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

Carpal Tunnel Syndrome Clinical Trial

— ORTHO-2C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483218
• Other study ID #: ORTHO-2C
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: Philippe SCHIELE, MD
• Phone: 0 478 618 624
• Email: pschiele[@]chsjsl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Nocturnal wrist orthosis wearing
Nocturnal wearing of one of the 2 wrist orthosis kind

Locations

Country	Name	City	State
France	Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon	Bron
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Centre Orthopédique Santy	Lyon
France	SELARL de Neurologie Bullukian	Lyon
France	Médipôle Hôpital Mutualiste	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Muscle strength recovery	For the functional assessment sub-group : measure of muscle strength with a manual dynamometer	Inclusion and 3 months after orthosis implementation
Secondary	Neurological recovery	For the functional assessment sub-group : performing of an electromyogram	Inclusion and 3 months after orthosis implementation