Effect of Prolotherapy in Knee Osteoarthritis.

University of Alexandria63 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Prolotherapy with 25% DextroseDRUG

Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Alexandria University, Faculty of Medicine

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: 24 weeks after last injection

Secondary Outcomes

Cartilage thickness

whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy

Time frame: 24 weeks after last injection

Safety and Tolerability

safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale

Time frame: 24 weeks after last injection

Data from ClinicalTrials.gov

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