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

Not Applicable

Recruiting

• Conditions: Osteo Arthritis Knee
• Interventions: Device: Therapeutic Ultrasonic; Drug: Hyaluronan intra-articular injection

• Registration Number: NCT06078449
• Lead Sponsor: Badr University

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.

Study Timeline

• Study First Submitted: 2023-02-08
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Study Start: 2023-11-11
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection group	Hyaluronan intra-articular injection	Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
Ultrasound group	Hyaluronan intra-articular injection	Group (2) served as the control group, will receive only HA intra-articular knee injection.
Injection group	Therapeutic Ultrasonic	Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.

Primary Outcome Measures

Name	Time	Method
Berg balance scale	At the beginning of study, we assess balance by Berg balance scale in patients in both groups then after one month to assess progression in balance in both groups.	The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
6 min walk test	At the beginning of study, we assess balance by 6 min walk test in patients in both groups then after one month to assess progression in balance in both groups.	The 6MWT required a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measured the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
ROM	At the beginning of study, we measure range of motion in patients in both groups then after one month to assess progression of range of motion in both groups.	Range of motion by using OB Goniometer "Myrin"

Trial Locations

Locations (1)

Faculty of Physical Therapy, Badr University; 🇪🇬 Cairo, New Cairo, Egypt