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Trial registered on ANZCTR


Registration number
ACTRN12624000329561
Ethics application status
Approved
Date submitted
22/12/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Use of 3D-Printed Silicone Toe Separator on Adults with Bunions: Uncontrolled Intervention Trial
Scientific title
The Use of 3D-Printed Silicone Toe Separator on Foot Pain in Adults with Hallux Valgus: Uncontrolled Intervention Trial
Secondary ID [1] 311243 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
foot pain associated with hallux valgus 332457 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329152 329152 0 0
Physiotherapy
Musculoskeletal 329667 329667 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient with hallux valgus receives 3D-printed silicone toe separator and use it for the complete 12-week duration of the study. The patients must wear the silicone toe separators during the night for a minimum of 4 hours as recommended by a physiatrist. They must record wearing hours daily and being examined by a physiatrist after 2 and 12 weeks of intervention.
Intervention code [1] 327699 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336983 0
pain
Timepoint [1] 336983 0
timepoint: baseline, and 2 and 12 weeks post-commencement of intervention
Secondary outcome [1] 430299 0
foot function
Timepoint [1] 430299 0
Baseline and 2 and 12 weeks post-commencement of intervention
Secondary outcome [2] 430300 0
hallux valgus angle
Timepoint [2] 430300 0
baseline, and 12 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Hallux valgus patients with pain score between 3 to 8 for a minimum of 4 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who has rigid foot deformity, a previous 1-year foot surgery, a medical history of steroid injections within the past 3 months, and other health problems associated with walking ability such as knee arthritis, diabetes, peripheral artery disease, and peripheral neuropathy were excluded.

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
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2023
Date of last participant enrolment
Anticipated
Actual
30/03/2023
Date of last data collection
Anticipated
Actual
13/09/2023
Sample size
Target
25
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 26055 0
Thailand
State/province [1] 26055 0

Funding & Sponsors
Funding source category [1] 315499 0
Government body
Name [1] 315499 0
Health Systems Research Institute (HSRI)
Country [1] 315499 0
Thailand
Primary sponsor type
Government body
Name
National Science and Technology Development Agency (NSTDA)
Address
111 Thailand Science Park, Pathumthani
Country
Thailand
Secondary sponsor category [1] 317574 0
University
Name [1] 317574 0
Thammasat University
Address [1] 317574 0
Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Thammasat University
Country [1] 317574 0
Thailand
Secondary sponsor category [2] 317575 0
Hospital
Name [2] 317575 0
Thammasat University Hospital
Address [2] 317575 0
Department of Physical Medicine and Rehabilitation, Thammasat University Hospital
Country [2] 317575 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314403 0
Ethics Committee of Thammasat University
Ethics committee address [1] 314403 0
99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand
Ethics committee country [1] 314403 0
Thailand
Date submitted for ethics approval [1] 314403 0
22/11/2022
Approval date [1] 314403 0
20/01/2023
Ethics approval number [1] 314403 0
MTU-EC-OO-4-264/65

Summary
Brief summary
Hallux valgus presents with pain and a progressive valgus deformity of the first ray. The newly designed silicone toe separators fabricated by 3D printing technology are used for 12-week treatment. The pain score and foot function index (FFI) are rated, and hallux valgus angle are measured before and after intervention to investigate the treatment effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131458 0
Dr Siranya Paecharoen
Address 131458 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand.
Country 131458 0
Thailand
Phone 131458 0
+6629269225
Fax 131458 0
Email 131458 0
[email protected]
Contact person for public queries
Name 131459 0
Siranya Paecharoen
Address 131459 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand.
Country 131459 0
Thailand
Phone 131459 0
+6629269225
Fax 131459 0
Email 131459 0
[email protected]
Contact person for scientific queries
Name 131460 0
Siranya Paecharoen
Address 131460 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand.
Country 131460 0
Thailand
Phone 131460 0
+6629269225
Fax 131460 0
Email 131460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.