THERAPEUTIC ULTRASOUND IN PATIENTS WITH KNEE OSTEOARTHRITIS

January 6, 2026 updated by: Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Prof .Dr .Cemil Taşcioğlu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: continius ultrasound group
hot pack,tens,exercise terapy ,continius ultasound
Device: hot pack
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
Device: transcutaneus electrical nerve stimulatıon
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Behavioral: exersice terapy
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.
Device: continius ultrasound
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
Device: hot pack
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
Device: transcutaneus electrical nerve stimulatıon
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Behavioral: exersice terapy
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.
Device: pulsed ultrasound
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.
Experimental: control group
hot pack,tens,exercise terapy
Device: hot pack
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
Device: transcutaneus electrical nerve stimulatıon
TENS is a non-invasive electrical stimulation technique applied through surface electrodes to modulate sensory nerve activity without producing muscle contraction.
Behavioral: exersice terapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
baseline,immediately after treatment, and 2 months post-tratment
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.
baseline,immediately after treatment and at 2 months post treatment
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.
baseline,immediately after treatment,and at 2 months post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
baseline,immediately after treatment and 2 monthspost treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilek Ün oguzhanasiltürk, Kanuni Sultan and Süleyman Training Resarch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • okm-230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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