Clinical trial NCT05483218: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
Official title: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
timeFrame: Orthosis implementation, 1 month and 3 months after orthosis implementation
Secondary outcomes:
measure: Evaluate the failure rate of treatment with nocturnal orthosis
timeFrame: 3 months after orthosis implementation
measure: Compare the patient's compliance with wearing the 2 types of nocturnal orthosis
timeFrame: 1 month and 3 months after orthosis implementation
measure: Compare the comfort of the 2 types of nocturnal orthosis
timeFrame: 1 month and 3 months after orthosis implementation
measure: Evaluate the impact of the precocity of the conservative treatment on its effectiveness
timeFrame: 1 month and 3 months after orthosis implementation
measure: Muscle strength recovery
timeFrame: Inclusion and 3 months after orthosis implementation
measure: Neurological recovery
timeFrame: Inclusion and 3 months after orthosis implementation
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Lyon
country: France
facility: Centre Orthopédique Santy
city: Lyon
country: France
facility: SELARL de Neurologie Bullukian
city: Villeurbanne
country: France
facility: Médipôle Hôpital Mutualiste
Study officials:
References: