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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Nocturnal wearing of one of the 2 wrist orthosis kind
Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Bron, France
RECRUITINGCentre Hospitalier Saint Joseph Saint Luc
Lyon, France
RECRUITINGCentre Orthopédique Santy
Lyon, France
RECRUITINGSELARL de Neurologie Bullukian
Lyon, France
RECRUITINGMédipôle Hôpital Mutualiste
Villeurbanne, France
RECRUITINGMeasure 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.
Time frame: Orthosis implementation, 1 month and 3 months after orthosis implementation
Evaluate the failure rate of treatment with nocturnal orthosis
Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Inclusion and 3 months after orthosis implementation
Neurological recovery
For the functional assessment sub-group : performing of an electromyogram
Time frame: Inclusion and 3 months after orthosis implementation
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