Combined Effect of Underwater Ultrasound | NCT06753552

Studies
Combined Effect of Underwater Ultrasound

NCT06753552

Sponsor

Kirsehir Ahi Evran Universitesi

Status

Completed

Last Update Posted

Jan 22, 2026Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Rheumatoid Arthritis of Ankle
Ultrasound Therapy; Complications

Interventions

Underwater US
CFO

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2025Actual

Primary Completion Date

Dec 25, 2025Actual

Completion Date

Dec 28, 2025Actual

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Dec 22, 2024

First Posted Date

Dec 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 22, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ömer Faruk ÖZÇELEP, Researcher, Kirsehir Ahi Evran UniversitesiPrincipal Investigator

Lead Sponsor

Kirsehir Ahi Evran UniversitesiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomised controlled trial aims to investigate the effects of underwater ultrasound therapy and customised foot insoles in RA patients. The study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. The research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of RA patients.

Detailed Description

Rheumatoid arthritis (RA) is a chronic inflammatory disease that can cause pain, swelling, limitation of movement and deformities in the joints (Cabrera-Sánchez et al. 2024)(Cabrera-Sánchez et al. 2024). Foot and ankle involvement is quite common in RA patients and this may adversely affect the daily living activities of patients. In addition to pharmacological approaches, physical therapy methods and the use of biomechanical supports are also important in the treatment of RA.

Ultrasound is a physical therapy method used to reduce pain and inflammation and accelerate tissue healing (Király et al. 2021). Underwater ultrasound applications may be more effective in superficial areas and may reduce the risk of damage to sensitive tissues around the joint. On the other hand, customised foot insoles (orthotics) are frequently used to correct foot deformities, eliminate biomechanical imbalances and reduce pain (Gaino et al. 2021).

This randomised controlled trial aims to examine the effects of underwater ultrasound therapy and customised foot insoles in RA patients. The study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. The research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of RA patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Underwater US+CFO	Experimental	Other: Underwater US Device: CFO
Underwater US	Active Comparator	Other: Underwater US
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Underwater US	Other	7 min per session with an intensity of 0.9 W/cm2 for 20 sessions	Underwater US Underwater US+CFO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DAS-28	Measures disease activity by evaluating 28 joints for swelling and tenderness.	4 weeks
Manchester-Oxford Foot Questionnaire (MOXFQ)		2 weeks
Health Assessment Questionnaire [HAQ]		2 weeks
Berg Balance Test	Useful for the measurement of the risk of falls and for demonstrating the progress patients in exercise programs oriented to the improve of balance for falls prevention.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Ankle Girth Measurement	https://orthofixar.com/special-test/ankle-girth-measurement/	4 weeeks
Timed Up and Go Test	Measures overall mobility and fall risk.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- ACR/EULAR 2010 diagnostic criteria with foot involvement and having a disease duration of less than two years were enrolled in the study over a period of three months.
with foot involvement diagnosed by a rheumatologist.

Exclusion Criteria:

- Degenerative diseases and anatomical abnormalities were excluded
if they presented in an acute symptomatic flare or they needed to use walking assistance
neurological problems, malignant process, cognitive deterioration, pregnancy, previous foot surgery and the presence of a foot wound

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahi Evran University		Kırşehir	Ahi Evran	40100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41903071	Derived	Ozcelep OF, Demir C, Okumus EC, Canli M, Alkan H. Combined effect of underwater ultrasound and custom-made insoles in rheumatoid arthritis: a randomized controlled trial. Clin Rheumatol. 2026 Jun;45(6):3067-3076. doi: 10.1007/s10067-026-08076-0. Epub 2026 Mar 28.