Clinical trial NCT04178304: Effect of Prolotherapy in Knee Osteoarthritis.
Official title: Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: primary knee osteoarthritis,
prolotherapy,
musculoskeletal ultrasound
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Pain, Stiffness and Physical function
timeFrame: 24 weeks after last injection
Secondary outcomes:
measure: Cartilage thickness
timeFrame: 24 weeks after last injection
measure: Safety and Tolerability
timeFrame: 24 weeks after last injection
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
affiliation: Alexandria University Faculty of Medicine
name: Yousra H Abdel-Fattah, MD
role: PRINCIPAL_INVESTIGATOR
References: