Effect of Honey Phonophoresis on Knee Cartilage Thickness

February 19, 2024 updated by: Mohamed Moustafa Mohamed Ahmed, University of Jazan

Influence of Honey Phonophoresis on Cartilage Thickness in Patients With Knee Osteoarthritis

Osteoarthritis (OA) is a progressive chronic disease with the loss of articular cartilage. It is now well recognized that the progression of the disease involves erosion of the cartilage, osteochondral inflammatory damage, and bone distortion. Many recent medical procedures provide treatment through improving symptoms through tissue regeneration and restoring homeostasis to local cells. Unlike bone, articular cartilage is rather recalcitrant to regenerate. Honey is a natural material contain 200 distinct chemical compounds in honey including a wide range of phenolic compounds that have antioxidant, bacteriostatic, antimicrobial, and anti-inflammatory properties. Honey was found to increase the printability and chondrogenic potential of a naturally derived bioink are the main formulations used as hydrogel for Articular Cartilage (AC) regeneration due to their similarity to chondral tissue in terms of morphological and mechanical properties. Design: Double blinded, Randomized control trial. Methods: 50 osteoarthritic patients will be evaluated to be allocated after they match the inclusion criteria then randomized to two groups, group A for Phonophoresis using Honey as coupling media with conventional physical therapy program, group B for ultrasound with regular gel as a coupling media with conventional physical therapy. Outcome measures: the primary outcome measure will be the thickness of the cartilage will be measured using diagnostic ultrasound, the secondary outcome measure will be knee pain measured by the visual analog scale (VAS) and Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale, also functional mobility which will be measured using the stiffness and physical function subscales of the total WOMAC. All will be measured 1 day before starting the procedures and after 4 weeks of the intervention 3sessions/week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted on patients with bilateral medial tibiofemoral OA, Patients who will be diagnosed and referred by a physician according to the following criteria: bilateral mild-to-moderate medial tibiofemoral OA based on the American College of Rheumatology criteria, and a radiological image (Kellgren-Lawrence Grade II-III). All the patients will be informed about the study and consented to participate in it.

Patients will be excluded from the study if they have rheumatologic conditions such as rheumatoid arthritis, severe knee OA, thrombosis of the lower limbs, physiotherapy treatment of the knee in the previous 6 months, a history of injections in the knee joint during the last 6 months, balance disorders, neuropathy or sensory disorders, skin damage around the knee, previous surgery on the knee joint, or a previous fracture of the lower extremity with knee joint involvement. Patients will be also excluded if they have any contraindications or precautions for the use of ultrasound (e.g., infection, heart problems, pacemaker, metal implants, open epiphysis, pregnancy, thrombophlebitis, or impaired sensation).

Fifty patients with bilateral knee OA whose ages range from 40 to 65 years and body mass indexes between 25 to 35 kg/m2, who will meet the eligibility criteria and will be randomized into two treatment groups using computer-generated numbers in sealed envelopes. The patients will be blinded to the group allocation. Group A will receive phonophoresis with honey and conventional physical therapy treatment in the form of transcutaneous electrical nerve stimulation (TENS) current and exercise (study group). The parameters of the application of phonophoresis will be the continuous modality, 1 MHz frequency, intensity of 1 or 1.5 W/cm2, and an application time of 10 minutes. Group B will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group).

Evaluation procedure:

The evaluation process will be conducted within the Department of physical therapy, and Department of radiology of Jazan University, Jazan region, KSA.

The primary outcome measure will be the thickness of the cartilage will be measured using the Versana Essential ultrasound device made in USA using the flat probe 10Hz, the device will measure the cartilage thickness in the middle and posterior medial femoral regions.

The secondary outcome measure will be knee pain measured by the visual analog scale (VAS) and Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale.

The third outcome measure will be functional mobility which will be measured using the stiffness and physical function subscales of the total WOMAC.

Each patient will be assessed 1 day before starting the first session and after the last session according to the same criteria by an assessor who was blinded to the patient's allocation. Initially, all patients will be questioned about their personal data, including age, weight, height, onset and duration of knee pain, and any history of chronic diseases.

Treatment procedure:

The treatment will be conducted in the department of physical therapy, Jazan University, Jazan, KSA.

The total duration of treatment will be 4 weeks, and the treatments will be conducted on alternate days with a frequency of 3 sessions/week. The treatment will target the most affected and painful knee. For patients with equal pain in both knees, the dominant knee was treated. The other knee will take its conventional treatment as an ethical right for the patient to take his/her full treatment.

Both groups will receive the same exercise program during every session for strengthening the quadriceps muscle. The dose will be three sets of ten repetitions, with the starting weight being matched to the ten-repetition maximum weight of each participant. The following quadriceps exercises will be used: (1) quads over a roller (inner range knee extension) using ankle weights for resistance; (2) knee extension in sitting (sitting with the knee at 90° flexion and performing full extension using ankle weights for resistance); (3) straight leg raise (starting in the supine position and raising the leg to 30° hip flexion using ankle weights for resistance); and (4) outer range knee extension (sitting with the knee at 90° flexion and extending to 60° against the resistance of an elastic band). Patients will not be instructed to use any special footwear or insole during treatment to reduce variables and interactions as much as possible.

TENS will be applied to both groups at a frequency of 80 Hz for 20 min (using the Endomed 182 ENRAF NONIUS, Netherlands) through four adhesive electrodes placed over the medial side of the knee region with pulse width constant among all patients and an intensity in the tactile sensation threshold.Ultrasound will be applied to the medial tibiofemoral joint in a continuous mode at a frequency of 1 MHz and an intensity of 1 W/cm2 for a treatment duration of 10 min (Pulson 100 Gymna Uniphy, Belgium) using ultrasound gel for the control group and original honey as a medium under ultrasound head for study group (original honey will be collected from seasonal extracted honey within Jazan region at the time of starting the intervention) for the phonophoresis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • bilateral mild-to-moderate medial tibiofemoral Osteoarthritis

Exclusion Criteria:

  1. rheumatologic conditions such as:

    • rheumatoid arthritis,
    • severe knee OA,
    • thrombosis of the lower limbs,
  2. patients who had physiotherapy treatment of the knee in the previous 6 months,

  3. a history of injections in the knee joint during the last 6 months,

    • balance disorders,
    • neuropathy or sensory disorders,
    • skin damage around the knee,
    • previous surgery on the knee joint, or a previous fracture of the lower extremity with knee joint involvement.
  4. Patients will be also excluded if they have any contraindications or precautions for the use of ultrasound (e.g., infection, heart problems, pacemaker, metal implants, open epiphysis, pregnancy, thrombophlebitis, or impaired sensation)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Honey Group
will receive phonophoresis with honey and conventional physical therapy treatment in the form of transcutaneous electrical nerve stimulation (TENS) current and exercise . The parameters of the application of phonophoresis will be the continuous modality, 1 MHz frequency, intensity of 1 or 1.5 W/cm2, and an application time of 10 minutes
Device: Phonophoresis
Ultrasound using honey as a media over the knee joint
Procedure: conventional physiotherapy
TENS, Strengthening, and stretching exercises
Other: Control Group
will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group)
Procedure: conventional physiotherapy
TENS, Strengthening, and stretching exercises
Device: Ultrasound
ultrasound using gel as a media over the knee joint

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cartilage thickness
Time Frame: 4 weeks
knee joint cartilage thickness
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: 4 weeks
measurment of knee pain using Visual analogue scale which is a straight horizontal line of 100 mm. The ends are defined as the extreme limits of the pain orientated from the left (Best) to the right (Worst).
4 weeks
Functional mobility
Time Frame: 4 weeks
Using The Western Ontario and McMaster Universities Arthritis Index which is consisting from consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.
4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jazan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abdelrahman Elsayegh, Associate professor, Jazan 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-45/05/851

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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