3D-printed vs thermoformed orthosis for trigger finger and hyperextension of the proximal interphalangeal joint
| ISRCTN | ISRCTN15096059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15096059 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Centre Hospitalier de l’Université de Montréal, Université du Québec à Trois-Rivières |
| Funder | Université du Québec à Trois-Rivières |
- Submission date
- 08/11/2025
- Registration date
- 11/11/2025
- Last edited
- 11/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study is exploring a new way to make orthoses (hand supports) using 3D printing technology. These supports are used to help people with a condition called trigger finger, which causes pain and stiffness in the fingers. Although 3D printing has many advantages over traditional methods, it’s not yet commonly used in clinics. The aim of this study is to see how acceptable and useful 3D-printed orthoses are for patients and healthcare professionals.
Who can participate?
Adults aged 18 years and over who have trigger finger can take part in the study. Both men and women will be included, and participants will be recruited from different healthcare centres.
What does the study involve?
Participants will join online meetings using Microsoft Teams or Zoom. They will receive a custom-made 3D-printed orthosis to wear. They will also be asked to fill out questionnaires about their pain and hand function at five different times: before wearing the orthosis, and then 24 hours, 1 week, 1 month, and 2 months after starting to wear it. All questionnaires can be completed from home using a phone or computer.
What are the possible benefits and risks of participating?
Participants may benefit from reduced pain and improved finger movement thanks to the orthosis. However, wearing it might be uncomfortable and could cause skin irritation or pain due to limited finger movement. The study also requires some time commitment—about 30 minutes online and around 15 minutes to complete questionnaires at each of the five time points.
Where is the study run from?
The study is being run by Université du Québec à Trois-Rivières (UQTR) in Canada.
When is the study starting and how long is it expected to run for?
June 2025 to December 2026
Who is funding the study?
Projet 2024-2025 de la Planification stratégique institutionnelle de l’UQTR (Canada)
Who is the main contact?
The main contact for the study is Tokiko Hamasaki, an occupational therapist and PhD researcher at UQTR.
tokiko.hamasaki@uqtr.ca
Contact information
Principal investigator
555 Boulevard de l'Université, Bureau 2021
Drummondville
J2C 0R5
Canada
 ORCID ID |
0000-0002-9514-0676 |
|---|---|
| Phone | +1 819-478-5011, 2903 |
| tokiko.hamasaki@uqtr.ca |
Scientific
1000 rue St-Denis, DS350-DS450
Montréal
H2X OC1
Canada
| ORCID ID |
0000-0002-1057-9883 |
|---|---|
| Phone | +1 514-890-8000, ext. 11126 |
| stephane.bedwani.chum@ssss.gouv.qc.ca |
Public
3351 Boulevard des Forges
Trois-Rivières
G8Z 4M3
Canada
| Phone | +1 819-376-5064 |
|---|---|
| emma.brown@uqtr.ca |
Public
850 Boulevard de Maisonneuve Est, 3e-4e étages
Montréal
H2L 4L8
Canada
| Phone | +1 514-623-4531 |
|---|---|
| william.beauchemin@umontreal.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Quasi-experimental crossover study with repeated measures |
| Secondary study design | Quasi-experimental crossover study |
| Study type | Participant information sheet |
| Scientific title | Comparison of 3D-printed and thermoformed orthosis fabrication methods for trigger finger and hyperextension of the proximal interphalangeal joint: a pilot study |
| Study objectives | This project aims to evaluate whether 3D-printed orthosis is acceptable in a clinical setting, both for professionals and for patients with trigger finger and hyperextension of the proximal interphalangeal joint. This technology, which is still rarely used in this field, could offer practical and clinical advantages over traditional methods. |
| Ethics approval(s) |
Approved 14/10/2025, Comité d'éthique de la recherche du CIUSSS de la Mauricie-et-du-Centre-du-Québec (2700, boulevard des Forges, bureau 302, Trois-Rivières, G8Z 1V2, Canada; +1 819 372-3133, poste 32303; 04ethiqueciusssmcq@ssss.gouv.qc.ca), ref: MP-29-2026-895, 1025 |
| Health condition(s) or problem(s) studied | Trigger finger and hyperextension of the proximal interphalangeal joint |
| Intervention | The study design is semi-experimental; thus, there is no randomization, and there is only one arm for which the treatment is a 3D-printed orthosis. Every participant will wear the 3D orthosis and the thermoformed orthosis (control). They will wear each orthosis for a total of 2 months. The participants will answer a questionnaire assessing their symptoms before wearing the orthosis and questionnaires about the orthosis 24 hours, 1 week, 1 month and 2 months after beginning to wear the orthosis. They will not wear the 3D orthosis and the thermoformed orthosis at the same time. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Pain and upper limb function measured using 0-10 rating scale for pain at the start of the study and after beginning to wear the orthosis at multiple intervals (24 hours, 1 week, 1 month, 2 months) |
| Key secondary outcome measure(s) |
User satisfaction measured using QUEST 2.0 questionnaire after beginning to wear the orthosis at multiple intervals (24 hours, 1 week, 1 month, 2 months) |
| Completion date | 01/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. The patient must be 18 years or older 2. The patient must have a trigger finger and hyperextension of the proximal interphalangeal joint 3. The patient must be able to use Microsoft Teams or Zoom with their cell phone or computer 4. The patient must be able to read, write and answer the questionnaires |
| Key exclusion criteria | 1. The patient is already wearing an orthosis 2. The patient received a cortisone injection in the last 4 months 3. The patient received surgery for this condition |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/12/2026 |
Locations
Countries of recruitment
- Canada
Study participating centres
Montreal
H2X 0C1
Canada
Trois-Rivières
G9A 5H7
Canada
Trois-Rivières
G8Z 3R8
Canada
Trois-Rivières
G8Z 3R9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Tokiko Hamasaki (tokiko.hamasaki@uqtr.ca) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/11/2025: Study's existence confirmed by the CIUSSS-MCQ.
