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Completed

NCT Number: NCT04178304

Effect of Prolotherapy in Knee Osteoarthritis.

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

About this study

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:

  • a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.
  • 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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolotherapy with 25% Dextrose

Drug

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

Primary outcomes

  1. Pain, Stiffness and Physical function

    Time frame: 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 outcomes

  1. Cartilage thickness

    Time frame: 24 weeks after last injection

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

  2. Safety and Tolerability

    Time frame: 24 weeks after last injection

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

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2019
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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