Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
NCT ID: NCT05483218
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-27
2025-02-28
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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wrist orthosis
group benefiting from an orthosis that supports the wrist by covering the palm of the hand only
Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind
wrist-hand-finger orthosis
group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers
Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind
Interventions
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Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind
Eligibility Criteria
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Inclusion Criteria
* signed consent
* Affiliation to social security
Exclusion 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Saint Joseph Saint Luc de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Bron, , France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, , France
Centre Orthopédique Santy
Lyon, , France
SELARL de Neurologie Bullukian
Lyon, , France
Médipôle Hôpital Mutualiste
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORTHO-2C
Identifier Type: -
Identifier Source: org_study_id
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