Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001149358p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
24/08/2026
Date registered
Help: Date registered
16/09/2026
Date last updated
Help: Date last updated
16/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
16/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Transparent Adhesive Film for Complex Regional Pain Syndrome (the FILM CRPS study).
Scientific title
The immediate impact of transparent adhesive film on allodynia in Complex Regional Pain Syndrome of the upper limb
Additional trial identifiers [1] 317632 0
NIL
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Complex Regional Pain Syndrome 342401 0
Condition category
Condition code
Anaesthesiology 338533 338533 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Application of non-invasive transparent adhesive film to an allodynic area
Delivered by an Advanced Occupational Therapist specialising in Pain management as an individual, face to face, single session in the clinical setting.
The duration of the application of the adhesive film will be at a minimum of 10 - 15 mins in order to conduct post outcome measures, unless otherwise indicated.
The film which is < 1mm in thickness will be applied to a section of the allodynic area, a patch size of 2.5cm x 5 cm. This may vary depending on the size of the area of allodynia.
The application of the film is only required to remain in situ whilst post outcome measures are taken which is approximately 10 - 15 mins. Continued use of the adhesive film is optional.
Intervention code [1] 334450 0
Treatment: Other
Intervention code [2] 334451 0
Rehabilitation
Intervention code [3] 334461 0
Behaviour
Description of the comparator or control
No control group
Comparison using outcome measures pre and post application of non-invasive adhesive film
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345812 0
The aim of this study is to determine the immediate impact of flexible adhesive film on CPRS-related allodynia. The key study questions for this project includes: 1) For patients with allodynia as a result of CRPS, does applying flexible adhesive film to part of affected upper limb immediately impact: - tolerance of light touch with tissue (assessed via numerical scale questionnaire)
Timepoint [1] 345812 0
Single session Baseline prior to application and post application of adhesive film @ 10 - 15 mins
Primary outcome [2] 345819 0
Diminish the response to thermal stimulus:
Timepoint [2] 345819 0
single session Baseline prior to application and post application of adhesive film
Primary outcome [3] 346799 0
The key study questions for this project includes: 1) For patients with allodynia as a result of CRPS, does applying flexible adhesive film to part of affected upper limb immediately impact: - pressure-pain threshold (assessed via pressure algometer)
Timepoint [3] 346799 0
Single session Baseline prior to application and post application of adhesive film @ 10 - 15 mins
Secondary outcome [1] 463416 0
Influence ability to complete a patient-identified functional task:
Timepoint [1] 463416 0
single session Pre application and post application of adhesive film

Eligibility
Key inclusion criteria
Medical referral to Occupational Therapy at the Tess Cramond Pain and Research Centre with a diagnosis of complex regional pain syndrome.
Diagnosis of allodynia in the context of CRPS of the upper limb
English speaking
Adults 18 yrs +
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Allergy to adhesive tape

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
Efficacy
Statistical methods / analysis
10 participants

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/12/2026
Actual
Date of last participant enrolment
Anticipated
4/12/2028
Actual
Date of last data collection
Anticipated
4/12/2028
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 29654 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 45999 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 322172 0
Hospital
Name [1] 322172 0
Royal Brisbane and Women's Hospital
Country [1] 322172 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 325073 0
None
Name [1] 325073 0
Address [1] 325073 0
Country [1] 325073 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 320704 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 320704 0
Ethics committee country [1] 320704 0
Australia
Date submitted for ethics approval [1] 320704 0
21/09/2026
Approval date [1] 320704 0
Ethics approval number [1] 320704 0

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

Contacts
Principal investigator
Name 151342 0
Mrs Linda Atkinson
Address 151342 0
Occupational Therapy Department, RBWH, Butterfield Street, HERSTON Q. 4006
Country 151342 0
Australia
Phone 151342 0
+61 0736476100
Fax 151342 0
Email 151342 0
[email protected]
Contact person for public queries
Name 151343 0
Linda Atkinson
Address 151343 0
Occupational Therapy Department, RBWH, Butterfield Street, HERSTON Q 4006
Country 151343 0
Australia
Phone 151343 0
+61 0736476100
Fax 151343 0
Email 151343 0
[email protected]
Contact person for scientific queries
Name 151344 0
Dr Andrew Claus
Address 151344 0
Tess Cramond Pain and Research Centre (TCPRC), RBWH, Butterfield Street, HERSTON Q 4006
Country 151344 0
Australia
Phone 151344 0
+61 07 3647 6961
Fax 151344 0
Email 151344 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The Royal Brisbane and Women's Hospital requires that individual participant data are stored securely with password protection on their servers.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol   QST and opsite protocol_v1_26-5-2026.docx
Informed consent form    Opsite pilot_PICF_v1_26-5-2026.docx


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.