NCT05420441

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 ?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 12, 2022

Last Update Submit

June 12, 2022

Conditions

Knee OsteoarthritisKnee Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Group A (Phonophoresis with chitosan group)

EXPERIMENTAL

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 chitosanProcedure: Conventional Physical Therapy

Group B (Phonophoresis with glucosamine group)

EXPERIMENTAL

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 glucoasmineProcedure: Conventional Physical Therapy

Group C (Conventional physical therapy only)

ACTIVE COMPARATOR

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

Interventions

Phonophoresis with chitosanDEVICE

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 A (Phonophoresis with chitosan group)
Phonophoresis with glucoasmineDEVICE

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 B (Phonophoresis with glucosamine group)
Conventional Physical TherapyPROCEDURE

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 A (Phonophoresis with chitosan group)Group B (Phonophoresis with glucosamine group)Group C (Conventional physical therapy only)

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • unilateral or bilateral grade II knee osteoarthritis (clinical and imaging diagnosis X-ray).
  • knee pain intensity ≥ 5 on the Visual Analogue Scale (VAS)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Kasr El-Ainy hospital

Al Manyal, Cairo Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Mohamed H ElGendy, Ph.D

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 15, 2022

Study Start

April 25, 2022

Primary Completion

September 30, 2022

Study Completion

October 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)