Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

Study Overview
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Brief Summary
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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 ?

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

Conditions
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Knee Osteoarthritis, Knee Arthritis

Intervention / Treatment
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* Device: Phonophoresis with chitosan
* Device: Phonophoresis with glucoasmine
* Procedure: Conventional Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Phonophoresis with chitosan group)<br>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 | Device: Phonophoresis with chitosan<br>* 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<br>Procedure: Conventional Physical Therapy<br>* 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.<br>|
| Experimental: Group B (Phonophoresis with glucosamine group)<br>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. | Device: Phonophoresis with glucoasmine<br>* 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.<br>Procedure: Conventional Physical Therapy<br>* 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.<br>|
| Active Comparator: Group C (Conventional physical therapy only)<br>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. | Procedure: Conventional Physical Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |