Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT04178304
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2019-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prolotherapy in Knee Osteoarthritis.
Sponsor:
University of Alexandria
Organization:
Study Overview
Official Title:
Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 .
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: