Clinical trial NCT06753552: Combined Effect of Underwater Ultrasound
Official title: Combined Effect of Underwater Ultrasound and Custom-made Foot Orthotics in Patients With Rheumatoid Arthritis: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis of Ankle
Ultrasound Therapy; Complications
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DAS-28
timeFrame: 4 weeks
measure: Manchester-Oxford Foot Questionnaire (MOXFQ)
timeFrame: 2 weeks
measure: Health Assessment Questionnaire [HAQ]
timeFrame: 2 weeks
measure: Berg Balance Test
timeFrame: 4 weeks
Secondary outcomes:
measure: X-Ray
timeFrame: 4 weeks
measure: Ankle Girth Measurement
timeFrame: 4 weeeks
measure: Timed Up and Go Test
timeFrame: 4 weeks
measure: Quebec User Evaluation of Satisfaction:
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: