Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-04-04 @ 8:19 PM
Study NCT ID:
NCT01984203
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rotator Cuff Tendinopathy Exercise Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in tendon quality measured on ultra-sonography at 12 weeks', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Baseline demographic and Socioeconomic variables measured at 52 weeks', 'timeFrame': 'Baseline and 52 weeks', 'description': 'Age, sex, duration of symptoms, symptom history, number of patients receiving corticosteroid injections, visits at the patients general practitioner related to their shoulder problem, visits at the secondary healthcare system related to their shoulder problem, sick leave'}], 'primaryOutcomes': [{'measure': 'Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks', 'timeFrame': 'Baseline and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Isometric Strength (MVC)', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change from baseline in Range of movement', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Number of patients referred to or completed arthroscopic shoulder operation', 'timeFrame': '12 months'}, {'measure': 'Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Hospital Anxiety and Depressions score - (HAD)', 'timeFrame': 'Baseline'}, {'measure': 'Scapula Retraction test', 'timeFrame': 'Baseline'}, {'measure': 'Scapula Assisted Test', 'timeFrame': 'Baseline'}, {'measure': 'Change in Euro Qol 5D index (EQ 5D) at 12 weeks', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change in Euro Qol 5D index (EQ 5D) at 52 weeks', 'timeFrame': 'Baseline and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Impingement', 'Rotator Cuff Syndrome', 'Subacromial Impingement Syndrome', 'Exercise', 'Physiotherapy'], 'conditions': ['Rotator Cuff Tendinitis']}, 'referencesModule': {'references': [{'pmid': '28875153', 'type': 'DERIVED', 'citation': 'Ingwersen KG, Jensen SL, Sorensen L, Jorgensen HR, Christensen R, Sogaard K, Juul-Kristensen B. Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial. Orthop J Sports Med. 2017 Aug 28;5(8):2325967117723292. doi: 10.1177/2325967117723292. eCollection 2017 Aug.'}, {'pmid': '27221128', 'type': 'DERIVED', 'citation': 'Ingwersen KG, Hjarbaek J, Eshoej H, Larsen CM, Vobbe J, Juul-Kristensen B. Ultrasound assessment for grading structural tendon changes in supraspinatus tendinopathy: an inter-rater reliability study. BMJ Open. 2016 May 24;6(5):e011746. doi: 10.1136/bmjopen-2016-011746.'}, {'pmid': '25622594', 'type': 'DERIVED', 'citation': 'Ingwersen KG, Christensen R, Sorensen L, Jorgensen HR, Jensen SL, Rasmussen S, Sogaard K, Juul-Kristensen B. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:27. doi: 10.1186/s13063-014-0544-6.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25622594', 'label': 'Protocol article'}]}, 'descriptionModule': {'briefSummary': 'This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for patients diagnosed with Rotator Cuff Tendinopathy is superior to "Standard Low-Load Exercises" (LLE).', 'detailedDescription': 'The trial will be performed as a multicenter randomised controlled trail, including 110 patients diagnosed with Rotator Cuff Tendinopathy from four orthopaedic shoulder clinics in secondary sector in Denmark.\n\nThe PHLE intervention will consist of progressive strengthening exercises performed with heavy load dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with six control visits at a physiotherapy department at the hospitals.\n\nThe LLE exercise program consists of the same exercises as the PHLE, but performed with low load dumbbells.\n\n"Disability of the Arm, Shoulder and Hand (DASH) questionnaire" is used as the primary outcome and is measured 12 weeks post baseline.\n\n12 months post baseline a secondary follow-up will be performed primarily measuring the number of patients referred to an operation.\n\nPatients will be randomised to either PHLE or LLE regime by blocks according to whether they have been referred to corticosteroid injection by their orthopaedic shoulder specialist.\n\n\\*April 2015: (We originally expected to be able to include 260 patients in order to analyze our data according to the sub-groups of exercise group +/- Corticosteroid injection, but inclusion rate has been much lower then expected, and due to time restraints we only expect to include 110 patients)\n\nPrimary investigator and patients will be blinded towards group assignment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 65 years of age\n* history of shoulder complaints lasting at least 3 months prior to enrolment\n* Pain located in the proximal lateral aspect of the upper arm (C5 dermatome) aggravated by abduction\n* Positive "Full Can test" AND/OR "Jobes test/Empty Can test" AND/OR "Resisted External Rotation test"\n* Positive "Hawkins-Kennedy test AND/OR Neers test\n* Ultra-sonographic verification of tendon swelling, hypo echoic areas, fibrillar disruption or neovascularization in the RC.\n\nExclusion Criteria:\n\n* Resting pain more than 40 mm on a visual analogue scale (VAS);\n* Bilateral shoulder pain\n* Less than 90 degrees of active elevation of the arm;\n* Full thickness RC rupture verified by ultra-sonography;\n* Corticosteroid injection within the last 6 weeks;\n* Radiologic verified fracture, calcification larger then 5 mm (vertical distance) in the RC tendon, glenohumeral arthrosis or malalignment in the shoulder complex;\n* Prior surgery or dislocation of the affected shoulder;\n* Clinically suspected labrum lesion, arthritis in the AC-joint, frozen shoulder or symptoms derived from the cervical spine;\n* Sensory or motor deficit in neck or arm;\n* Suspected competing diagnoses (e.g., Rheumatoid arthritis, Cancer, Neurological disorders, Fibromyalgia, Schizophrenia, Suicidal threatened, Borderline personality disorder, or Obsessive Compulsive Disorder);\n* Pregnancy;\n* Inability to fluently understand written and spoken Danish.'}, 'identificationModule': {'nctId': 'NCT01984203', 'acronym': 'RoCTEx', 'briefTitle': 'Rotator Cuff Tendinopathy Exercise Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RoCTExPRIMARY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive Heavy Strength Exercises', 'description': 'The Progressive Heavy Load Exercise group gradually increases the external load from 60%RM to 90%RM and correspondently decreases the number of performed repetitions pr. set for the two rotator cuff exercises. Furthermore 4 sets is performed.\n\nA progressive 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: Progressive Heavy Strength Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Load Exercises', 'description': 'Active exercises comparator continuously training with 60%RM through 12 weeks.\n\nAn 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']}, {'name': 'Progressive Heavy Strength Exercises', 'type': 'OTHER', 'otherNames': ['Scapular stabilization', 'Rotator Cuff', 'Exercise', 'Physiotherapy', 'Posture', 'Progressive exercise', 'Strength training'], 'description': 'All 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 rotator cuff exercises are performed with 4 sets of gradually progressive loading and decreasing the repetitions performed in each set.\n\nWeek 1: 15reps (70% 1RM) Week 2-3: 12 reps (75% 1RM) Week 4-5: 10 reps (80% 1RM) Week 6-8: 8 reps (85% 1RM) Week 9-12: 6 reps (90% 1RM)\n\nThe glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).', 'armGroupLabels': ['Progressive Heavy Strength Exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'Odense University Hospital - Svendborg Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '9800', 'city': 'Aalborg', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'Aalborg University Hospital - Himmerland Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '7100', 'city': 'Vejle', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'Hospital Lillebaelt - Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Birgit Juul-Kristensen, Ass. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, PhD.stud.', 'investigatorFullName': 'Kim Gordon Ingwersen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}