Knee Osteoarthritis
Conditions
Keywords
primary knee osteoarthritis,, prolotherapy,, musculoskeletal ultrasound
Brief 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.
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 .
Interventions
Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose
Sponsors
University of Alexandria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.
Intervention model description
Sixty knees 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: 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 ultrasounographicly.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Stiffness and Physical function | 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
| Measure | Time frame | Description |
|---|---|---|
| Cartilage thickness | 24 weeks after last injection | whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy |
| Safety and Tolerability | 24 weeks after last injection | safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale |
Countries
Egypt
Outcome results
None listed