Carpal Tunnel SyndromeNCT05597930
New 3D Printed Wrist Orthosis
A study testing Wrist and Thumb orthosis in people with Carpal Tunnel Syndrome and Ulnar Nerve Injury, run by TOPMED at 1 site in Canada.
Trial summary
In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis
- What is being tested?
- Wrist and Thumb orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2022to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 and 70 years old
- Ability to accurately communicate comfort and discomfort,
- Carpal tunnel syndrome, or
- de Quervain's tenosynovitis, or
- Drop hand, or
- Ulnar nerve damage
Show all 9Show fewer
- Rhizarthrosis, or
- Tendinopathy of the thumb
- And/or ulnar gale
Who cannot join
- - Spasticity in the upper limbs
- Paralysis, Insensitivity of the upper limbs
- Neuromuscular pathology affecting the upper limbs
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
TOPMED
Québec, Quebec, G1S1C1
Edith Martin, PhD, 4187801301, emartin@topmed.ca
Marianne Lancelot, 4187801301, mlancelot@topmed.ca
About this study
Official title: Development and Validation of a New Wrist Orthosis by 3D Printing
In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. This project will focus on the development of an orthosis related to carpal tunnel syndrome as well as droopy hand. Among the issues to be addressed in this development proposal, the investigators find: 1) Identification of the best methodology for taking digital impressions; design of an orthosis with the following characteristics: (i) no external attachment system, (ii) spiral design with a thumb ring, (iii) manufacturing by 3D printing and (iv) a cost of less than $150 ;3) Performing technical and clinical trials.
- Conditions
- Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis, Tendinopathy, Thumb, Tenosynovitis de Quervain, Hand Disease
- Being tested
- Wrist and Thumb orthosis
- Medical subject headings
- Carpal Tunnel Syndrome, Tendinopathy, De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist and Thumb orthosisDevice
Custom 3D printed thumb and wrist orthosis
| Study group | Role | What they receive |
|---|---|---|
| Thumb then wrist orthosis | Experimental | Not described Receives: Device: Wrist and Thumb orthosis |
| Wrist then thumb orthosis | Experimental | Not described Receives: Device: Wrist and Thumb orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain during treatment from baseline at day 14
Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)
Measured: Baseline and day 14
Secondary outcomes (14)
Difficulty in donning the orthosis
Yes/No question about having difficulty putting on the orthosis. No unit.
Measured: Each day during 2 weeks of intervention
Comfort
Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.
Measured: Each day during 2 weeks of intervention
Weight satisfaction rating at baseline
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Baseline
Satisfaction on ease of donning
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Baseline
Satisfaction on ease of donning
Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Day 14 of intervention
Satisfaction on ease of doffing
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Baseline
Satisfaction on ease of doffing
Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Day 14 of intervention
Functional disability evaluation of the upper member
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Measured: Baseline
Functional disability evaluation of the upper member
Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
Measured: Day 14 of intervention
Weight satisfaction rating at day 14 of intervention
Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Day 14 of intervention
aesthetic satisfaction rating at day 14 of intervention
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Day 14 of intervention
aesthetic satisfaction rating at baseline
Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Baseline
material quality satisfaction rating at baseline
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Baseline
material quality satisfaction rating at day 14 of intervention
Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Measured: Day 14 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start2 May 2022
- Primary completion24 May 2024 (estimated)
- Study completion24 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Medicus, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597930
- Sponsor's protocol ID
- RD-21-0376
- Status last verified
- Jul 2023
- First submitted
- 20 Oct 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Wrist Orthosis by 3D Printing
- ClinicalTrials.gov ID
- NCT05597930
- Acronym / sponsor ID
- RD-21-0376
- Conditions
- Carpal Tunnel Syndrome, Ulnar Nerve Injury, Rhizarthrosis, Tendinopathy, Thumb, Tenosynovitis de Quervain, Hand Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Medicus, Natural Sciences and Engineering Research Council, Canada
- Study start
- 2 May 2022 (actual)
- Primary completion
- 24 May 2024 (estimated)
- Study completion
- 24 May 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. This project will focus on the development of an orthosis related to carpal tunnel syndrome as well as droopy hand. Among the issues to be addressed in this development proposal, the investigators find: 1) Identification of the best methodology for taking digital impressions; design of an orthosis with the following characteristics: (i) no external attachment system, (ii) spiral design with a thumb ring, (iii) manufacturing by 3D printing and (iv) a cost of less than $150 ;3) Performing technical and clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thumb then wrist orthosis | Experimental | Device: Wrist and Thumb orthosis |
| Wrist then thumb orthosis | Experimental | Device: Wrist and Thumb orthosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be between 18 and 70 years old
- Ability to accurately communicate comfort and discomfort,
- Carpal tunnel syndrome, or
- de Quervain's tenosynovitis, or
- Drop hand, or
Key exclusion criteria (3 listed)
- - Spasticity in the upper limbs
- Paralysis, Insensitivity of the upper limbs
- Neuromuscular pathology affecting the upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist and Thumb orthosisCustom 3D printed thumb and wrist orthosis | Device | Thumb then wrist orthosis, Wrist then thumb orthosis |
Primary outcome
Change in pain during treatment from baseline at day 14
Time frame: Baseline and day 14
Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)
14 secondary outcomes
Difficulty in donning the orthosis
Time frame: Each day during 2 weeks of intervention
Comfort
Time frame: Each day during 2 weeks of intervention
Weight satisfaction rating at baseline
Time frame: Baseline
Satisfaction on ease of donning
Time frame: Baseline
Satisfaction on ease of donning
Time frame: Day 14 of intervention
Satisfaction on ease of doffing
Time frame: Baseline
Satisfaction on ease of doffing
Time frame: Day 14 of intervention
Functional disability evaluation of the upper member
Time frame: Baseline
Functional disability evaluation of the upper member
Time frame: Day 14 of intervention
Weight satisfaction rating at day 14 of intervention
Time frame: Day 14 of intervention
aesthetic satisfaction rating at day 14 of intervention
Time frame: Day 14 of intervention
aesthetic satisfaction rating at baseline
Time frame: Baseline
material quality satisfaction rating at baseline
Time frame: Baseline
material quality satisfaction rating at day 14 of intervention
Time frame: Day 14 of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist and Thumb orthosis in people with Carpal Tunnel Syndrome and Ulnar Nerve Injury, run by TOPMED at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edith Martin, PhD (4187801301, emartin@topmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain during treatment from baseline at day 14 (time frame: Baseline and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.