Back to resultsChitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Knee Arthritis
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phonophoresis with chitosan
Phonophoresis with glucoasmine
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- El-Kasr El-Ainy hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A (Phonophoresis with chitosan group)
Group B (Phonophoresis with glucosamine group)
Group C (Conventional physical therapy only)
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05420441
Brief Title
Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis
Official Title
Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 ?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Phonophoresis with chitosan group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (Phonophoresis with glucosamine group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C (Conventional physical therapy only)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phonophoresis with chitosan
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Phonophoresis with glucoasmine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale
Description
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).
Time Frame
Baseline and Change from baseline pain scores at four weeks
Title
Change in WOMAC INDEX
Description
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.
Time Frame
Baseline and Change from baseline scores at four weeks
Title
Range of Motion at knee joint both in extension and flexion
Description
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
Time Frame
Baseline and Change from baseline scores at four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed H ElGendy, Ph.D
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
El-Kasr El-Ainy hospital
City
Al Manyal
State/Province
Cairo
ZIP/Postal Code
12611
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis
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