Combined Effect of Underwater Ultrasound

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis of Ankle; Ultrasound Therapy; Complications

• Registration Number: NCT06753552
• Lead Sponsor: Kirsehir Ahi Evran Universitesi

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Start: 2025-02-25
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DAS-28	4 weeks	Measures disease activity by evaluating 28 joints for swelling and tenderness.
Manchester-Oxford Foot Questionnaire (MOXFQ)	2 weeks
Health Assessment Questionnaire [HAQ]	2 weeks
Berg Balance Test	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 Outcome Measures

Name	Time	Method
X-Ray	4 weeks	Hallux Valgus or metatarsus primus varus angle
Ankle Girth Measurement	4 weeeks	https://orthofixar.com/special-test/ankle-girth-measurement/
Timed Up and Go Test	4 weeks	Measures overall mobility and fall risk.
Quebec User Evaluation of Satisfaction:	4 weeks	Satisfaction of the custom made insoles