Effect of Honey Phonophoresis on Knee Cartilage Thickness

NCT06202092 | Recruiting

• 1 other identifier: REC-45/05/851
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• cartilage thickness

  knee joint cartilage thickness

  4 weeks

Secondary Outcomes (2)

• Pain severity

  4 weeks

• Functional mobility

  4 weeks

Study Arms (2)

Honey Group

EXPERIMENTAL

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; Procedure: conventional physiotherapy

Control Group

OTHER

will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group)

Device: Ultrasound; Procedure: conventional physiotherapy

Interventions

Phonophoresis DEVICE

Ultrasound using honey as a media over the knee joint

Honey Group

Ultrasound DEVICE

ultrasound using gel as a media over the knee joint

Control Group

conventional physiotherapy PROCEDURE

TENS, Strengthening, and stretching exercises

Control Group; Honey Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral mild-to-moderate medial tibiofemoral Osteoarthritis

You may not qualify if:

• rheumatologic conditions such as:
• rheumatoid arthritis,
• severe knee OA,
• thrombosis of the lower limbs,
• patients who had 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)

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (2)

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

RECRUITING

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Phonophoresis; Ultrasonography

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Abdelrahman Elsayegh, Associate professor

  University of Jazan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Ahmed, Assistant Professor

CONTACT

+966562819650; mmahmed@jazanu.edu.sa

Azza A Alareefy, Assistant Professor

CONTACT

+966506626062; aalareefy@jazanu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: January 15, 2024
• Primary Completion: February 15, 2024
• Study Completion: March 15, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)