Effect of Prolotherapy in Knee Osteoarthritis.

NCT04178304 | Completed

• 1 other identifier: 0201167
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

primary knee osteoarthritis,; prolotherapy,; musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks after last injection

Secondary Outcomes (2)

• Cartilage thickness

  24 weeks after last injection

• Safety and Tolerability

  24 weeks after last injection

Study Arms (1)

G1 patients receive prolotherapy

EXPERIMENTAL

Intra and extra articular dextrose 25%

Drug: Prolotherapy with 25% Dextrose

Interventions

Prolotherapy with 25% Dextrose DRUG

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

G1 patients receive prolotherapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
• consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Prolotherapy; Glucose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Yousra H Abdel-Fattah, MD

  Alexandria University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Medicine, Rheumatology and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: December 15, 2019
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)