3D-printed wrist orthosis for carpal tunnel syndrome
| ISRCTN | ISRCTN89181201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89181201 |
| Sponsors | Centre Hospitalier de l’Université de Montréal, Université du Québec à Trois-Rivières |
| Funder | Université du Québec à Trois-Rivières |
- Submission date
- 28/11/2025
- Registration date
- 28/11/2025
- Last edited
- 28/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This study is exploring a new way to make orthoses using 3D printing technology. These supports are used to help people with a condition called carpal tunnel syndrome, which causes pain, numbness, and tingling in the hand and fingers due to pressure on the median nerve. 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 a carpal tunnel syndrome 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, if interested, will receive a phone call to verify their eligibility. If eligible, patients will meet with the research assistant, who will scan the affected upper limb. After modeling, the orthosis will be 3D-printed and sent to the patient. They will 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 hand and wrist function thanks to the orthosis. However, wearing it might be uncomfortable and could cause skin irritation or pain due to limited wrist 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?
Université du Québec à Trois-Rivières (UQTR) (Canada)
When is the study starting and how long is it expected to run for?
The study started in June 2025 and is expected to run until December 2026.
Who is funding the study?
Université du Québec à Trois-Rivières (UQTR) (Canada)
Who is the main contact?
Tokiko Hamasaki, 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 (0)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 (0)514-890-8000, ext 11126 |
| stephane.bedwani.chum@ssss.gouv.qc.ca |
Public
850 Boulevard de Maisonneuve Est, 3e-4e étages
Montréal
H2L 4L8
Canada
| Phone | +1 (0)514 623 4531 |
|---|---|
| william.beauchemin@umontreal.ca |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Crossover | |
| Purpose | Treatment | |
| Scientific title | Proof of concept: confection wrist orthoses for carpal tunnel syndrome using 3D printing | |
| Study acronym | 3DP | |
| Study objectives | This project aims to evaluate whether 3D-printed orthosis is acceptable in a clinical setting, both for professionals and for patients with carpal tunnel syndrome. This technology, which is still rarely used in this field, could offer practical and clinical advantages over traditional methods. | |
| Ethics approval(s) |
Approved 13/11/2025, 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 (0)819 372-3133, poste 32303; 04ethiqueciusssmcq@ssss.gouv.qc.ca), ref: MP-29-2026-896, 1026 | |
| Health condition(s) or problem(s) studied | Carpal tunnel syndrome of the wrist | |
| 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) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| 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 carpal tunnel syndrome of the wrist 3. 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 | 05/12/2025 |
| Date of final enrolment | 01/10/2026 |
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 | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
28/11/2025: Study's existence confirmed by the Comité d'éthique de la recherche du CIUSSS de la Mauricie-et-du-Centre-du-Québec.
