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Combined Effect of Underwater Ultrasound

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753552
Enrollment
55
Registered
2024-12-31
Start date
2025-03-25
Completion date
2025-12-28
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis of Ankle, Ultrasound Therapy; Complications

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.

Interventions

OTHERUnderwater US

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

DEVICECFO

Custom made orthotics

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DAS-284 weeksMeasures 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 Test4 weeksUseful 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

MeasureTime frameDescription
Ankle Girth Measurement4 weeekshttps://orthofixar.com/special-test/ankle-girth-measurement/
Timed Up and Go Test4 weeksMeasures overall mobility and fall risk.
Quebec User Evaluation of Satisfaction:4 weeksSatisfaction of the custom made insoles

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026