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

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ClinicalTrials.gov Identifier: NCT05483218
Recruitment Status : Recruiting
First Posted : August 2, 2022
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study Description
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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
Carpal Tunnel Syndrome Device: Nocturnal wrist orthosis wearing Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
Actual Study Start Date : February 27, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses [ Time Frame: 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 :
  1. Evaluate the failure rate of treatment with nocturnal orthosis [ Time Frame: 3 months after orthosis implementation ]
    Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments

  2. Compare the patient's compliance with wearing the 2 types of nocturnal orthosis [ Time Frame: 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.

  3. Compare the comfort of the 2 types of nocturnal orthosis [ Time Frame: 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.

  4. Evaluate the impact of the precocity of the conservative treatment on its effectiveness [ Time Frame: 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.

  5. Muscle strength recovery [ Time Frame: Inclusion and 3 months after orthosis implementation ]
    For the functional assessment sub-group : measure of muscle strength with a manual dynamometer

  6. Neurological recovery [ Time Frame: Inclusion and 3 months after orthosis implementation ]
    For the functional assessment sub-group : performing of an electromyogram


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05483218


Contacts
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Contact: Philippe SCHIELE, MD 0 478 618 624 ext +33 pschiele@chsjsl.fr
Contact: Stéphane RIO, M. 0 478 61 8 216 ext +33 srio@chsjsl.fr

Locations
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France
Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Françoise BOUHOUR, MD    472 118 063 ext +33    françoise.bouhour@chu-lyon.fr   
Centre Hospitalier Saint Joseph Saint Luc Recruiting
Lyon, France, 69007
Contact: Philippe Schiele, MD    478 618 216 ext +33    pschiele@chsjsl.fr   
Contact: Stéphane Rio    478 618 216 ext +33    srio@chsjsl.fr   
Centre Orthopédique Santy Recruiting
Lyon, France, 69008
Contact: Jordane SAUNIER, MD    437 530 038 ext +33    sec.rhumato@orthosanty.fr   
SELARL de Neurologie Bullukian Recruiting
Lyon, France, 69008
Contact: Nadia VANDENBERGHE, MD    472 340 690 ext +33    nvandenberghe@orange.fr   
Médipôle Hôpital Mutualiste Recruiting
Villeurbanne, France, 69100
Contact: Aurore BRAQUET, MD    481 655 296 ext +33    a.braquet@resamut.fr   
Sponsors and Collaborators
Centre Hospitalier Saint Joseph Saint Luc de Lyon
More Information
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Responsible Party: Centre Hospitalier Saint Joseph Saint Luc de Lyon
ClinicalTrials.gov Identifier: NCT05483218    
Other Study ID Numbers: ORTHO-2C
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries