Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

Not Applicable

• Conditions: Knee Arthritis; Knee Osteoarthritis
• Interventions: Device: Phonophoresis with chitosan; Device: Phonophoresis with glucoasmine; Procedure: Conventional Physical Therapy

• Registration Number: NCT05420441
• Lead Sponsor: October 6 University

Brief 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 ?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Phonophoresis with chitosan group)	Conventional Physical Therapy	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
Group A (Phonophoresis with chitosan group)	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
Group B (Phonophoresis with glucosamine group)	Conventional Physical Therapy	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.
Group C (Conventional physical therapy only)	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.
Group B (Phonophoresis with glucosamine group)	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.

Primary Outcome Measures

Name	Time	Method
Range of Motion at knee joint both in extension and flexion	Baseline and Change from baseline scores at four weeks	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
Change in Visual Analog Scale	Baseline and Change from baseline pain scores at four weeks	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).
Change in WOMAC INDEX	Baseline and Change from baseline scores at four weeks	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.

Trial Locations

Locations (1)

El-Kasr El-Ainy hospital; 🇪🇬 Al Manyal, Cairo, Egypt