Effect of Prolotherapy in Knee Osteoarthritis.

University of Alexandria

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Drug: Prolotherapy with 25% Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04178304

0201167

Details and patient eligibility

About

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.

Full description

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:

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 ultrasonographically .

Enrollment: 63 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

G1 patients receive prolotherapy

Experimental group

Description:

Intra and extra articular dextrose 25%

Treatment:

Drug: Prolotherapy with 25% Dextrose