Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-01 @ 8:15 PM
Study NCT ID:
NCT05892250
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Humeral Centering Exercises in Subacromial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], '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'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-05-27', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subacromial space dimensions', 'timeFrame': 'baseline', 'description': 'Ultrasonography measure of coracohumeral and acromiohumeral distances'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'baseline', 'description': "Participants' self-reported pain intensity during activities of daily living, night pain, and pain at rest"}, {'measure': 'Range of motion', 'timeFrame': 'baseline', 'description': 'Active and passive range of motion in coronal, sagital and transverse planes'}, {'measure': 'Muscular endurance', 'timeFrame': 'baseline', 'description': 'Time (in seconds) it takes for the participant to become fatigued when performing repetitive movements with the upper extremity in the frontal plane'}, {'measure': 'Muscular endurance', 'timeFrame': 'baseline', 'description': 'Number of repetitions performed by the subject until fatigue occurs when performing repetitive movements with the upper limb in the frontal plane'}, {'measure': 'Shoulder Pain and Disability Index', 'timeFrame': 'baseline', 'description': 'Measures the percentage of disability in a person, with a minimum value of 0 (best) and a maximum of 100 percent.(worse)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain', 'Shoulder Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Subacromial pain syndrome is one of the most common musculoskeletal health conditions, causing decreased of range of motion, loss of muscle strength and disability in the shoulder region. It has been proposed that dynamic humeral centering exercises could contribute to overcome these disorders, through the modification of the dimensions of the subacromial space, however, there is no consensus on its effectiveness nor direct variables that account for its efficacy. Therefore, the aim of this research is to determine the effects of a dynamic humeral centering exercise program on the functionality and disability of patients with subacromial pain syndrome.The effects of the dynamic humeral head exercises program, as well as the objective description of factors and variables associated with subacromial pain syndrome, will also allow rehabilitation science professionals to aim their interventions according to the knowledge of direct variables, which will allow objective follow-up of interventions on subacromial pain syndrome diagnosed patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Older than 18 years old and less than 60 years old.\n* Pain in the lateral and upper arm region for more than two weeks of evolution.\n* At least three positive tests in the following: Neer's impingement sign, Hawkins-Kennedy impingement sign, Pattes' maneuver, Jobe's test or painful arch.\n\nExclusion Criteria:\n\n* Having any of the following diagnoses: frozen shoulder, shoulder girdle joint instability, cancer, glenohumeral arthrosis, symptomatic acromioclavicular arthritis, glenohumeral arthritis, rheumatoid arthritis, or fibromyalgia.\n* Cervical or thoracic pain.\n* Fracture or surgery in the shoulder region or in the last 6 months."}, 'identificationModule': {'nctId': 'NCT05892250', 'briefTitle': 'Dynamic Humeral Centering Exercises in Subacromial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antofagasta'}, 'officialTitle': 'Effects of Dynamic Humeral Centering Exercises on Functionality and Disability in Subacromial Pain Syndrome', 'orgStudyIdInfo': {'id': '17798315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Intervention will consist of a conventional physical therapy treatment program that includes manual therapy techniques and exercise', 'interventionNames': ['Behavioral: Conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Intervention will consist of a conventional physical therapy treatment program that includes manual therapy techniques and exercise plus Dynamic Humeral Centering exercises', 'interventionNames': ['Behavioral: Conventional physical therapy + Dynamic Humeral Centering exercises']}], 'interventions': [{'name': 'Conventional physical therapy', 'type': 'BEHAVIORAL', 'description': 'Manual techniques and therapeutic exercise', 'armGroupLabels': ['Control group']}, {'name': 'Conventional physical therapy + Dynamic Humeral Centering exercises', 'type': 'BEHAVIORAL', 'description': 'Manual techniques and therapeutic exercise and active dynamic humeral centering exercises', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1240000', 'city': 'Antofagasta', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Juan Guerrero, MSc', 'role': 'CONTACT', 'email': 'juan.guerrero@uantof.cl', 'phone': '56957601527', 'phoneExt': '7067'}], 'facility': 'Universidad de Antofagasta', 'geoPoint': {'lat': -23.65094, 'lon': -70.39752}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available once there are publications associated with the clinical trial. These data will be available for 4 years.', 'ipdSharing': 'YES', 'description': 'The information will be provided to other researchers upon request to the principal investigator of the project.', 'accessCriteria': 'By e-mail request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antofagasta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juan Guerrero Henriquez', 'investigatorAffiliation': 'Universidad de Antofagasta'}}}}