Osteo Arthritis KneeNCT06078449
Ultrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
A study testing Therapeutic Ultrasonic and Hyaluronan intra-articular injection in people with Osteo Arthritis Knee, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women only
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Therapeutic Ultrasonic and Hyaluronan intra-articular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Badr University
Cairo, New Cairo, 11829
Hend Sakr, PhD, 01010151300, hend.reda@buc.edu.eg
About this study
Official title: 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.
Read the 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
- Being tested
- Therapeutic Ultrasonic, Hyaluronan intra-articular injection
- Keywords
- Risk of fall, osteoarthritis, hyaluronate, geriatric females
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic UltrasonicDevice
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 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Injection group | Experimental | Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound. Receives: 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. Receives: Drug: Hyaluronan intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
Range of motion by using OB Goniometer "Myrin"
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start11 Nov 2023 (estimated)
- Primary completion11 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Reda Sakr, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078449
- Sponsor's protocol ID
- Hend 5
- Status last verified
- Oct 2023
- First submitted
- 8 Feb 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound With Simultaneous Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06078449
- Acronym / sponsor ID
- Hend 5
- Conditions
- Osteo Arthritis Knee
- Keywords
- Risk of fall, osteoarthritis, hyaluronate, geriatric females
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 11 Nov 2023 (estimated)
- Primary completion
- 11 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection group | Experimental | Device: Therapeutic Ultrasonic, Drug: Hyaluronan intra-articular injectionGroup (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound. |
| Ultrasound group | Other | Drug: Hyaluronan intra-articular injectionGroup (2) served as the control group, will receive only HA intra-articular knee injection. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic UltrasonicUltrasound 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. | Device | Injection group |
| Hyaluronan intra-articular injectionThe 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. | Drug | Injection group, Ultrasound group |
Primary outcome
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"
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ultrasonic and Hyaluronan intra-articular injection in people with Osteo Arthritis Knee, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend R Sakr, PhD (+201010151300, hend.reda@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.