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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Device: Nocturnal wrist orthosis wearing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wrist orthosis<br>group benefiting from an orthosis that supports the wrist by covering the palm of the hand only | Device: Nocturnal wrist orthosis wearing<br>* Nocturnal wearing of one of the 2 wrist orthosis kind<br>|
| Experimental: wrist-hand-finger orthosis<br>group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers | Device: Nocturnal wrist orthosis wearing<br>* Nocturnal wearing of one of the 2 wrist orthosis kind<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Orthosis implementation, 1 month and 3 months after orthosis implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the failure rate of treatment with nocturnal orthosis | Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments | 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. | 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. | 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. | 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 | Inclusion and 3 months after orthosis implementation | 
| Neurological recovery | For the functional assessment sub-group : performing of an electromyogram | Inclusion and 3 months after orthosis implementation |