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

NCT05483218 | Recruiting

• 1 other identifier: ORTHO-2C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluate the failure rate of treatment with nocturnal orthosis

  3 months after orthosis implementation

• Compare the patient's compliance with wearing the 2 types of nocturnal orthosis

  1 month and 3 months after orthosis implementation

• Compare the comfort of the 2 types of nocturnal orthosis

  1 month and 3 months after orthosis implementation

• Evaluate the impact of the precocity of the conservative treatment on its effectiveness

  1 month and 3 months after orthosis implementation

• Muscle strength recovery

  Inclusion and 3 months after orthosis implementation

Study Arms (2)

wrist orthosis

EXPERIMENTAL

group benefiting from an orthosis that supports the wrist by covering the palm of the hand only

Device: Nocturnal wrist orthosis wearing

wrist-hand-finger orthosis

EXPERIMENTAL

group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers

Device: Nocturnal wrist orthosis wearing

Interventions

Nocturnal wrist orthosis wearing DEVICE

Nocturnal wearing of one of the 2 wrist orthosis kind

wrist orthosis; wrist-hand-finger orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (5)

Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

RECRUITING

Centre Orthopédique Santy

Lyon, 69008, France

RECRUITING

SELARL de Neurologie Bullukian

Lyon, 69008, France

RECRUITING

Médipôle Hôpital Mutualiste

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Philippe SCHIELE, MD

CONTACT

0 478 618 624; pschiele@chsjsl.fr

Stéphane RIO, M.

CONTACT

0 478 61 8 216; srio@chsjsl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: August 2, 2022
• Study Start: February 27, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

FR (5)