ORTHO-2C: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: wrist orthosis group benefiting from an orthosis that supports the wrist by covering the palm of the hand only |
Device: Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind
|
| Experimental: wrist-hand-finger orthosis group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers |
Device: Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind
|
Outcome Measures
Primary Outcome Measures
- Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses [Orthosis implementation, 1 month and 3 months after orthosis implementation]
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.
Secondary Outcome Measures
- Evaluate the failure rate of treatment with nocturnal orthosis [3 months after orthosis implementation]
Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments
- Compare the patient's compliance with wearing the 2 types of nocturnal orthosis [1 month and 3 months after orthosis implementation]
Score of "numerical scale of orthosis wearing duration" : from "never" to "every night". Higher score means better outcome.
- Compare the comfort of the 2 types of nocturnal orthosis [1 month and 3 months after orthosis implementation]
Score of "numerical scale of comfort" : from "1" (very uncomfortable) to "5" (perfectly comfortable). Higher score means better outcome.
- Evaluate the impact of the precocity of the conservative treatment on its effectiveness [1 month and 3 months after orthosis implementation]
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.
- Muscle strength recovery [Inclusion and 3 months after orthosis implementation]
For the functional assessment sub-group : measure of muscle strength with a manual dynamometer
- Neurological recovery [Inclusion and 3 months after orthosis implementation]
For the functional assessment sub-group : performing of an electromyogram
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORTHO-2C