Carpal Tunnel SyndromeORTHO-2CNCT05483218
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
A study testing Nocturnal wrist orthosis wearing in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites in France.
Trial summary
This study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nocturnal wrist orthosis wearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- 27 Feb 2023to Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with unilateral or bilateral, idiopathic or secondary carpal tunnel syndrome, without surgical indication (EMG with myelin sensory signs without axonal involvement)
- signed consent
- Affiliation to social security
Who cannot join
- Patients with carpal tunnel syndrome with severity criteria
- Patient refusal
- Patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment
- Presence of skin lesion in the area of the orthosis
- Current participation in another research protocol involving the human person
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Bron, 69500
Françoise BOUHOUR, MD, 472 118 063 ext. +33, françoise.bouhour@chu-lyon.fr
- Recruiting
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Philippe Schiele, MD, 478 618 216 ext. +33, pschiele@chsjsl.fr
Stéphane Rio, 478 618 216 ext. +33, srio@chsjsl.fr
- Recruiting
Centre Orthopédique Santy
Lyon, 69008
Jordane SAUNIER, MD, 437 530 038 ext. +33, sec.rhumato@orthosanty.fr
- Recruiting
SELARL de Neurologie Bullukian
Lyon, 69008
Nadia VANDENBERGHE, MD, 472 340 690 ext. +33, nvandenberghe@orange.fr
- Recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
Aurore BRAQUET, MD, 481 655 296 ext. +33, a.braquet@resamut.fr
About this study
Official title: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
This study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other.
It will also be possible to assess their comfort and compliance as well as the impact of wearing them on neurological and muscular recovery (functional assessment).
Read the detailed description
After selection of patients suffering from carpal tunnel syndrome during consultation visits, the study will be explained to them, an information sheet and a consent form will be given to them.
A subgroup of patients who have undergone a diagnostic electromyogram at the study center (defined as a functional assessment subgroup) will be randomized independently of the other participants (2 randomization lists will be generated).
The randomization will be done on 2 groups: one benefiting from a wrist orthosis called simple rest, and the other from a wrist-hand-finger orthosis called global rest.
An appointment for making the orthosis will be fixed with the manufacturer within one month of inclusion.
The follow-up will then be done by 2 telephone collection visits at 1 month then at 2 months of the implementation of the device then by a last visit at 3 months consisting in a consultation for the functional assessment subgroup and a phone call for the others.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Nocturnal wrist orthosis wearing
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal wrist orthosis wearingDevice
Nocturnal wearing of one of the 2 wrist orthosis kind
| Study group | Role | What they receive |
|---|---|---|
| wrist orthosis | Experimental | group benefiting from an orthosis that supports the wrist by covering the palm of the hand only Receives: Device: Nocturnal wrist orthosis wearing |
| wrist-hand-finger orthosis | Experimental | group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers Receives: Device: Nocturnal wrist orthosis wearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
Score of Boston Carpal Tunnel Syndrome Questionnaire : SEVERITY SCALE OF SYMPTOMS (11 ITEMS): score from 1 to 5 (each item) + FUNCTIONAL EVALUATION SCALE (8 ITEMS): score from 1 to 5 (each item). Higher score means worse outcome.
Measured: Orthosis implementation, 1 month and 3 months after orthosis implementation
Secondary outcomes (6)
Evaluate the failure rate of treatment with nocturnal orthosis
Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments
Measured: 3 months after orthosis implementation
Compare the patient's compliance with wearing the 2 types of nocturnal orthosis
Score of "numerical scale of orthosis wearing duration" : from "never" to "every night". Higher score means better outcome.
Measured: 1 month and 3 months after orthosis implementation
Compare the comfort of the 2 types of nocturnal orthosis
Score of "numerical scale of comfort" : from "1" (very uncomfortable) to "5" (perfectly comfortable). Higher score means better outcome.
Measured: 1 month and 3 months after orthosis implementation
Evaluate the impact of the precocity of the conservative treatment on its effectiveness
Score of Boston Carpal Tunnel Syndrome Questionnaire : SEVERITY SCALE OF SYMPTOMS (11 ITEMS): score from 1 to 5 (each item) + FUNCTIONAL EVALUATION SCALE (8 ITEMS): score from 1 to 5 (each item). Higher score means worse outcome.
Measured: 1 month and 3 months after orthosis implementation
Muscle strength recovery
For the functional assessment sub-group : measure of muscle strength with a manual dynamometer
Measured: Inclusion and 3 months after orthosis implementation
Neurological recovery
For the functional assessment sub-group : performing of an electromyogram
Measured: Inclusion and 3 months after orthosis implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start27 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483218
- Sponsor's protocol ID
- ORTHO-2C
- Acronym
- ORTHO-2C
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05483218
- Acronym / sponsor ID
- ORTHO-2C / ORTHO-2C
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 2 Aug 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.
This study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other.
It will also be possible to assess their comfort and compliance as well as the impact of wearing them on neurological and muscular recovery (functional assessment).
Detailed description
After selection of patients suffering from carpal tunnel syndrome during consultation visits, the study will be explained to them, an information sheet and a consent form will be given to them.
A subgroup of patients who have undergone a diagnostic electromyogram at the study center (defined as a functional assessment subgroup) will be randomized independently of the other participants (2 randomization lists will be generated).
The randomization will be done on 2 groups: one benefiting from a wrist orthosis called simple rest, and the other from a wrist-hand-finger orthosis called global rest.
An appointment for making the orthosis will be fixed with the manufacturer within one month of inclusion.
The follow-up will then be done by 2 telephone collection visits at 1 month then at 2 months of the implementation of the device then by a last visit at 3 months consisting in a consultation for the functional assessment subgroup and a phone call for the others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wrist orthosis | Experimental | Device: Nocturnal wrist orthosis wearinggroup benefiting from an orthosis that supports the wrist by covering the palm of the hand only |
| wrist-hand-finger orthosis | Experimental | Device: Nocturnal wrist orthosis wearinggroup benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age with unilateral or bilateral, idiopathic or secondary carpal tunnel syndrome, without surgical indication (EMG with myelin sensory signs without axonal involvement)
- signed consent
- Affiliation to social security
Key exclusion criteria (5 listed)
- Patients with carpal tunnel syndrome with severity criteria
- Patient refusal
- Patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment
- Presence of skin lesion in the area of the orthosis
- Current participation in another research protocol involving the human person
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 |
|---|---|---|
| Nocturnal wrist orthosis wearingNocturnal wearing of one of the 2 wrist orthosis kind | Device | wrist orthosis, wrist-hand-finger orthosis |
Primary outcome
Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
Time frame: Orthosis implementation, 1 month and 3 months after orthosis implementation
Score of Boston Carpal Tunnel Syndrome Questionnaire : SEVERITY SCALE OF SYMPTOMS (11 ITEMS): score from 1 to 5 (each item) + FUNCTIONAL EVALUATION SCALE (8 ITEMS): score from 1 to 5 (each item). Higher score means worse outcome.
6 secondary outcomes
Evaluate the failure rate of treatment with nocturnal orthosis
Time frame: 3 months after orthosis implementation
Compare the patient's compliance with wearing the 2 types of nocturnal orthosis
Time frame: 1 month and 3 months after orthosis implementation
Compare the comfort of the 2 types of nocturnal orthosis
Time frame: 1 month and 3 months after orthosis implementation
Evaluate the impact of the precocity of the conservative treatment on its effectiveness
Time frame: 1 month and 3 months after orthosis implementation
Muscle strength recovery
Time frame: Inclusion and 3 months after orthosis implementation
Neurological recovery
Time frame: Inclusion and 3 months after orthosis implementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocturnal wrist orthosis wearing in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites in France.
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 3 inclusion and 5 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 Philippe SCHIELE, MD (0 478 618 624 ext. +33, pschiele@chsjsl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses (time frame: Orthosis implementation, 1 month and 3 months after orthosis implementation). 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 19 Mar 2024.