Combined Effect of Underwater Ultrasound
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2025
CompletedJanuary 22, 2026
December 1, 2024
9 months
December 19, 2024
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
DAS-28
Measures disease activity by evaluating 28 joints for swelling and tenderness.
4 weeks
Manchester-Oxford Foot Questionnaire (MOXFQ)
2 weeks
Health Assessment Questionnaire [HAQ]
2 weeks
Berg Balance Test
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.
4 weeks
Secondary Outcomes (3)
Ankle Girth Measurement
4 weeeks
Timed Up and Go Test
4 weeks
Quebec User Evaluation of Satisfaction:
4 weeks
Study Arms (3)
Underwater US+CFO
EXPERIMENTALUnderwater US
ACTIVE COMPARATORControl
NO INTERVENTIONInterventions
7 min per session with an intensity of 0.9 W/cm2 for 20 sessions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahi Evran University
Kırşehir, Ahi Evran, 40100, Turkey (Türkiye)
Related Publications (1)
Ozcelep OF, Demir C, Okumus EC, Canli M, Alkan H. Combined effect of underwater ultrasound and custom-made insoles in rheumatoid arthritis: a randomized controlled trial. Clin Rheumatol. 2026 Mar 28. doi: 10.1007/s10067-026-08076-0. Online ahead of print.
PMID: 41903071DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 31, 2024
Study Start
March 25, 2025
Primary Completion
December 25, 2025
Study Completion
December 28, 2025
Last Updated
January 22, 2026
Record last verified: 2024-12