Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT03425357
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonoelastography of the Supraspinatus Tendon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-21', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Euro Qol 5D index (EQ-5D-3L). The system consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system contains 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 levels; no problems, some problems and extreme problems. The EQ-VAS range from 0 (worst imaginable health state) to 100 (best imaginable health state).'}, {'measure': 'Disability', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Disability of the Arm, Shoulder and Hand questionnaire (DASH). Each item is rated with a score from 1 (least disability) to 5 (most disability). All scores are added together, producing a raw score, which is then transformed into a score of 100 maximum. A higher score indicates greater disability.'}, {'measure': 'Demographic', 'timeFrame': 'Baseline', 'description': 'Gender, age, bmi, education (level), duration of symptoms, symptom history'}], 'primaryOutcomes': [{'measure': 'Tendon quality (SEL)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in tendon quality (sonoelastography - strain elasticity)'}], 'secondaryOutcomes': [{'measure': 'Tendon quality (MRI)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in tendon quality (MRI)'}, {'measure': 'Tendon quality (US)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in tendon quality (conventional ultrasound)'}, {'measure': 'Strength', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in Isometric Strength (MVC)'}, {'measure': 'Recovery', 'timeFrame': '12 weeks', 'description': 'Change from baseline in Global Perceived Effect (GPE). Ranging from -3 to +3; - being a worsening, 0 being no change and + being an improvement.'}, {'measure': 'Pain', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in Visual Analogue Scale (VAS). Ranging from 0 to 10; 0 being no pain and 10 being severe pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elasticity Imaging Techniques', 'Tendinopathy', 'Rotator Cuff Tendinitis', 'Musculoskeletal Disease']}, 'referencesModule': {'references': [{'pmid': '33403207', 'type': 'DERIVED', 'citation': 'Brage K, Juul-Kristensen B, Hjarbaek J, Boyle E, Kjaer P, Ingwersen KG. Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study. Orthop J Sports Med. 2020 Dec 16;8(12):2325967120965185. doi: 10.1177/2325967120965185. eCollection 2020 Dec.'}]}, 'descriptionModule': {'briefSummary': 'This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.', 'detailedDescription': 'The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark.\n\nThe intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals.\n\nTissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and understand Danish\n* Shoulder pain \\> 3 months\n* Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking)\n* Tendinopathy (MRI)\n\nExclusion Criteria:\n\n* BMI \\> 30\n* Bilateral shoulder pain\n* Supraspinatus full thickness rupture (US)\n* Biceps rupture (US)\n* Calcification in supraspinatus (X-ray)\n* Pregnancy\n* Glenohumeral arthrosis (X-ray)\n* Frozen shoulder\n* Shoulder symptoms originating from neck\n* Shoulder fracture, operation or luxation\n* Known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondylarthropathy or psychiatric disorders\n* Labrum lesion (MRI)\n* Tear (˃1/3 of supraspinatus, vertical height) (MRI)'}, 'identificationModule': {'nctId': 'NCT03425357', 'briefTitle': 'Sonoelastography of the Supraspinatus Tendon', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Responsiveness of Sonoelastography in the Supraspinatus Tendon', 'orgStudyIdInfo': {'id': 'Sonoelastography_Supraspinatus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Load Exercises', 'description': 'An exercise program consisting of 6 active exercises. Two exercises for the rotator cuff: Full Can and Sidelying external rotation Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction.', 'interventionNames': ['Other: Low Load Exercises']}], 'interventions': [{'name': 'Low Load Exercises', 'type': 'OTHER', 'otherNames': ['Scapular stabilization', 'Rotator Cuff', 'Exercise', 'Physiotherapy', 'Posture', 'Progressive exercise', 'Strength training'], 'description': 'All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).\n\nThe glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).', 'armGroupLabels': ['Low Load Exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Birgit Juul-Kristensen, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Sport Science and Biomechanics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karen Brage', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}, {'name': 'Gigtforeningen', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Radiograf Rådet', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D-student', 'investigatorFullName': 'Karen Brage', 'investigatorAffiliation': 'University of Southern Denmark'}}}}