An interventional study of Prolotherapy with 25% Dextrose in Knee Osteoarthritis, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment
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:
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.
Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
Also known as: 25% dextrose intra and extra-articilar injection
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Alexandria