Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001036404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/07/2025
Date registered
Help: Date registered
19/09/2025
Date last updated
Help: Date last updated
20/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/09/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Performance of enthesitis ultrasound scoring systems in assessment of psoriatic arthritis disease activity
Scientific title
Performance of enthesitis ultrasound scoring systems in assessment of disease activity in adults with psoriatic arthritis
Additional trial identifiers [1] 314972 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psoriatic Arthritis 338288 0
Condition category
Condition code
Inflammatory and Immune System 334591 334591 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Musculoskeletal ultrasound to assess enthesitis in participants with psoriatic arthritis at baseline visit in Fiona Stanley Hospital/Harry Perkins Insitute of Research or Royal Perth Hospital. The ultrasound will be conducted at one study visit by Rheumatologist with experience with ultrasound. The ultrasound will last around 60 minutes and will involve 7 entheses sites (14 bilaterally) around the upper and lower limbs. Ultrasound will occur before clinical examination and patient questionnaires. The images will be graded by the rheumatologist according to different scoring systems based on presence of altered echogenicity/structure, thickening, erosion, enthesophyte, bursitis and doppler signals

Participants will be asked to avoid strenuous activity and taking any as needed steroids or anti-inflammatories on day of the visit. They will also be asked to avoid talking to the ultrasonographer about the status of their disease. There will be a separate researcher doing the physical examination and administering the patient questionnaires.
Intervention code [1] 331566 0
Diagnosis / Prognosis
Description of the comparator or control
There is no separate comparator/control group
All ultrasound enthesitis scores will be calculated on each participant and the scores will be compared to their PASDAS score.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342264 0
Comparison between the Glasgow ultrasound enthesitis scoring system and the Psoriatic Arthritis Disease Activity Score
Timepoint [1] 342264 0
At the baseline ultrasound visit and the 3 months' follow-up
Primary outcome [2] 342784 0
Comparison between the Madrid Sonographic Enthesis Index and the Psoriatic Arthritis Disease Activity Score
Timepoint [2] 342784 0
At the baseline ultrasound visit and the 3 months' follow-up
Primary outcome [3] 342785 0
Comparison between the Belgrade Ultrasound Enthesitis Score and the Psoriatic Arthritis Disease Activity Score
Timepoint [3] 342785 0
At the baseline ultrasound visit and the 3 months' follow-up
Secondary outcome [1] 450193 0
Comparison between the Spanish Sonographic Enthesitis Index and the Psoriatic Arthritis Disease Activity Score
Timepoint [1] 450193 0
At the baseline ultrasound visit and the 3 months' follow-up
Secondary outcome [2] 452104 0
Overall health status and quality of life
Timepoint [2] 452104 0
At the baseline ultrasound visit and the 3 months' follow-up
Secondary outcome [3] 452105 0
Patient reported global disease activity
Timepoint [3] 452105 0
At the baseline ultrasound visit and the 3 months' follow-up
Secondary outcome [4] 452106 0
Patient reported satisfaction with intervention
Timepoint [4] 452106 0
At the baseline ultrasound visit.
Secondary outcome [5] 459323 0
Comparison between the diagnostic ultrasound enthesitis tool and the Psoriatic Arthritis Disease Activity Score
Timepoint [5] 459323 0
At the baseline ultrasound visit and the 3 months' follow-up

Eligibility
Key inclusion criteria
• Participants are 18 years or over
• Participants who have been diagnosed with psoriatic arthritis
• Able to give consent for study

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Participants who are not able to cooperate with ultrasound examination – unable to follow instructions to lie supine and prone on examination bed.
• Participants with other inflammatory arthritis, fibromyalgia and/or chronic pain syndromes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/10/2025
Actual
21/01/2026
Date of last participant enrolment
Anticipated
28/08/2026
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
30
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319526 0
Hospital
Name [1] 319526 0
South Metropolitan Health Service (SMHS)
Country [1] 319526 0
Australia
Funding source category [2] 319953 0
Self funded/Unfunded
Name [2] 319953 0
Self-funded
Country [2] 319953 0
Australia
Primary sponsor type
Hospital
Name
Southern Metropolitan Health Service
Address
Country
Australia
Secondary sponsor category [1] 322025 0
None
Name [1] 322025 0
Address [1] 322025 0
Country [1] 322025 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318100 0
WA Health Central HREC
Ethics committee address [1] 318100 0
Ethics committee country [1] 318100 0
Australia
Date submitted for ethics approval [1] 318100 0
22/07/2025
Approval date [1] 318100 0
11/09/2025
Ethics approval number [1] 318100 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143118 0
Dr Yiling Zhang
Address 143118 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 143118 0
Australia
Phone 143118 0
+61449611225
Fax 143118 0
Email 143118 0
[email protected]
Contact person for public queries
Name 143119 0
Yiling Zhang
Address 143119 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 143119 0
Australia
Phone 143119 0
+61 449611225
Fax 143119 0
Email 143119 0
[email protected]
Contact person for scientific queries
Name 143120 0
Yiling Zhang
Address 143120 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 143120 0
Australia
Phone 143120 0
+61 449611225
Fax 143120 0
Email 143120 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data will be analysed and summarised in a de-identified form, individual participant data will not be shared.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.