- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323030
THERAPEUTIC ULTRASOUND IN PATIENTS WITH KNEE OSTEOARTHRITIS
COMPARISON OF TWO DIFFERENT THERAPEUTIC ULTRASOUND TECHNIQUES IN COMBINATION WITH STANDARD PHYSICAL THERAPY VERSUS STANDARD PHYSICAL THERAPY ALONE IN PATIENTS WITH KNEE OSTEOARTHRITIS
Knee osteoarthritis is a common condition that causes pain, stiffness, and reduced physical function. Therapeutic ultrasound is frequently used in physical medicine and rehabilitation to reduce pain and improve joint function in patients with knee osteoarthritis; however, different ultrasound application techniques are used in clinical practice.
The aim of this study was to compare the effectiveness of two different therapeutic ultrasound techniques in patients with knee osteoarthritis. Participants with knee osteoarthritis received therapeutic ultrasound treatment using one of two application techniques according to a predefined treatment protocol. Clinical outcomes related to pain and functional status were evaluated before and after treatment.
This completed study provides information on whether different ultrasound application techniques lead to differences in clinical outcomes in patients with knee osteoarthritis and may help guide clinical decision-making in rehabilitation practice.
Study Overview
Status
Conditions
Detailed Description
This study was designed as a prospective, parallel-group interventional study to evaluate the clinical effectiveness of different therapeutic ultrasound application techniques in patients diagnosed with knee osteoarthritis.
Eligible participants with knee osteoarthritis were allocated into treatment groups according to the predefined study protocol. Therapeutic ultrasound was applied using two different techniques under standardized treatment parameters. All participants received treatment sessions over a defined treatment period.
Clinical outcome measures related to pain intensity and functional status were assessed at baseline and after completion of the treatment protocol. Outcome assessments were performed by an evaluator blinded to group allocation.
The primary objective of the study was to compare the effects of different therapeutic ultrasound techniques on pain reduction and functional improvement in patients with knee osteoarthritis. Secondary objectives included evaluating changes in physical function following treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Prof .Dr .Cemil Taşcioğlu City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age between 40 and 75 years,Clınıcal and radıografıc dıagnosısı of knee osteoartrıtsı accordıng to Amerıcan College of Rheumatology crıteria,Kellegren Lawrencw grade 2-3 osteoartritis,prencense of knee pain for at least 3 months,ability to ambulate independently, ability to understand and comply with study procedures
Exclusion Criteria:
- History of knee surgery or ıntraartıkuler ınjection within the 6 last month,severe knee osteoaertırtıcs (kellegren lawrence grade 4),Neurological disorders affecting lower exremity functıon ,pulmoner or systemic disease limitin participitian,pregnancy,current partpiciant ın another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: continius ultrasound group
hot pack,tens,exercise terapy ,continius ultasound
|
superficial heat therapy applied to the knee joınt using hot packs before other pyhsical terapy modalites .Hot packs are applied for approximately 15-20 minutes per session
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Exercise therapy is a structured, planned, and repetitive physical intervention designed to improve or maintain physical function, mobility, strength, balance, and overall health through targeted therapeutic exercises.
Continuous ultrasound is a therapeutic modality in which high-frequency sound waves are delivered continuously to biological tissues to produce predominantly thermal effects, leading to increased tissue temperature, enhanced blood flow, improved tissue extensibility, and pain modulation.
|
|
Experimental: pulse ultrasound group
hot pack,tens,exercise terapy,pulsed ultrasound
|
superficial heat therapy applied to the knee joınt using hot packs before other pyhsical terapy modalites .Hot packs are applied for approximately 15-20 minutes per session
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Exercise therapy is a structured, planned, and repetitive physical intervention designed to improve or maintain physical function, mobility, strength, balance, and overall health through targeted therapeutic exercises.
Pulsed ultrasound is a therapeutic ultrasound modality in which acoustic energy is delivered intermittently rather than continuously, resulting in predominantly non-thermal mechanical effects such as cavitation and acoustic microstreaming that promote tissue healing and reduce inflammation.
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|
Experimental: control group
hot pack,tens,exercise terapy
|
superficial heat therapy applied to the knee joınt using hot packs before other pyhsical terapy modalites .Hot packs are applied for approximately 15-20 minutes per session
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Exercise therapy is a structured, planned, and repetitive physical intervention designed to improve or maintain physical function, mobility, strength, balance, and overall health through targeted therapeutic exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity assessed by visuel analog scale (VAS)
Time Frame: baseline,immediately after treatment, and 2 months post-tratment
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Pain intensity was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Participants marked their perceived knee pain level at each assessment point.
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baseline,immediately after treatment, and 2 months post-tratment
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knee joint stiffness assessed by WOMAC stiffness subscale
Time Frame: baseline,immediately after treatment and at 2 months post treatment
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Knee joint stiffness was evaluated using the stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate greater stiffness and symptom severity.
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baseline,immediately after treatment and at 2 months post treatment
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lesquesne algofunctional ındex score
Time Frame: baseline,immediately after treatment,and at 2 months post-treatment
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Functional impairment related to knee osteoarthritis was assessed using the Lequesne algofunctional index, which evaluates pain, walking distance, and activities of daily living.
Higher scores reflect greater functional disability.
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baseline,immediately after treatment,and at 2 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps muscle strength assesed by isokinetic dynamometry
Time Frame: baseline,immediately after treatment and 2 monthspost treatment
|
Quadriceps muscle strength was measured using isokinetic dynamometry under standardized testing conditions.
Peak torque values were recorded to assess muscle strength performance.
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baseline,immediately after treatment and 2 monthspost treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Dilek Ün oguzhanasiltürk, Kanuni Sultan and Süleyman Training Resarch Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- okm-230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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