Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP) (ORTHO-2C)
Primary Purpose
Carpal Tunnel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nocturnal wrist orthosis wearing
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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
Sites / Locations
- Centre Hospitalier Saint Joseph Saint LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
wrist orthosis
wrist-hand-finger orthosis
Arm Description
group benefiting from an orthosis that supports the wrist by covering the palm of the hand only
group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluate the failure rate of treatment with nocturnal orthosis
Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments
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.
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.
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.
Muscle strength recovery
For the functional assessment sub-group : measure of muscle strength with a manual dynamometer
Neurological recovery
For the functional assessment sub-group : performing of an electromyogram
Full Information
NCT ID
NCT05483218
First Posted
July 5, 2022
Last Updated
March 7, 2023
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT05483218
Brief Title
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
Acronym
ORTHO-2C
Official Title
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wrist orthosis
Arm Type
Experimental
Arm Description
group benefiting from an orthosis that supports the wrist by covering the palm of the hand only
Arm Title
wrist-hand-finger orthosis
Arm Type
Experimental
Arm Description
group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers
Intervention Type
Device
Intervention Name(s)
Nocturnal wrist orthosis wearing
Intervention Description
Nocturnal wearing of one of the 2 wrist orthosis kind
Primary Outcome Measure Information:
Title
Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
Description
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
Secondary Outcome Measure Information:
Title
Evaluate the failure rate of treatment with nocturnal orthosis
Description
Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments
Time Frame
3 months after orthosis implementation
Title
Compare the patient's compliance with wearing the 2 types of nocturnal orthosis
Description
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
Title
Compare the comfort of the 2 types of nocturnal orthosis
Description
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
Title
Evaluate the impact of the precocity of the conservative treatment on its effectiveness
Description
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
Title
Muscle strength recovery
Description
For the functional assessment sub-group : measure of muscle strength with a manual dynamometer
Time Frame
Inclusion and 3 months after orthosis implementation
Title
Neurological recovery
Description
For the functional assessment sub-group : performing of an electromyogram
Time Frame
Inclusion and 3 months after orthosis implementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe SCHIELE, MD
Phone
0 478 618 624
Ext
+33
Email
pschiele@chsjsl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane RIO, M.
Phone
0 478 61 8 216
Ext
+33
Email
srio@chsjsl.fr
Facility Information:
Facility Name
Centre Hospitalier Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Schiele, MD
Phone
478 618 216
Ext
+33
Email
pschiele@chsjsl.fr
First Name & Middle Initial & Last Name & Degree
Stéphane Rio
Phone
478 618 216
Ext
+33
Email
srio@chsjsl.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
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