Knee OsteoarthritisNCT07323030
THERAPEUTIC ULTRASOUND IN PATIENTS WITH KNEE OSTEOARTHRITIS
A study testing hot pack, transcutaneus electrical nerve stimulatıon and exersice terapy in people with Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- hot pack, transcutaneus electrical nerve stimulatıon and exersice terapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Sep 2010
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof .Dr .Cemil Taşcioğlu City Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- hot pack, transcutaneus electrical nerve stimulatıon, exersice terapy, continius ultrasound, pulsed ultrasound
- Keywords
- Therapeutic ultrasound, Physical Therapy, Ultrasound application techniques, Knee pain, Functional outcome
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot packDevice
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
transcutaneus electrical nerve stimulatıonDevice
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
exersice terapyBehavioural
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.
continius ultrasoundDevice
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.
pulsed ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| continius ultrasound group | Experimental | hot pack,tens,exercise terapy ,continius ultasound Receives: Device: hot pack; Device: transcutaneus electrical nerve stimulatıon; Behavioral: exersice terapy; Device: continius ultrasound |
| pulse ultrasound group | Experimental | hot pack,tens,exercise terapy,pulsed ultrasound Receives: Device: hot pack; Device: transcutaneus electrical nerve stimulatıon; Behavioral: exersice terapy; Device: pulsed ultrasound |
| control group | Experimental | hot pack,tens,exercise terapy Receives: Device: hot pack; Device: transcutaneus electrical nerve stimulatıon; Behavioral: exersice terapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity assessed by visuel analog scale (VAS)
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.
Measured: baseline,immediately after treatment, and 2 months post-tratment
knee joint stiffness assessed by WOMAC stiffness subscale
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.
Measured: baseline,immediately after treatment and at 2 months post treatment
lesquesne algofunctional ındex score
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.
Measured: baseline,immediately after treatment,and at 2 months post-treatment
Secondary outcomes (1)
Quadriceps muscle strength assesed by isokinetic dynamometry
Quadriceps muscle strength was measured using isokinetic dynamometry under standardized testing conditions. Peak torque values were recorded to assess muscle strength performance.
Measured: baseline,immediately after treatment and 2 monthspost treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startJun 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- This is prosrective ,parallel group interventional study evaluating the effectiveness of therapeutic ultrasound in patients with gonartrosis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Dilek Ün oguzhanasiltürk, Principal investigator, Kanuni Sultan and Süleyman Training Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323030
- Sponsor's protocol ID
- okm-230
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: İndividual participipant data will not be shared,as data sharing was not included in the study protocol and ethics committee approval ,and paricipant confidentiality must be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TWO DIFFERENT THERAPEUTIC ULTRASOUND TECHNIQUES IN COMBINATION WITH STANDARD PHYSICAL THERAPY VERSUS STANDARD PHYSICAL THERAPY ALONE IN PATIENTS WITH KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT07323030
- Acronym / sponsor ID
- okm-230
- Conditions
- Knee Osteoarthritis
- Keywords
- Therapeutic ultrasound, Physical Therapy, Ultrasound application techniques, Knee pain, Functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Jan 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is prosrective ,parallel group interventional study evaluating the effectiveness of therapeutic ultrasound in patients with gonartrosis
| Arm | Type | Receives |
|---|---|---|
| continius ultrasound group | Experimental | Device: hot pack, Device: transcutaneus electrical nerve stimulatıon, Behavioral: exersice terapy, Device: continius ultrasoundhot pack,tens,exercise terapy ,continius ultasound |
| pulse ultrasound group | Experimental | Device: hot pack, Device: transcutaneus electrical nerve stimulatıon, Behavioral: exersice terapy, Device: pulsed ultrasoundhot pack,tens,exercise terapy,pulsed ultrasound |
| control group | Experimental | Device: hot pack, Device: transcutaneus electrical nerve stimulatıon, Behavioral: exersice terapyhot pack,tens,exercise terapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| hot packsuperficial 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 | Device | continius ultrasound group, control group, pulse ultrasound group |
| transcutaneus electrical nerve stimulatıonTENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction. | Device | continius ultrasound group, control group, pulse ultrasound group |
| exersice terapyExercise 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. | Behavioural | continius ultrasound group, control group, pulse ultrasound group |
| continius ultrasoundContinuous 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. | Device | continius ultrasound group |
| pulsed ultrasoundPulsed 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. | Device | pulse ultrasound group |
Primary outcome
pain intensity assessed by visuel analog scale (VAS)
Time frame: baseline,immediately after treatment, and 2 months post-tratment
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.
knee joint stiffness assessed by WOMAC stiffness subscale
Time frame: baseline,immediately after treatment and at 2 months post treatment
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.
lesquesne algofunctional ındex score
Time frame: baseline,immediately after treatment,and at 2 months post-treatment
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.
1 secondary outcome
Quadriceps muscle strength assesed by isokinetic dynamometry
Time frame: baseline,immediately after treatment and 2 monthspost treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. İndividual participipant data will not be shared,as data sharing was not included in the study protocol and ethics committee approval ,and paricipant confidentiality must be maintained.
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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.
Dilek Ün oguzhanasiltürk principal investigator
Kanuni Sultan and Süleyman Training Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot pack, transcutaneus electrical nerve stimulatıon and exersice terapy in people with Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity assessed by visuel analog scale (VAS) (time frame: baseline,immediately after treatment, and 2 months post-tratment). 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 7 Jan 2026.