Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP) (ORTHO-2C)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Device: Nocturnal wrist orthosis wearing

Study type: Interventional

Funder types: Other

Identifiers

NCT05483218

ORTHO-2C

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

wrist orthosis

Experimental group

Description:

group benefiting from an orthosis that supports the wrist by covering the palm of the hand only

Treatment:

Device: Nocturnal wrist orthosis wearing

wrist-hand-finger orthosis

Experimental group

Description:

group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers

Treatment:

Device: Nocturnal wrist orthosis wearing