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

October 9, 2023 updated by: Hend Reda Sakr, Badr University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Locations

  • Egypt
    • New Cairo
      • Cairo, New Cairo, Egypt, 11829
        • Recruiting
        • Faculty of Physical Therapy, Badr University
        • Contact:

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection group
Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
Device: 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.
Drug: 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.
Other: Ultrasound group
Group (2) served as the control group, will receive only HA intra-articular knee injection.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM
Time Frame: 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"
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.
6 min walk test
Time Frame: 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.
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.
Berg balance scale
Time Frame: 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.
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.

Collaborators and Investigators

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

Sponsor

Badr 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 (Estimated)

November 11, 2023

Primary Completion (Estimated)

March 11, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hend 5

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.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on Therapeutic Ultrasonic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe