NCT07057869

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 30, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

Knee Osteoarthritis, Ultrasound Therapy, Pain Management, Physical Function

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity (VAS)

    Assessment of knee pain intensity using the Visual Analog Scale (VAS) at baseline and after 4 weeks of treatment.

    Baseline, 4 weeks

  • Physical Function (WOMAC)

    Evaluation of physical function and stiffness using the WOMAC index at baseline and after 4 weeks of treatment.

    Baseline, 4 weeks

Secondary Outcomes (1)

  • Walking Distance (2-Min Walk)

    Baseline, 4 weeks

Study Arms (3)

5-minute Ultrasound Group

EXPERIMENTAL

Patients receive 5 minutes of pulsed ultrasound therapy (1 W/cm², 1 MHz) alongside conventional treatment for 4 weeks.

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.

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.

Procedure: 15-minute Ultrasound Group

Interventions

Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 5 minutes per session, 4 weeks duration.

5-minute Ultrasound Group

Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 10 minutes per session, 4 weeks duration.

10-minute Ultrasound Group

Pulsed ultrasound therapy applied at 1 W/cm² intensity and 1 MHz frequency for 15 minutes per session, 4 weeks duration.

15-minute Ultrasound Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of acute knee trauma Individuals with contraindications to ultrasound therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay Üniversitesi

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • Paget 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.

  • Rutjes 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.

  • Huang 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.

  • Cetin 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.

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is an open-label trial where both patients and treating physiotherapists are aware of the ultrasound treatment duration. Outcome assessors are blinded to group assignments to reduce assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 10, 2025

Study Start

May 1, 2025

Primary Completion

June 20, 2025

Study Completion

June 30, 2025

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations