Effect of Prolotherapy in Knee Osteoarthritis.

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Prolotherapy with 25% Dextrose

• Registration Number: NCT04178304
• Lead Sponsor: University of Alexandria

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2019-12-15
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G1 patients receive prolotherapy	Prolotherapy with 25% Dextrose	Intra and extra articular dextrose 25%

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria University, Faculty of Medicine; 🇪🇬 Alexandria, Egypt