Effect of Prolotherapy in Knee Osteoarthritis.

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Prolotherapy with 25% Dextrose

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 00123
    • Alexandria University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Yousra H Abdel-Fattah, MD, Alexandria University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: musculoskeletal ultrasound; primary knee osteoarthritis,; prolotherapy,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 0201167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No