Knee OsteoarthristisNCT07057869
Ultrasound Duration Effects on Knee Osteoarthritis Pain and Function
A study testing 5-minute Ultrasound Group, 10-minute Ultrasound Group and 15-minute Ultrasound Group in people with Knee Osteoarthristis, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of different ultrasound treatment durations on pain and physical function in patients with knee osteoarthritis. Sixty sedentary volunteers aged 18-85 with diagnosed knee osteoarthritis will be randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- 5-minute Ultrasound Group, 10-minute Ultrasound Group and 15-minute Ultrasound Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Jun 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 18 and 85 years Diagnosed with knee osteoarthritis Recommended for ultrasound therapy as part of routine physical therapy Willing to participate voluntarily and provide written informed consent
Who cannot join
- History of acute knee trauma Individuals with contraindications to ultrasound therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Different Ultrasound Treatment Durations on Pain and Physical Function in Patients With Knee Osteoarthritis
This study aims to compare the effects of different ultrasound treatment durations on pain and physical function in patients with knee osteoarthritis. Sixty sedentary volunteers aged 18-85 with diagnosed knee osteoarthritis will be randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes, respectively, alongside conventional treatment. Pain and physical function will be assessed using the Visual Analog Scale (VAS), WOMAC Osteoarthritis Index, and 2-minute walk test at baseline and after 4 weeks of treatment. The results will help determine the optimal ultrasound treatment duration for improving symptoms in knee osteoarthritis patients.
Read the detailed description
This clinical trial investigates the effects of different ultrasound therapy durations on pain relief and physical function improvement in patients with knee osteoarthritis. Sixty sedentary individuals aged 18 to 85 years diagnosed with knee osteoarthritis will be enrolled and randomly assigned to three groups receiving ultrasound treatment for 5, 10, or 15 minutes, respectively, alongside conventional therapy (such as hot packs, TENS, etc.).
Ultrasound therapy will be applied by a qualified physiotherapist at 1 W/cm² intensity and 1 MHz frequency in pulsed mode, for four weeks. Evaluations will be conducted at baseline and after treatment completion, using the Visual Analog Scale (VAS) for pain assessment, WOMAC Osteoarthritis Index for physical function, and a 2-minute walk test to measure walking performance.
This study aims to provide scientific evidence on the optimal ultrasound treatment duration for knee osteoarthritis, contributing to improved rehabilitation protocols. The findings will be prepared for publication in an international peer-reviewed journal.
- Conditions
- Knee Osteoarthristis
- Being tested
- 5-minute Ultrasound Group, 10-minute Ultrasound Group, 15-minute Ultrasound Group
- Keywords
- Knee Osteoarthritis, Ultrasound Therapy, Pain Management, Physical Function
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-minute Ultrasound GroupProcedure or surgery
Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 5 minutes per session, 4 weeks duration.
10-minute Ultrasound GroupProcedure or surgery
Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 10 minutes per session, 4 weeks duration.
15-minute Ultrasound GroupProcedure or surgery
Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 15 minutes per session, 4 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| 5-minute Ultrasound Group | Experimental | Patients receive 5 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. Receives: Procedure: 5-minute Ultrasound Group |
| 10-minute Ultrasound Group | Experimental | Patients receive 10 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. Receives: Procedure: 10-minute Ultrasound Group |
| 15-minute Ultrasound Group | Experimental | Patients receive 15 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. Receives: Procedure: 15-minute Ultrasound Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Assessment of knee pain intensity using the Visual Analog Scale (VAS) at baseline and after 4 weeks of treatment.
Measured: Baseline, 4 weeks
Physical Function (WOMAC)
Evaluation of physical function and stiffness using the WOMAC index at baseline and after 4 weeks of treatment.
Measured: Baseline, 4 weeks
Secondary outcomes (1)
Walking Distance (2-Min Walk)
Distance covered in 2 minutes walking test at baseline and after 4 weeks of treatment.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 May 2025
- Primary completion20 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies 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 a randomized controlled trial where 60 patients with knee osteoarthritis are randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes respectively. All groups receive conventional treatment alongside ultrasound therapy. The effects on pain and physical function are evaluated before and after a 4-week treatment period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Savaş Torlak, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057869
- Sponsor's protocol ID
- KaratayMST-2
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.
PubMed 18338277Paget C, Chow MT, Duret H, Mattarollo SR, Smyth MJ. Role of gammadelta T cells in alpha-galactosylceramide-mediated immunity. J Immunol. 2012 Apr 15;188(8):3928-39. doi: 10.4049/jimmunol.1103582. Epub 2012 Mar 12.
PubMed 22412194Rutjes AW, Nuesch E, Sterchi R, Juni P. Therapeutic ultrasound for osteoarthritis of the knee or hip. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003132. doi: 10.1002/14651858.CD003132.pub2.
PubMed 20091539Huang MH, Lin YS, Lee CL, Yang RC. Use of ultrasound to increase effectiveness of isokinetic exercise for knee osteoarthritis. Arch Phys Med Rehabil. 2005 Aug;86(8):1545-51. doi: 10.1016/j.apmr.2005.02.007.
PubMed 16084806Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.
PubMed 18496246
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Ultrasound Treatment Durations on Pain and Physical Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07057869
- Acronym / sponsor ID
- KaratayMST-2
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee Osteoarthritis, Ultrasound Therapy, Pain Management, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Jul 2025 (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.
This study aims to compare the effects of different ultrasound treatment durations on pain and physical function in patients with knee osteoarthritis. Sixty sedentary volunteers aged 18-85 with diagnosed knee osteoarthritis will be randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes, respectively, alongside conventional treatment. Pain and physical function will be assessed using the Visual Analog Scale (VAS), WOMAC Osteoarthritis Index, and 2-minute walk test at baseline and after 4 weeks of treatment. The results will help determine the optimal ultrasound treatment duration for improving symptoms in knee osteoarthritis patients.
Detailed description
This clinical trial investigates the effects of different ultrasound therapy durations on pain relief and physical function improvement in patients with knee osteoarthritis. Sixty sedentary individuals aged 18 to 85 years diagnosed with knee osteoarthritis will be enrolled and randomly assigned to three groups receiving ultrasound treatment for 5, 10, or 15 minutes, respectively, alongside conventional therapy (such as hot packs, TENS, etc.).
Ultrasound therapy will be applied by a qualified physiotherapist at 1 W/cm² intensity and 1 MHz frequency in pulsed mode, for four weeks. Evaluations will be conducted at baseline and after treatment completion, using the Visual Analog Scale (VAS) for pain assessment, WOMAC Osteoarthritis Index for physical function, and a 2-minute walk test to measure walking performance.
This study aims to provide scientific evidence on the optimal ultrasound treatment duration for knee osteoarthritis, contributing to improved rehabilitation protocols. The findings will be prepared for publication in an international peer-reviewed journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized controlled trial where 60 patients with knee osteoarthritis are randomly assigned to three groups receiving ultrasound therapy for 5, 10, or 15 minutes respectively. All groups receive conventional treatment alongside ultrasound therapy. The effects on pain and physical function are evaluated before and after a 4-week treatment period.
| Arm | Type | Receives |
|---|---|---|
| 5-minute Ultrasound Group | Experimental | Procedure: 5-minute Ultrasound GroupPatients receive 5 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. |
| 10-minute Ultrasound Group | Experimental | Procedure: 10-minute Ultrasound GroupPatients receive 10 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. |
| 15-minute Ultrasound Group | Experimental | Procedure: 15-minute Ultrasound GroupPatients receive 15 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged between 18 and 85 years Diagnosed with knee osteoarthritis Recommended for ultrasound therapy as part of routine physical therapy Willing to participate voluntarily and provide written informed consent
Key exclusion criteria (1 listed)
- History of acute knee trauma Individuals with contraindications to ultrasound therapy
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 |
|---|---|---|
| 5-minute Ultrasound GroupPulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 5 minutes per session, 4 weeks duration. | Procedure or surgery | 5-minute Ultrasound Group |
| 10-minute Ultrasound GroupPulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 10 minutes per session, 4 weeks duration. | Procedure or surgery | 10-minute Ultrasound Group |
| 15-minute Ultrasound GroupPulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 15 minutes per session, 4 weeks duration. | Procedure or surgery | 15-minute Ultrasound Group |
Primary outcome
Pain Intensity (VAS)
Time frame: Baseline, 4 weeks
Assessment of knee pain intensity using the Visual Analog Scale (VAS) at baseline and after 4 weeks of treatment.
Physical Function (WOMAC)
Time frame: Baseline, 4 weeks
Evaluation of physical function and stiffness using the WOMAC index at baseline and after 4 weeks of treatment.
1 secondary outcome
Walking Distance (2-Min Walk)
Time frame: Baseline, 4 weeks
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 10 Jul 2025.
- Results publication: PubMed 18338277Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.
- Results publication: PubMed 22412194Paget C, Chow MT, Duret H, Mattarollo SR, Smyth MJ. Role of gammadelta T cells in alpha-galactosylceramide-mediated immunity. J Immunol. 2012 Apr 15;188(8):3928-39. doi: 10.4049/jimmunol.1103582. Epub 2012 Mar 12.
- Results publication: PubMed 20091539Rutjes AW, Nuesch E, Sterchi R, Juni P. Therapeutic ultrasound for osteoarthritis of the knee or hip. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003132. doi: 10.1002/14651858.CD003132.pub2.
- Results publication: PubMed 16084806Huang MH, Lin YS, Lee CL, Yang RC. Use of ultrasound to increase effectiveness of isokinetic exercise for knee osteoarthritis. Arch Phys Med Rehabil. 2005 Aug;86(8):1545-51. doi: 10.1016/j.apmr.2005.02.007.
- Results publication: PubMed 18496246Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-minute Ultrasound Group, 10-minute Ultrasound Group and 15-minute Ultrasound Group in people with Knee Osteoarthristis, run by KTO Karatay University 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 10 Jul 2025. 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 (VAS) (time frame: Baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07057869, which also lists 5 linked publications.
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 10 Jul 2025.