Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05483218
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2022-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses', 'timeFrame': 'Orthosis implementation, 1 month and 3 months after orthosis implementation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the failure rate of treatment with nocturnal orthosis', 'timeFrame': '3 months after orthosis implementation', 'description': 'Need for surgery / infiltration / initiation or increase of anti-inflammatory treatments'}, {'measure': "Compare the patient's compliance with wearing the 2 types of nocturnal orthosis", 'timeFrame': '1 month and 3 months after orthosis implementation', 'description': 'Score of "numerical scale of orthosis wearing duration" : from "never" to "every night". Higher score means better outcome.'}, {'measure': 'Compare the comfort of the 2 types of nocturnal orthosis', 'timeFrame': '1 month and 3 months after orthosis implementation', 'description': 'Score of "numerical scale of comfort" : from "1" (very uncomfortable) to "5" (perfectly comfortable). Higher score means better outcome.'}, {'measure': 'Evaluate the impact of the precocity of the conservative treatment on its effectiveness', 'timeFrame': '1 month and 3 months after orthosis implementation', 'description': '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.'}, {'measure': 'Muscle strength recovery', 'timeFrame': 'Inclusion and 3 months after orthosis implementation', 'description': 'For the functional assessment sub-group : measure of muscle strength with a manual dynamometer'}, {'measure': 'Neurological recovery', 'timeFrame': 'Inclusion and 3 months after orthosis implementation', 'description': 'For the functional assessment sub-group : performing of an electromyogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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).', 'detailedDescription': '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.\n\nA 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).\n\nThe 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.\n\nAn appointment for making the orthosis will be fixed with the manufacturer within one month of inclusion.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* signed consent\n* Affiliation to social security\n\nExclusion Criteria:\n\n* Patients with carpal tunnel syndrome with severity criteria\n* Patient refusal\n* Patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment\n* Presence of skin lesion in the area of the orthosis\n* Current participation in another research protocol involving the human person'}, 'identificationModule': {'nctId': 'NCT05483218', 'acronym': 'ORTHO-2C', 'briefTitle': 'Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome (AMYLYONCARP)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Saint Joseph Saint Luc de Lyon'}, 'officialTitle': 'Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'ORTHO-2C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wrist orthosis', 'description': 'group benefiting from an orthosis that supports the wrist by covering the palm of the hand only', 'interventionNames': ['Device: Nocturnal wrist orthosis wearing']}, {'type': 'EXPERIMENTAL', 'label': 'wrist-hand-finger orthosis', 'description': 'group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers', 'interventionNames': ['Device: Nocturnal wrist orthosis wearing']}], 'interventions': [{'name': 'Nocturnal wrist orthosis wearing', 'type': 'DEVICE', 'description': 'Nocturnal wearing of one of the 2 wrist orthosis kind', 'armGroupLabels': ['wrist orthosis', 'wrist-hand-finger orthosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Françoise BOUHOUR, MD', 'role': 'CONTACT', 'email': 'françoise.bouhour@chu-lyon.fr', 'phone': '472 118 063', 'phoneExt': '+33'}], 'facility': 'Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69007', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Schiele, MD', 'role': 'CONTACT', 'email': 'pschiele@chsjsl.fr', 'phone': '478 618 216', 'phoneExt': '+33'}, {'name': 'Stéphane Rio', 'role': 'CONTACT', 'email': 'srio@chsjsl.fr', 'phone': '478 618 216', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Saint Joseph Saint Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jordane SAUNIER, MD', 'role': 'CONTACT', 'email': 'sec.rhumato@orthosanty.fr', 'phone': '437 530 038', 'phoneExt': '+33'}], 'facility': 'Centre Orthopédique Santy', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadia VANDENBERGHE, MD', 'role': 'CONTACT', 'email': 'nvandenberghe@orange.fr', 'phone': '472 340 690', 'phoneExt': '+33'}], 'facility': 'SELARL de Neurologie Bullukian', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69100', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurore BRAQUET, MD', 'role': 'CONTACT', 'email': 'a.braquet@resamut.fr', 'phone': '481 655 296', 'phoneExt': '+33'}], 'facility': 'Médipôle Hôpital Mutualiste', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'Philippe SCHIELE, MD', 'role': 'CONTACT', 'email': 'pschiele@chsjsl.fr', 'phone': '0 478 618 624', 'phoneExt': '+33'}, {'name': 'Stéphane RIO, M.', 'role': 'CONTACT', 'email': 'srio@chsjsl.fr', 'phone': '0 478 61 8 216', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Saint Joseph Saint Luc de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}