Actively Recruiting
Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management
Led by Shin Kong Wu Ho-Su Memorial Hospital · Updated on 2026-04-24
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Knee osteoarthritis (OA) is a common and disabling joint condition, especially in older adults, causing pain and limited function. This research compares two types of prolotherapy injections using a sugar solution called dextrose to manage knee OA. The study aims to find out if targeting injections based on MRI-detected knee damage is more effective than standard intra-articular injections that go directly into the knee joint. Participants will be randomly assigned to one of two groups. One group receives ultrasound-guided injections of 5 ml 20% dextrose into the knee joint at weeks 0, 2, and 4, plus physical therapy three times weekly for 4 weeks. The other group undergoes MRI scans and detailed knee exams, then receives ultrasound-guided injections of 20% dextrose around MRI-identified lesion sites with varying needle sizes as needed, also at weeks 0, 2, and 4, along with the same physical therapy. During the study, participants will be assessed at baseline, 1.5, 3, and 6 months after treatment starts. Measures include the Western Ontario McMaster University Osteoarthritis Index (WOMAC) for pain and function, pain visual scales, quality of life surveys, and mobility tests. Researchers will monitor treatment effects and safety throughout. The total study duration for each participant spans at least 6 months to evaluate lasting benefits.
CONDITIONS
Brief Title
Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 to 80 years old
- Meet at least three of the six American College of Rheumatology criteria: age over 50, morning stiffness less than 30 minutes, crepitus during knee movement, bony tenderness, bony enlargement, no palpable warmth
- Radiologic grading of 2 or 3 by Kellgren-Lawrence criteria
- Willingness to receive prolotherapy
You will not qualify if you...
- Severe systemic disorders such as cancer, uncontrolled diabetes, sepsis, or cardiopulmonary diseases
- History of anticoagulation therapy or knee injection in the past three months
- History of knee surgery or planned knee replacement
- History of drug abuse
- Intolerance to prolotherapy
- Pregnancy
- Infectious arthritis, inflammatory joint diseases, or joint dysplasia
- Body Mass Index greater than 35 kg/m2
- Not suitable or unwilling to have an MRI of the knee examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive ultrasound-guided injections of 20% dextrose either intra-articularly or extra-articularly targeting MRI-positive lesion sites, along with physical therapy including heat, electric therapy, and therapeutic exercises three times a week for 4 weeks.
3 injection visits at weeks 0, 2, and 4; physical therapy three times a week during the first 4 weeks
Duration - Up to 6 months after treatment begins
Participants are monitored to assess changes in osteoarthritis symptoms and physical function after treatment.
Visits at 1.5 months, 3 months, and 6 months post-treatment start
Trial Site Locations
Total: 1 location
1
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
L
Lin-Fen Hsieh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here