Effect of Prolotherapy in Knee Osteoarthritis.

Study Overview
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Brief Summary
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Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically . Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.

Detailed Description
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Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done. The intervention: a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .

Official Title
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Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Prolotherapy with 25% Dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III) consent obtained Exclusion Criteria: Early Knee osteoarthritis (KL grade I) Severe Knee osteoarthritis (KL grade IV) Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases. received oral or systemic steroids 1 year prior to the procedure received intra-articular steroids or hyaluronic acid 1 year prior to the procedure BMI >45Kg/m2 poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Interventional Model Description: Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1 patients receive prolotherapy<br>Intra and extra articular dextrose 25% | Drug: Prolotherapy with 25% Dextrose<br>* Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose<br>* Other names: 25% dextrose intra and extra-articilar injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Stiffness and Physical function | whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis | 24 weeks after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cartilage thickness | whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy | 24 weeks after last injection | 
| Safety and Tolerability | safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale | 24 weeks after last injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound