Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05951218
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-07-09', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline pain during palpation at 5 minutes', 'timeFrame': '5 minutes before and 5 minutes after the treatment session', 'description': 'change in pain will be assess with a 0 to 4 scale before and after techniques on each boxes. Pain in relation to a TP will be compared between patients from placebo arm and intervention arm'}], 'secondaryOutcomes': [{'measure': 'Change from baseline echogenicity at 5 minutes', 'timeFrame': '5 minutes before and 5 minutes after the treatment session', 'description': 'Echogenicity will be assess with a binary outcome (0 for normal echogenicity and 1 for hypoechogenicity) before and after techniques on each boxes. Echogenicity in relation to a TP will be compared between patients from placebo arm and intervention arm'}]}, 'oversightModule': {'oversightHasDmc': False, '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".\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. All included osteopaths will receive a formation to test and treat with the same approach and the same strength during all stages.\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 echogenicity of every box and will be blinded to the prior results.\n\nEvery patient with a TP diagnosed by the first osteopath, will be randomised into two groups (inhibition of trigger point technique with a long standing press on the TP, placebo technique with four light touch techniques on both shoulders, sternum and rachis).\n\nThe second osteopath will evaluate the same boxes and will be blinded to the randomisation process. At each step of palpation, a pain assessment will be carried out at each box.\n\nThe ultrasound technician will evaluate an other time the echogenicity of every box and will be blinded to the prior results, and randomisation.\n\nA blinded statistician will evaluate the efficacy of inhibition technique on echogenicity and patients\' pain during the tests.\n\nThe protocol has been approved by a french ethic committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 50 years\n* be affiliated to a social security system or benefit from such a system.\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women\n* adults under guardianship\n* patients under protection\n* history of tegumentary or muscular damage in the area concerned\n* wish to stop the study'}, 'identificationModule': {'nctId': 'NCT05951218', 'briefTitle': "Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain", '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-2'}, 'secondaryIdInfos': [{'id': '2023-A00637-38', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'inhibition technique', 'description': 'In the first group, patients will receive inhibition treatment of the TP.', 'interventionNames': ['Other: inhibition technique']}, {'type': 'SHAM_COMPARATOR', 'label': 'placebo', 'description': 'The second group will receive a placebo treatment.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'inhibition technique', 'type': 'OTHER', 'description': 'Inhibition treatment consists of applying progressive pressure with the finger until resistance is felt. The patient should feel discomfort but not pain. They should stop when they consider that the trigger point has been sufficiently relaxed. All the techniques should last less than 5 minutes. Osteopaths will be trained to have a close strength during techniques. The number of Newton that will be apply will be decided during training with the investigator', 'armGroupLabels': ['inhibition technique']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'The osteopath will perform a light touch on 4 areas for 30 seconds each time. The trigger point area must be lightly touched, followed by the upper part of the pectoralis major, the elbow and finally the anterior part of the opposite glenohumeral region.\n\nOsteopaths will be trained to have a close strength during techniques. The number of Newton that will be apply will be decided during training with the investigator with a palpatory pressure measurement tool. A proposition of 1N will be proposed to have a very light touch, without activating the C-tactile sensors.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maxime Salmon, MSc', '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'}}}}