Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

June 12, 2022 updated by: Mohamed Magdy Ali Hassan ElMeligie, October 6 University

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

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 ?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Al Manyal, Cairo, Egypt, 12611
        • El-Kasr El-Ainy hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A (Phonophoresis with chitosan group)
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
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
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.
EXPERIMENTAL: Group B (Phonophoresis with glucosamine group)
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.
Device: 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.
ACTIVE_COMPARATOR: Group C (Conventional physical therapy only)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale
Time Frame: 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).
Baseline and Change from baseline pain scores at four weeks
Change in WOMAC INDEX
Time Frame: 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.
Baseline and Change from baseline scores at four weeks
Range of Motion at knee joint both in extension and flexion
Time Frame: 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
Baseline and Change from baseline scores at four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Study Chair: Mohamed H ElGendy, Ph.D, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (ACTUAL)

June 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChPhono2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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