Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP) (ORTHO-2C)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Nocturnal wrist orthosis wearing

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe SCHIELE, MD; Phone Number: +33 0 478 618 624; Email: pschiele@chsjsl.fr
• Study Contact Backup: Name: Stéphane RIO, M.; Phone Number: +33 0 478 61 8 216; Email: srio@chsjsl.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
    • Contact: Françoise BOUHOUR, MD; Phone Number: +33 472 118 063; Email: françoise.bouhour@chu-lyon.fr
  • Lyon, France, 69007
    • Recruiting
    • Centre Hospitalier Saint Joseph Saint Luc
    • Contact: Philippe Schiele, MD; Phone Number: +33 478 618 216; Email: pschiele@chsjsl.fr
    • Contact: Stéphane Rio; Phone Number: +33 478 618 216; Email: srio@chsjsl.fr
  • Lyon, France, 69008
    • Recruiting
    • Centre Orthopedique Santy
    • Contact: Jordane SAUNIER, MD; Phone Number: +33 437 530 038; Email: sec.rhumato@orthosanty.fr
  • Lyon, France, 69008
    • Recruiting
    • SELARL de Neurologie Bullukian
    • Contact: Nadia VANDENBERGHE, MD; Phone Number: +33 472 340 690; Email: nvandenberghe@orange.fr
  • Villeurbanne, France, 69100
    • Recruiting
    • Medipole Hopital Mutualiste
    • Contact: Aurore BRAQUET, MD; Phone Number: +33 481 655 296; Email: a.braquet@resamut.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: ORTHO-2C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No