Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05030402
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Maitland Mobilization in Shoulder Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Range of Motion (ROM)', 'timeFrame': 'Baseline and 1, 5, and 7 weeks after treatment', 'description': 'Active ROM of the affected shoulder is measured using a Mechanic Analysis to assess range of motion. These measurements included abduction, flexion, internal rotation, and external rotation.'}, {'measure': 'Change of Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 1, 5, and 7 weeks after treatment', 'description': 'Visual analogue score (VAS) was done at rest and at shoulder movement. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain.'}, {'measure': 'Change of Disabilities of the Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Baseline and 1, 5, and 7 weeks after treatment', 'description': 'Disabilities of the Arm, Shoulder and Hand (DASH) was filled by patient during assessment as 0 equal better functionality and 100 equal worst functionality'}], 'secondaryOutcomes': [{'measure': 'Change of American shoulder and elbow Surgeons" (ASES)', 'timeFrame': 'Baseline and 1, 5, and 7 weeks after treatment', 'description': 'Disabilities of the Arm, Shoulder and Hand (DASH) was filled by patient during assessment as 0 equal worst functionality and 100 is equal better functionality'}, {'measure': 'Change of 36-Item Health Survey (SF-36)', 'timeFrame': 'Baseline and 1, 5, and 7 weeks after treatment', 'description': 'Health Survey (SF-36) was filled by patient during assessment as 0 equal worst health and 100 is equal better health'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Maitland', 'Tendinosis'], 'conditions': ['Tendinosis']}, 'referencesModule': {'references': [{'pmid': '29540872', 'type': 'BACKGROUND', 'citation': 'Haider R, Bashir MS, Adeel M, Ijaz MJ, Ayub A. Comparison of conservative exercise therapy with and without Maitland Thoracic Manipulative therapy in patients with subacromial pain: Clinical trial. J Pak Med Assoc. 2018 Mar;68(3):381-387.'}, {'pmid': '28035910', 'type': 'BACKGROUND', 'citation': 'Hauswirth J, Ernst MJ, Preusser ML, Meichtry A, Kool J, Crawford RJ. Immediate effects of cervical unilateral anterior-posterior mobilisation on shoulder pain and impairment in post-operative arthroscopy patients. J Back Musculoskelet Rehabil. 2017;30(3):615-623. doi: 10.3233/BMR-160566.'}, {'pmid': '23791561', 'type': 'BACKGROUND', 'citation': "Cook C, Learman K, Houghton S, Showalter C, O'Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014 Feb;19(1):18-24. doi: 10.1016/j.math.2013.05.007. Epub 2013 Jun 20."}, {'pmid': '17244697', 'type': 'BACKGROUND', 'citation': 'Carlson M, Hadlock T. Physical therapist management following rotator cuff repair for a patient with postpolio syndrome. Phys Ther. 2007 Feb;87(2):179-92. doi: 10.2522/ptj.20050200. Epub 2007 Jan 23.'}, {'pmid': '26284892', 'type': 'BACKGROUND', 'citation': 'Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'The shoulder is a mobile structure which generates a lot of pathologies. One of them is rotator cuff tendinosis. On the other hand, it has been investigated that Maitland is effective for reducing pain and for mobility in the cervical and lumbar spine and in joints such as the knee and ankle, however, there are few studies that confirm that it is effective in shoulder pathologies.So here the investigatprs want to study the effectiveness of Maitland as an adjunctive treatment for shoulder pathologies, comparing it with conventional physiotherapy treatment, in relation to the reduction of pain and increased mobility. For that the investigators have a randomized clinical trial with two group.', 'detailedDescription': 'Group 1 receives tens, SW, conventional physiotherapy and exercises as treatment. Group 2 receives tens, SW, Mailtland, and exercises. An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a shoulder pathology.\n* Have a restriction at least of two ranges of movement of the shoulder.\n* Sign the consent before starting the study.\n\nExclusion Criteria:\n\n* Patients with a history of shoulder or neck surgery.\n* Patients with neurological damage such as stroke or disease of Parkinson's, as well as those with rheumatism, osteoporosis, surgical fixation, or malignant tumors.\n* Have a radiating pain in shoulder from a cervical injury.\n* Pregnant patients.\n* Patients who do not sign the consent before starting the study."}, 'identificationModule': {'nctId': 'NCT05030402', 'briefTitle': 'Efficacy of Maitland Mobilization in Shoulder Pathology', 'organization': {'class': 'OTHER', 'fullName': 'University of Las Palmas de Gran Canaria'}, 'officialTitle': 'Effec of Maitland in Shoulder Pathology', 'orgStudyIdInfo': {'id': 'ULPGC02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maitland group', 'description': '31 patients receives tens, SW, Maitland, and exercises. An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.', 'interventionNames': ['Procedure: Maitland', 'Procedure: Tens, exercise, SW']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '32 receives tens, SW, conventional physiotherapy and exercises as treatment. An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.', 'interventionNames': ['Procedure: Tens, exercise, SW', 'Procedure: Conventional physiotherapy']}], 'interventions': [{'name': 'Maitland', 'type': 'PROCEDURE', 'description': 'An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.', 'armGroupLabels': ['Maitland group']}, {'name': 'Tens, exercise, SW', 'type': 'PROCEDURE', 'description': 'An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.', 'armGroupLabels': ['Control group', 'Maitland group']}, {'name': 'Conventional physiotherapy', 'type': 'PROCEDURE', 'description': 'An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35006', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'GRUPO ICOT Policlínico Las Palmas.', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}], 'overallOfficials': [{'name': 'Karishma LALWANI MANGTAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Las Palmas de Gran Canaria (ULPGC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Las Palmas de Gran Canaria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karishma Chuhermal Lalwani Mangtani', 'investigatorAffiliation': 'University of Las Palmas de Gran Canaria'}}}}