Ultrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis

NCT ID: NCT06078449

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2024-03-30

Brief Summary

For many years' physiotherapists have been using ultrasound in treatment of knee osteoarthritis especially in geriatrics (people aged above 65 years) for its known therapeutic effect in relieving pain and improving knee function. Hyaluronan is used to treat osteoarthritis of the knee. Such treatments, called viscosupplementation, are administered as a course of injections into the knee joint, and are believed to supplement the viscosity of the joint fluid, thereby lubricating the joint, cushioning the joint, and producing an analgesic effect. Studies reveals the risk for falls increases with additional symptomatic OA lower limb joints and confirms in addition to gender factor; including female sex.

Detailed Description

It is hypothesized that physical therapy by ultrasound might add some extra benefit on risk of fall when applied after intra-articular hyaluronate of Knee OA in female geriatrics. So, forty female geriatrics with ages ranged from 65 to 75 years, randomly will be selected from Ahmed Maher Teaching Hospital, Kasr el einy hospital, Charity clinic and Outpatient clinic of Badr university, referred to physical therapy by an orthopedic surgeon. All will be diagnosed as chronic OA of one or both knees where conventional therapeutic measures failed. They will be assigned to begin HA intra-articular knee injection by the orthopedic surgeon once weekly for 3 weeks. These patients will be randomly divided into 2 groups equal in number, group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound, while group (2) served as the control group receiving only HA intra-articular knee injection.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Injection group

Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.

Group Type: EXPERIMENTAL

Therapeutic Ultrasonic

Intervention Type: DEVICE

Ultrasound is a therapeutic modality that has been used by physical therapists to achieve therapeutic benefits. It is alternating compression and rarefaction of sound waves with a frequency of \>20,000 cycles/second. Therapeutic ultrasound frequency will be used by 0.7 to 3.3 MHz. Maximum energy absorption in soft tissue will be 2 to 5 cm. Intensity decreases as the waves penetrate deeper. It is applied using a round headed wand or probe that is put in direct contact with the patient's skin. Ultrasound gel must be used on all surfaces of the head as a conducting medium in order to assist in the transmission of the ultrasonic waves \& to reduce friction.

Hyaluronan intra-articular injection

Intervention Type: DRUG

The type of Hyaluronan injection that will be used in this study consists of High Molecular Weight Hyaluronic acid (High MW HA 3000 kDa), will be given by the orthopedic surgeon.

Ultrasound group

Group (2) served as the control group, will receive only HA intra-articular knee injection.

Group Type: OTHER

Hyaluronan intra-articular injection

Intervention Type: DRUG

The type of Hyaluronan injection that will be used in this study consists of High Molecular Weight Hyaluronic acid (High MW HA 3000 kDa), will be given by the orthopedic surgeon.

Interventions

Therapeutic Ultrasonic

Ultrasound is a therapeutic modality that has been used by physical therapists to achieve therapeutic benefits. It is alternating compression and rarefaction of sound waves with a frequency of \>20,000 cycles/second. Therapeutic ultrasound frequency will be used by 0.7 to 3.3 MHz. Maximum energy absorption in soft tissue will be 2 to 5 cm. Intensity decreases as the waves penetrate deeper. It is applied using a round headed wand or probe that is put in direct contact with the patient's skin. Ultrasound gel must be used on all surfaces of the head as a conducting medium in order to assist in the transmission of the ultrasonic waves \& to reduce friction.

Intervention Type: DEVICE

Hyaluronan intra-articular injection

The type of Hyaluronan injection that will be used in this study consists of High Molecular Weight Hyaluronic acid (High MW HA 3000 kDa), will be given by the orthopedic surgeon.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients' ages above 65 years.
• Patients diagnosed as chronic osteoarthritis of more than 5 years.
• The OA diagnosed as grade (III to V)
• Patients failed with conventional treatment.
• All patients followed up with the same orthopedic surgeon, and they took the same type of HA intra-articular injection (HA of High MW 3000 kDa).
• All patients were medically stable and do not suffer from any other diseases which may affect the trial results.
• All patients were not treated with analgesics or any medication which may cause misleading results.
• None of the patients received intra-articular hyaluronic acid injection for 1 year or intra-articular corticosteroid injection within the last 3 months.
• All patients didn't take or oral glucosamine or chondroitin supplements or stopped these drugs 2-3 months before participating in this study.
• Every patient signed a consent form.

Exclusion Criteria

• Young individuals (their age is below 65 years old).
• Mild degree of OA (grade I & II).
• Patients who had undergone knee arthroscopy, or any knee surgery.
• Patients with OA secondary to trauma.
• Patients with metal implants.
• Patients with CNS dysfunction.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

Hend Reda Sakr

Lecturer of Physical Therapy for Woman's Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy, Badr University

Cairo, New Cairo, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hend R Sakr, PhD

Role: CONTACT

hend.reda@buc.edu.eg

+201010151300

Facility Contacts

Hend Sakr, PhD

Role: primary

hend.reda@buc.edu.eg

01010151300

Other Identifiers

Hend 5

Identifier Type: -

Identifier Source: org_study_id