Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-14 @ 3:59 AM
Study NCT ID:
NCT03568006
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'It is not possible to mask physiotherapists and patients, so the only masking will be for researchers and evaluators'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (2 weeks).', 'description': '10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain'}], 'secondaryOutcomes': [{'measure': 'Active range of motion', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (2 weeks).', 'description': 'Measurement of active range of motion for the different shoulder movements (abduction from 0 to 150º, flexion from 0 to 180º, extension from 0 to 60º, lateral rotation from 0 to 90º, internal rotation from o to 70º)'}, {'measure': 'Constant Score', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (2 weeks).', 'description': 'Scale to measure shoulder function, ranging from 0 to 100. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\\[1\\] The Constant score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subacromial impingement', 'pain', 'shoulder', 'passive mobilization'], 'conditions': ['Subacromial Impingement']}, 'descriptionModule': {'briefSummary': 'From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.\n\nThe aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome.', 'detailedDescription': 'Subacromial syndrome, also known as subacromial impingement, is the most frequent disorder in the shoulder joint. It has a multifactorial origin and represents a wide spectrum of pathologies. Its main consequences are pain and loss of function in the glenohumeral joint. From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.\n\nThe aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome. To this end, a randomized clinical trial will be carried out in the Montpellier Clinic in Zaragoza. Twenty-two patients will be recruited and randomly assigned to one of the two groups (intervention and control). Both groups will receive a standardized treatment consisting of: 10 sessions of infrared rays, and a program of therapeutic exercises and indications to improve their postural hygiene. In addition, the intervention group will receive a passive joint mobilization in the glenohumeral joint of 5 minutes. Pain intensity, range of motion and functionality of the glenohumeral joint will be measured in the first session before any treatment and in the tenth session after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of subacromial syndrome\n* Pain at rest, which increases when doing active movements\n* Neer´s impingement test positive\n* Hawkins Kennedy test positive\n* Pain lasting more than one month\n* Anteriorization of humeral head\n* Full capacity (physical and cognitive) to participate in the study and give consent.\n\nExclusion Criteria:\n\n* Infiltrations during the previous six months\n* Traumatic origin of pain\n* Complete tear of any rotator cuff tendon\n* Bilateral pain\n* Previous surgical intervention in the affected shoulder\n* Patients planning to start with other treatments during the clinical trial.'}, 'identificationModule': {'nctId': 'NCT03568006', 'briefTitle': 'Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TM_AJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint.\n\nBesides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.', 'interventionNames': ['Other: Specific passive mobilization', 'Other: Standardized treatment (standard protocol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.', 'interventionNames': ['Other: Standardized treatment (standard protocol)']}], 'interventions': [{'name': 'Specific passive mobilization', 'type': 'OTHER', 'description': 'Specific passive mobilizations for the shoulder', 'armGroupLabels': ['Intervention']}, {'name': 'Standardized treatment (standard protocol)', 'type': 'OTHER', 'description': 'Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50830', 'city': 'Villanueva de Gállego', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'San Jorge University', 'geoPoint': {'lat': 41.76917, 'lon': -0.8235}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Montpellier Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Pablo Herrero, PT, PhD. Head of iPhysio Research Group.', 'investigatorFullName': 'Pablo Herrero Gallego', 'investigatorAffiliation': 'Universidad San Jorge'}}}}