Back to resultsUltrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
Primary Purpose
Osteo Arthritis Knee
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Therapeutic Ultrasonic
Hyaluronan intra-articular injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Risk of fall, osteoarthritis, hyaluronate, geriatric females
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.
Sites / Locations
- Faculty of Physical Therapy, Badr UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Injection group
Ultrasound group
Arm Description
Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
Group (2) served as the control group, will receive only HA intra-articular knee injection.
Outcomes
Primary Outcome Measures
ROM
Range of motion by using OB Goniometer "Myrin"
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06078449
Brief Title
Ultrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
Official Title
Effect of Ultrasound With Simultaneous Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2023 (Anticipated)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Risk of fall, osteoarthritis, hyaluronate, geriatric females
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injection group
Arm Type
Experimental
Arm Description
Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
Arm Title
Ultrasound group
Arm Type
Other
Arm Description
Group (2) served as the control group, will receive only HA intra-articular knee injection.
Intervention Type
Device
Intervention Name(s)
Therapeutic Ultrasonic
Intervention Description
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
Drug
Intervention Name(s)
Hyaluronan intra-articular injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
ROM
Description
Range of motion by using OB Goniometer "Myrin"
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.
Title
6 min walk test
Description
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.
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.
Title
Berg balance scale
Description
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.
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hend R Sakr, PhD
Phone
+201010151300
Email
hend.reda@buc.edu.eg
Facility Information:
Facility Name
Faculty of Physical Therapy, Badr University
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
11829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hend Sakr, PhD
Phone
01010151300
Email
hend.reda@buc.edu.eg
12. IPD Sharing Statement
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Ultrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
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