Knee OsteoarthritisNCT05420441
Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis
A study testing Phonophoresis with chitosan, Phonophoresis with glucoasmine and Conventional Physical Therapy in people with Knee Osteoarthritis and Knee Arthritis, run by October 6 University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis
- What is being tested?
- Phonophoresis with chitosan, Phonophoresis with glucoasmine and Conventional Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unilateral or bilateral grade II knee osteoarthritis (clinical and imaging diagnosis X-ray).
- knee pain intensity ≥ 5 on the Visual Analogue Scale (VAS)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 ?
- Conditions
- Knee Osteoarthritis, Knee Arthritis
- Being tested
- Phonophoresis with chitosan, Phonophoresis with glucoasmine, Conventional Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
Conventional Physical TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Phonophoresis with chitosan; Procedure: 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. Receives: Device: Phonophoresis with glucoasmine; Procedure: 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. Receives: Procedure: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: Baseline and Change from baseline scores at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start25 Apr 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
- Investigators
- Mohamed H ElGendy, Ph.D, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420441
- Sponsor's protocol ID
- ChPhono2022
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05420441
- Acronym / sponsor ID
- ChPhono2022
- Conditions
- Knee Osteoarthritis, Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Phonophoresis with chitosan group) | Experimental | Device: Phonophoresis with chitosan, Procedure: Conventional Physical TherapyPatients 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 B (Phonophoresis with glucosamine group) | Experimental | Device: Phonophoresis with glucoasmine, Procedure: Conventional Physical TherapyPatients 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 C (Conventional physical therapy only) | Active comparator | Procedure: Conventional Physical TherapyPatients 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- unilateral or bilateral grade II knee osteoarthritis (clinical and imaging diagnosis X-ray).
- knee pain intensity ≥ 5 on the Visual Analogue Scale (VAS)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phonophoresis with chitosanPatients 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 | Group A (Phonophoresis with chitosan group) |
| Phonophoresis with glucoasminePatients 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 | Group B (Phonophoresis with glucosamine group) |
| Conventional Physical TherapyPatients 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 or surgery | Group A (Phonophoresis with chitosan group), Group B (Phonophoresis with glucosamine group), Group C (Conventional physical therapy only) |
Primary outcome
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).
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed H ElGendy, Ph.D study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonophoresis with chitosan, Phonophoresis with glucoasmine and Conventional Physical Therapy in people with Knee Osteoarthritis and Knee Arthritis, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (time frame: Baseline and Change from baseline pain scores at four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.