcome.

Time frame: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52

Secondary Outcomes

Change in Pain

Measured using a visual analogue scale with 0 = no pain and 10=worst pain with higher scores indicating worse pain.

Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function in individuals with knee OA. Total scores range from 0-68, with higher scores indicating worse physical function.

Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure stiffness in individuals with knee OA. Total scores range from 0-8, with higher scores indicating worse stiffness.

Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure pain in individuals with knee OA. Total scores range from 0-20, with higher scores indicating worse pain.

Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52

Data from ClinicalTrials.gov

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