Rheumatoid Arthritis of AnkleNCT06753552
Combined Effect of Underwater Ultrasound
A study testing Underwater US and CFO in people with Rheumatoid Arthritis of Ankle and Ultrasound Therapy; Complications, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis of Ankle, Ultrasound Therapy; Complications
- What is being tested?
- Underwater US and CFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University
Kırşehir, Ahi Evran, 40100
About this study
Official title: Combined Effect of Underwater Ultrasound and Custom-made Foot Orthotics in Patients With Rheumatoid Arthritis: A Randomised Controlled Trial
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.
Read the 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.
- Being tested
- Underwater US, CFO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater USOther
7 min per session with an intensity of 0.9 W/cm2 for 20 sessions
CFODevice
Custom made orthotics
| Study group | Role | What they receive |
|---|---|---|
| Underwater US+CFO | Experimental | Not described Receives: Other: Underwater US; Device: CFO |
| Underwater US | Active comparator | Not described Receives: Other: Underwater US |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS-28
Measures disease activity by evaluating 28 joints for swelling and tenderness.
Measured: 4 weeks
Manchester-Oxford Foot Questionnaire (MOXFQ)
Measured: 2 weeks
Health Assessment Questionnaire [HAQ]
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
Ankle Girth Measurement
https://orthofixar.com/special-test/ankle-girth-measurement/
Measured: 4 weeeks
Timed Up and Go Test
Measures overall mobility and fall risk.
Measured: 4 weeks
Quebec User Evaluation of Satisfaction:
Satisfaction of the custom made insoles
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start25 Mar 2025
- Primary completion25 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis of AnkleStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753552
- Sponsor's protocol ID
- AEU-FTR2
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: via e-mail perhaps
Publications
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 Jun;45(6):3067-3076. doi: 10.1007/s10067-026-08076-0. Epub 2026 Mar 28.
PubMed 41903071
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Underwater Ultrasound and Custom-made Foot Orthotics in Patients With Rheumatoid Arthritis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06753552
- Acronym / sponsor ID
- AEU-FTR2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Underwater US+CFO | Experimental | Other: Underwater US, Device: CFO |
| Underwater US | Active comparator | Other: Underwater US |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - 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.
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Underwater US7 min per session with an intensity of 0.9 W/cm2 for 20 sessions | Other | Underwater US, Underwater US+CFO |
| CFOCustom made orthotics | Device | Underwater US+CFO |
Primary outcome
DAS-28
Time frame: 4 weeks
Measures disease activity by evaluating 28 joints for swelling and tenderness.
Manchester-Oxford Foot Questionnaire (MOXFQ)
Time frame: 2 weeks
Health Assessment Questionnaire [HAQ]
Time frame: 2 weeks
Berg Balance Test
Time frame: 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.
3 secondary outcomes
Ankle Girth Measurement
Time frame: 4 weeeks
Timed Up and Go Test
Time frame: 4 weeks
Quebec User Evaluation of Satisfaction:
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 41903071Ozcelep 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 Jun;45(6):3067-3076. doi: 10.1007/s10067-026-08076-0. Epub 2026 Mar 28.
- Individual participant dataSharing planned: Undecided. via e-mail perhaps
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underwater US and CFO in people with Rheumatoid Arthritis of Ankle and Ultrasound Therapy; Complications, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS-28 (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.