Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05054920
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2021-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-03', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-09-19', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder function', 'timeFrame': 'one month', 'description': 'shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.'}], 'secondaryOutcomes': [{'measure': 'tendon thickness, fibrillar pattern and echogenicity', 'timeFrame': 'one month', 'description': 'tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography'}, {'measure': 'subacromial space', 'timeFrame': 'one month', 'description': 'shoulder subacromial space as measured by Ultrasonography'}, {'measure': 'Pain measured by Visual analogue scale (VAS)', 'timeFrame': 'one month', 'description': 'pain as measured by Visual analogue scale which a 10 cm scale marked at the beginning zero indicating no pain and 10 at the end indicating worst pain'}, {'measure': 'ESR', 'timeFrame': 'one month', 'description': 'Erythrocyte sedimentation rate'}, {'measure': 'disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)', 'timeFrame': 'one month', 'description': 'disease activity score 28 Erythrocyte sedimentation rate High disease activity is defined as a DAS 28 ESR\\>5.1, moderate activity as a DAS 28 ESR between 3.2 and ≤5.1, low activity as a DAS 28 ESR between 3.2 and \\>2.6, and remission as a DAS 28 ESR less than 2.6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Rotator Cuff Tendinosis', 'Tendinopathy']}, 'descriptionModule': {'briefSummary': 'Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with Rheumatoid arthritis (RA).\n\nMoreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.\n\nPatients will be randomly assigned into either concentric or eccentric exercise group. Randomizations will be done using computer random generated numbers.', 'detailedDescription': 'Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with RA. Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.\n\nPatients will be randomizations using computer random generated numbers. patients will receive either eccentric or concentric exercises for internal, external rotators and abductors muscles All patient will do stretching for posterior capsule and pectoralis minor Tendon biological changes and subacromial space will be assessed using musculoskeletal ultrasonography Shoulder function will be assessed using SPADI (shoulder pain and disability index Pain will be assessed using Visual Analogue Scale (VAS) Rheumatoid arthritis disease activity will be assessed using Disease Activity Score-28 for Rheumatoid Arthritis with erythrocyte sedimentation rate (DAS 28 ESR) patient will be assessed at base-line and after finishing of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients diagnosed with RA according to 2010 (American College of Rheumatology)(ACR)/European League Against Rheumatism (EULAR) Classification Criteria for RA\n2. Patients diagnosed with rotator cuff tendinopathy based on clinical and musculoskeletal Ultrasonography (MSUS) finding.\n3. Patient complaining of shoulder pain for at least 3 months\n4. Positive jobs test or hornblower sign or left off test\n5. Age ranged from 18 to 50 years.\n\nExclusion Criteria:\n\n1. Patient indicated for surgical repair of rotator cuff\n2. Patient with previous shoulder surgery.\n3. Patient with history of intra-articular shoulder fracture.\n4. Patient with history of shoulder dislocation\n5. Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT05054920', 'briefTitle': 'Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'Mina'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concentric exercises group', 'description': 'patient will do Concentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist. During each session.\n\nExercise will be in the form of glenohumeral scaption, internal and external rotation exercises.\n\npatient will also do stretching for posterior capsule and pectoralis minor', 'interventionNames': ['Other: concentric exercises', 'Other: Stretching']}, {'type': 'EXPERIMENTAL', 'label': 'Eccentric exercises group', 'description': 'patient will do eccentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist during each session.\n\nExercise will be in the form of glenohumeral scaption, internal and external rotation exercises.\n\npatient will also do stretching for posterior capsule and pectoralis minor', 'interventionNames': ['Other: eccentric exercises', 'Other: Stretching']}], 'interventions': [{'name': 'concentric exercises', 'type': 'OTHER', 'description': 'concentric exercises for rotator cuff. internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients', 'armGroupLabels': ['Concentric exercises group']}, {'name': 'eccentric exercises', 'type': 'OTHER', 'description': 'Eccentric exercises exercises for rotator cuff internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients', 'armGroupLabels': ['Eccentric exercises group']}, {'name': 'Stretching', 'type': 'OTHER', 'description': 'stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times', 'armGroupLabels': ['Concentric exercises group', 'Eccentric exercises group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Badr University in Cairo (BUC)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed Shawki Abdelsalam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Professor,Faculty of Physical Therapy Cairo University'}, {'name': 'Mona Fagaal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Professor, Faculty of Physical Therapy Badr University in Cairo'}, {'name': 'Mohammed Moustafa Aldosouki Hegazy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer,Faculty of Physical Therapy Cairo University'}, {'name': 'Rasmia Mohamed Hassan ElGohry, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Badr University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mina Magdy Wahba', 'investigatorAffiliation': 'Badr University'}}}}