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Combined Effect of Underwater Ultrasound

K

Kirsehir Ahi Evran Universitesi

Status

Not yet enrolling

Conditions

Rheumatoid Arthritis of Ankle
Ultrasound Therapy; Complications

Treatments

Device: CFO
Other: Underwater US

Study type

Interventional

Funder types

Other

Identifiers

NCT06753552
AEU-FTR2

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups

Underwater US+CFO
Experimental group
Treatment:
Other: Underwater US
Device: CFO
Underwater US
Active Comparator group
Treatment:
Other: Underwater US
Control
No Intervention group

Trial contacts and locations

0

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Central trial contact

Ömer Faruk Özçelep

Data sourced from clinicaltrials.gov

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