Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT05785650
Status:
UNKNOWN
Last Update Posted:
2023-07-20
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity of osteopathic tests', 'timeFrame': 'at day 1', 'description': 'to compare osteopath TP detection to ultrasound echogenicity'}], 'secondaryOutcomes': [{'measure': 'Inter examiner reproductibility of TP detection', 'timeFrame': 'at day 1', 'description': "using Cohen's kappa weighted by the distance between the TPs found. Quadratic weighting will be used."}, {'measure': 'camparison of pain reported by patient with TP detection by osteopath', 'timeFrame': 'at day 1', 'description': 'using a student test between pain means in areas with and without TP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trigger point', 'osteopathic palpation', 'ultrasound'], 'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'Trigger points (TP) are described as "hard, palpable nodules located within the taut bands of skeletal muscle" (Bardoni, 2022).\n\nThe aim of this study is to evaluate the reproductibility of palpation of TP between osteopaths and to compare this perception to ultrasound measures of echogenicity.\n\nMethod:\n\nA sample of 61 patients will be included in the study. An osteopath will determine the eligibility of the study. The supraclavicular area will be mark every 2 cm to establish a grid for all evaluations.\n\nFirst an osteopath will evaluate with palpation the presence of TP at every box of the grid.\n\nA second osteopath will evaluate the same boxes and will be blinded to the result of the first osteopath.\n\nAt each step of palpation, a pain assessment will be carried out at each box. Then, the ultrasound technician will evaluate the echogeneicity of every box and will be blinded to the prior results.\n\nThe protocol will be approve by a french ethic committee.', 'detailedDescription': "sensitivity and specificity of osteopathic tests will be conducted in comparaison to echograph results (a binary outcomes assessing the presence of an hypoechogenicity).\n\nThe reproductibility of osteopaths' tests will be be calculated using Cohen's kappa weighted by the distance between the TPs found.\n\nFinally, the pain reported by patients on areas with a TP defined by the osteopath, and the pain reported by patients on areas without a TP defined by the osteopath will be compared using a student test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There will be 61 healthy adults The population studied will be heterogeneous with or without shoulder pain Recruitment will be based on students or patients of IdHEO Nantes osteopathy clinic on a voluntary basis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 to 50 years old),\n* affiliation to a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* pregnant and breastfeeding women,\n* adults under guardianship and protected patients.\n* History of integumentary or muscular involvement in the area of interest\n* Allergic reaction\n* wish to stop the study'}, 'identificationModule': {'nctId': 'NCT05785650', 'briefTitle': "Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation", 'organization': {'class': 'OTHER', 'fullName': 'Institut des Hautes Etudes Osteopathiques de Nantes'}, 'officialTitle': "Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation", 'orgStudyIdInfo': {'id': 'TRIGGOSTEO-1'}, 'secondaryIdInfos': [{'id': '2023-A00637-38', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et produits de santé'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'osteopathic palpation', 'type': 'DIAGNOSTIC_TEST', 'description': 'comparaison of ultrasound caracteristics of areas with ad without TP'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maxime Salmon', 'role': 'CONTACT', 'email': 'msalmon@idheo.com', 'phone': '+332 28 07 29 28'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'on demand to m. salmon'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut des Hautes Etudes Osteopathiques de Nantes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}