Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

Sponsor
October 6 University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05420441
Collaborator
(none)
60
1
3
5.2
11.5

Study Details

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 ?

Condition or Disease Intervention/Treatment Phase
  • Device: Phonophoresis with chitosan
  • Device: Phonophoresis with glucoasmine
  • Procedure: Conventional Physical Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
Actual Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 El-Kasr El-Ainy hospital Al Manyal Cairo Egypt 12611

Sponsors and Collaborators

  • October 6 University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University
ClinicalTrials.gov Identifier:
NCT05420441
Other Study ID Numbers:
  • ChPhono2022
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022