Combined Effect of Underwater Ultrasound

Combined Effect of Underwater Ultrasound and Custom-made Foot Orthotics in Patients With Rheumatoid Arthritis: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound Therapy; Complications; Rheumatoid Arthritis of Ankle
• Intervention / Treatment: Other: Underwater US; Device: CFO

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ahi Evran
    • Kırşehir, Ahi Evran, Turkey (Türkiye), 40100
      • Ahi Evran University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Underwater US+CFO	Other: Underwater US; 7 min per session with an intensity of 0.9 W/cm2 for 20 sessions; Device: CFO; Custom made orthotics
Active Comparator: Underwater US	Other: Underwater US; 7 min per session with an intensity of 0.9 W/cm2 for 20 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	4 weeks
Quebec User Evaluation of Satisfaction:	Satisfaction of the custom made insoles	4 weeks

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): December 28, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: AEU-FTR2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: via e-mail perhaps

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No