Effect of Prolotherapy in Knee Osteoarthritis.

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178304
• Other study ID #: 0201167
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Prolotherapy with 25% Dextrose
Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

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