Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05420441
• Other study ID #: ChPhono2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2022
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted to answer the following questions:

• Is there an effect of phonophoresis using glucosamine on pain level , function and range of motion in knee osteoarthritis patients ?

• Is there an effect of phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?

• Is there a difference between the effect of phonophoresis using glucosamine and phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• unilateral or bilateral grade II knee osteoarthritis (clinical and imaging diagnosis X-ray).

• knee pain intensity = 5 on the Visual Analogue Scale (VAS)

Exclusion Criteria:

• Anterior Cruciate Ligament (ACL) and meniscus injury

• use of oral or injected corticosteroids in the last 3 months

• history of knee surgery or fracture

• acute infectious synovitis or arthritis conditions

• presence of malignancy

• individuals with, topical lesions, contact dermatitis and history of cutaneous hypersensitivity

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Phonophoresis with chitosan
Patients in this group will receive chitosan through phonophoresis plus conventional treatment. For the phonophoresis parameters: pulsed ultrasonic waves (25%) of 1 MHz frequency and 1 W/cm2 intensity applied with a 5 cm diameter transducer. The total time of ultrasound application was eight minutes.Patients will also receive conventional Physical therapy program
• Phonophoresis with glucoasmine
Patients in this group will receive glucosamine through phonophoresis plus conventional treatment. For the phonophoresis parameters: pulsed ultrasonic waves (25%) of 1 MHz frequency and 1 W/cm2 intensity applied with a 5 cm diameter transducer. The total time of ultrasound application was eight minutes.Patients will also receive conventional Physical therapy program.

Procedure:
• Conventional Physical Therapy
Patients in the control group will receive the conventional treatment for knee osteoarthritis only, which will include the application of TENS, pulsed ultrasound, infrared light and exercise.

Locations

Country	Name	City	State
Egypt	El-Kasr El-Ainy hospital	Al Manyal	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale	The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).	Baseline and Change from baseline pain scores at four weeks
Primary	Change in WOMAC INDEX	The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.	Baseline and Change from baseline scores at four weeks
Primary	Range of Motion at knee joint both in extension and flexion	The ROM will be measured using the Baseline 12-1056 bubble inclinometer. Patients will be in prone position and will be instructed to move their leg away from the thigh to measure extension range of motion and move the leg toward the thigh to measure flexion	Baseline and Change from baseline scores at four weeks