Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-02 @ 5:41 AM
Study NCT ID:
NCT07025668
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Different Exercise Approaches in Biceps Brachii Long Head Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants in all three groups performed the given exercises without knowing which group they were included in. Outcome assessments will be performed by an investigator who was blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'three groups with a conventional therapy control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon Cross-Sectional Area', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Ultrasound will be used to measure tendon cross-sectional area.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The patient will be asked to mark the severity of his/her pain at rest, at night, and during general activity on a 10 cm line without numbers, and the point they mark will be measured in millimeters with a ruler. The left end of the line indicates no pain, corresponding to 0 cm, while the pain level increases towards the right end of the line, which is marked at 10 cm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biceps brachii', 'tendinopathy', 'tendon cross-sectional area', 'shoulder pain'], 'conditions': ['Sports Physical Therapy', 'Tendinopathy']}, 'referencesModule': {'references': [{'pmid': '18703976', 'type': 'BACKGROUND', 'citation': 'Friedman DJ, Dunn JC, Higgins LD, Warner JJ. Proximal biceps tendon: injuries and management. Sports Med Arthrosc Rev. 2008 Sep;16(3):162-9. doi: 10.1097/JSA.0b013e318184f549.'}, {'pmid': '17785735', 'type': 'BACKGROUND', 'citation': 'Ahrens PM, Boileau P. The long head of biceps and associated tendinopathy. J Bone Joint Surg Br. 2007 Aug;89(8):1001-9. doi: 10.1302/0301-620X.89B8.19278.'}, {'pmid': '30059449', 'type': 'BACKGROUND', 'citation': 'Chen RE, Voloshin I. Long Head of Biceps Injury: Treatment Options and Decision Making. Sports Med Arthrosc Rev. 2018 Sep;26(3):139-144. doi: 10.1097/JSA.0000000000000206.'}, {'pmid': '20226316', 'type': 'BACKGROUND', 'citation': 'Ryu JH, Pedowitz RA. Rehabilitation of biceps tendon disorders in athletes. Clin Sports Med. 2010 Apr;29(2):229-46, vii-viii. doi: 10.1016/j.csm.2009.12.003.'}]}, 'descriptionModule': {'briefSummary': 'This study was planned to analyze the changes in tendon cross-sectional area and shoulder pain with different exercise approaches applied in biceps brachii long head tendinopathy.', 'detailedDescription': 'There are different conservative treatment options for biceps brachii long head tendinopathy. However, the exercise approaches that can be applied for biceps brachii tendinopathy are not clear in the literature. This study aims to investigate the effectiveness of exercises that include 12 weeks of eccentric training or combined exercise approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having shoulder pain lasting 3 months or more\n* Without a history of surgery, having a diagnosis of shoulder rotator cuff tendinopathy, rotator cuff stage 1-2 tear or subacromial impingement, and having been diagnosed with secondary biceps long head tendinopathy by a physician\n* Pain level during activity \\> 3 according to the visual analog scale\n* Patients who have been informed about the study and have given written consent to participate in the study will be included in the study.\n\nExclusion Criteria:\n\n* Acute shoulder injury\n* History of shoulder and cervical surgery\n* Limitation of passive range of motion\n* History of local corticosteroid injection within the last 12 months\n* Patients who cannot comply with the exercise program will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07025668', 'briefTitle': 'The Effectiveness of Different Exercise Approaches in Biceps Brachii Long Head Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Different Exercise Approaches on Tendon Cross-sectional Area and Pain in Biceps Brachii Long Head Tendinopathy', 'orgStudyIdInfo': {'id': 'BisepsLongHead'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eccentric Exercise Group', 'description': 'In the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given.', 'interventionNames': ['Other: Eccentric Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined-Exercise Group', 'description': 'In the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle.', 'interventionNames': ['Other: Combined Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'In the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group.', 'interventionNames': ['Other: Control Group Exercise']}], 'interventions': [{'name': 'Eccentric Exercise', 'type': 'OTHER', 'description': 'In the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.', 'armGroupLabels': ['Eccentric Exercise Group']}, {'name': 'Combined Exercise', 'type': 'OTHER', 'description': 'In the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.', 'armGroupLabels': ['Combined-Exercise Group']}, {'name': 'Control Group Exercise', 'type': 'OTHER', 'description': 'In the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ebru G SEZİK, Msc', 'role': 'CONTACT', 'email': 'ebrugulozdemiir@gmail.com', 'phone': '05532025875'}], 'facility': 'Hacettepe University Faculty of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ebru G SEZİK, Msc', 'role': 'CONTACT', 'email': 'ebrugulozdemiir@gmail.com', 'phone': '05532025875'}], 'overallOfficials': [{'name': 'Ebru G SEZİK, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ebru Gül SEZİK', 'investigatorAffiliation': 'Hacettepe University'}}}}