Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

NCT ID: NCT05420441

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Knee Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Phonophoresis with chitosan

Intervention Type DEVICE

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

Conventional Physical Therapy

Intervention Type PROCEDURE

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)

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 Type EXPERIMENTAL

Phonophoresis with glucoasmine

Intervention Type DEVICE

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.

Conventional Physical Therapy

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

October 6 University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed H ElGendy, Ph.D

Role: STUDY_CHAIR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

El-Kasr El-Ainy hospital

Al Manyal, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChPhono2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.