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

NCT06078449 | Unknown

• 1 other identifier: Hend 5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Risk of fall; osteoarthritis; hyaluronate; geriatric females

Outcome Measures

Primary Outcomes (3)

• ROM

  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

  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

  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.

Study Arms (2)

Injection group

EXPERIMENTAL

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

Device: Therapeutic Ultrasonic; Drug: Hyaluronan intra-articular injection

Ultrasound group

OTHER

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

Drug: Hyaluronan intra-articular injection

Interventions

Therapeutic Ultrasonic 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.

Injection group

Hyaluronan intra-articular injection 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.

Injection group; Ultrasound group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Gender Eligibility Details: Females are affected more than males due to menopausal changes and declined estrogen hormone that accelerates bone loss and leads to high risk of fall and decreased balance due to orthopedic issues.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Faculty of Physical Therapy, Badr University

Cairo, New Cairo, 11829, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Central Study Contacts

Hend R Sakr, PhD

CONTACT

+201010151300; hend.reda@buc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Woman's Health

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: October 11, 2023
• Study Start: November 11, 2023
• Primary Completion: March 11, 2024
• Study Completion: March 30, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

EG (1)