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

Last updated: March 18, 2024
Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carpal Tunnel Syndrome

Treatment

Nocturnal wrist orthosis wearing

Clinical Study ID

NCT05483218
ORTHO-2C
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age with unilateral or bilateral, idiopathic or secondarycarpal tunnel syndrome, without surgical indication (EMG with myelin sensory signswithout axonal involvement)
  • signed consent
  • Affiliation to social security

Exclusion

Exclusion Criteria:

  • Patients with carpal tunnel syndrome with severity criteria
  • Patient refusal
  • Patient with disorders (psychological, behavioral) that may lead to poor compliancewith the study treatment
  • Presence of skin lesion in the area of the orthosis
  • Current participation in another research protocol involving the human person

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Nocturnal wrist orthosis wearing
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

    Bron, 69500
    France

    Active - Recruiting

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69007
    France

    Active - Recruiting

  • Centre Orthopédique Santy

    Lyon, 69008
    France

    Active - Recruiting

  • SELARL de Neurologie Bullukian

    Lyon, 69008
    France

    Active - Recruiting

  • Médipôle Hôpital Mutualiste

    Villeurbanne, 69100
    France

    Active - Recruiting

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