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Clinical Trials/NCT06753552
NCT06753552
Completed
Not Applicable

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

Kirsehir Ahi Evran Universitesi0 sites55 target enrollmentMarch 25, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis of Ankle
Sponsor
Kirsehir Ahi Evran Universitesi
Enrollment
55
Primary Endpoint
DAS-28
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2025
End Date
December 28, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Responsible Party
Principal Investigator
Principal Investigator

Ömer Faruk ÖZÇELEP

Researcher

Kirsehir Ahi Evran Universitesi

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

Outcomes

Primary Outcomes

DAS-28

Time Frame: 4 weeks

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

Manchester-Oxford Foot Questionnaire (MOXFQ)

Time Frame: 2 weeks

Health Assessment Questionnaire [HAQ]

Time Frame: 2 weeks

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

  • X-Ray(4 weeks)
  • Ankle Girth Measurement(4 weeeks)
  • Timed Up and Go Test(4 weeks)
  • Quebec User Evaluation of Satisfaction:(4 weeks)

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