Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000474358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/04/2026
Date registered
Help: Date registered
16/04/2026
Date last updated
Help: Date last updated
16/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
16/04/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of diagnostic imaging information on patient understanding, beliefs and treatment intentions in Femoroacetabular Impingement (FAI) syndrome: An online randomised trial
Scientific title
Effect of diagnostic imaging information on patient understanding, beliefs and treatment intentions in Femoroacetabular Impingement (FAI) syndrome: An online randomised trial
Additional trial identifiers [1] 316311 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Femoroacetabular impingement syndrome 340361 0
Health literacy 341467 0
Condition category
Condition code
Musculoskeletal 336563 336563 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All participants will be asked to read a brief, hypothetical scenario describing a person experiencing ongoing moderate hip pain that limits usual activities. Participants will then be randomly assigned to one of two groups:
1. Control group: Participants will receive standard diagnostic imaging X-ray and MRI reports describing structural findings consistent with morphology associated with FAI syndrome.
2. Intervention group: Participants will receive the same standard imaging reports, plus an additional imaging infographic designed to explain the imaging findings in lay language. This infographic provides context about what the structural changes mean, emphasising that these findings are common, not necessarily the sole cause of symptoms, and that physiotherapy is recommended as first-line treatment.
The intervention materials were developed based on current clinical guidelines for FAI syndrome, and consumer feedback (physiotherapists and people with lived experience of FAI syndrome) on information preferences, and the infographic was adapted based on feedback from consumers.

This intervention will be embedded within the single secure online Research Data Capture (REDCap) link. The hypothetical scenario and assigned materials will take approximately 10-20 minutes to review. Participants will be asked to check a box confirming they have reviewed required materials before progressing to the outcome survey. As this is an anonymous online survey, adherence to the intervention (i.e., review of materials in full) cannot be monitored or verified. However, the decision was made to provide no monetary incentive for participation to mitigate the risk of non-engaged or repeat submissions.

The nine-item outcome survey will take no more than 20 minutes to complete, with nine questions related to their understanding of the imaging findings, information-seeking intentions, treatment beliefs and intentions (surgery and physiotherapy), concern about symptom progression, and confidence in managing their hip pain conservatively.

The primary difference between groups lies in the provision of the additional explanatory infographic, aimed at improving patient understanding, reducing worry and supporting engagement with first-line conservative management.

A brief post-intervention fidelity questionnaire will be administered following completion of the outcome measures to assess participant engagement with and review of the intervention materials. The questionnaire will consist of simple questions relating to key information contained within the given materials.
Intervention code [1] 332968 0
Behaviour
Description of the comparator or control
Group receiving standard x-ray and MRI reports only with common terminology associated with FAI syndrome.
Control group
Active

Outcomes
Primary outcome [1] 344073 0
Treatment beliefs
Timepoint [1] 344073 0
Immediately post-review of hypothetical scenario and allocated materials
Primary outcome [2] 344726 0
Understanding of imaging reports
Timepoint [2] 344726 0
Immediately post-review of hypothetical scenario and allocated materials
Primary outcome [3] 345037 0
Treatment intentions
Timepoint [3] 345037 0
Immediately post-review of hypothetical scenario and allocated materials
Secondary outcome [1] 456649 0
Information seeking intentions
Timepoint [1] 456649 0
Immediately post-review of hypothetical scenario and allocated materials
Secondary outcome [2] 460244 0
Confidence managing hip pain conservatively
Timepoint [2] 460244 0
Immediately post-review of hypothetical scenario and allocated materials
Secondary outcome [3] 460245 0
Concern about symptom progression
Timepoint [3] 460245 0
Immediately post-review of hypothetical scenario and allocated materials

Eligibility
Key inclusion criteria
i) Adults aged 18-50 years with or without hip pain
ii) Located in Australia at time of survey completion
iii) understand written English

Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Aside from meeting the inclusion criteria, there are no key exclusion criteria for this study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed using an automated, computer-generated randomisation sequence embedded within the online survey platform. Group assignment occurs only after participants have consented and commenced the survey, ensuring allocation is not known in advance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomisation (blocks of 6)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/07/2026
Actual
Date of last participant enrolment
Anticipated
11/12/2026
Actual
Date of last data collection
Anticipated
11/12/2026
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320906 0
Government body
Name [1] 320906 0
NHMRC
Country [1] 320906 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 323599 0
University
Name [1] 323599 0
La Trobe Sport and Exercise Medicine Research Centre
Address [1] 323599 0
Country [1] 323599 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319448 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 319448 0
Ethics committee country [1] 319448 0
Australia
Date submitted for ethics approval [1] 319448 0
17/03/2026
Approval date [1] 319448 0
31/03/2026
Ethics approval number [1] 319448 0
HEC26078

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

Contacts
Principal investigator
Name 147354 0
Prof Joanne Kemp
Address 147354 0
La Trobe University, Plenty Rd, Bundoora 3086 VIC
Country 147354 0
Australia
Phone 147354 0
+61 394791428
Fax 147354 0
Email 147354 0
[email protected]
Contact person for public queries
Name 147355 0
Joanne Kemp
Address 147355 0
La Trobe University, Plenty Rd, Bundoora 3086 VIC
Country 147355 0
Australia
Phone 147355 0
+61 394791428
Fax 147355 0
Email 147355 0
[email protected]
Contact person for scientific queries
Name 147356 0
Joanne Kemp
Address 147356 0
La Trobe University, Plenty Rd, Bundoora 3086 VIC
Country 147356 0
Australia
Phone 147356 0
+61 394791428
Fax 147356 0
Email 147356 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.