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Completed

NCT Number: NCT06753552

Combined Effect of Underwater Ultrasound

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahi Evran University

Kırşehir, Ahi Evran, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Underwater US

Other

7 min per session with an intensity of 0.9 W/cm2 for 20 sessions

CFO

Device

Custom made orthotics

Primary outcomes

  1. DAS-28

    Time frame: 4 weeks

    Measures disease activity by evaluating 28 joints for swelling and tenderness.

  2. Manchester-Oxford Foot Questionnaire (MOXFQ)

    Time frame: 2 weeks

  3. Health Assessment Questionnaire [HAQ]

    Time frame: 2 weeks

  4. Berg Balance Test

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Ankle Girth Measurement

    Time frame: 4 weeeks

    https://orthofixar.com/special-test/ankle-girth-measurement/

  2. Timed Up and Go Test

    Time frame: 4 weeks

    Measures overall mobility and fall risk.

  3. Quebec User Evaluation of Satisfaction:

    Time frame: 4 weeks

    Satisfaction of the custom made insoles

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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