Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-02 @ 10:11 AM
Study NCT ID:
NCT02969135
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Active Exercise After Surgical Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ultrasound imaging of rotator cuff tendons', 'timeFrame': '6 weeks', 'description': 'Assessment of possible re-ruptures of tendons'}, {'measure': 'Ultrasound Imaging of rotator cuff tendons', 'timeFrame': '52 weeks', 'description': 'Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons'}, {'measure': 'Return to work', 'timeFrame': '6 and 52 weeks', 'description': 'Patient-reported time (days) til return to full work capacity.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in Western Ontario Rotator Cuff Index (WORC)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Western Ontario Rotator Cuff Index (WORC)', 'timeFrame': '6 and 52 weeks'}, {'measure': 'Change from baseline in Disability Arm Shoulder Hand (DASH)', 'timeFrame': '6, 12 and 52 weeks'}, {'measure': 'Global Rating Scale (GRS)', 'timeFrame': '6, 12 and 52 weeks', 'description': 'Global perceived treatment effect'}, {'measure': 'Change from baseline in Numeric Pain Rating Scale (NPRS)', 'timeFrame': '6, 12 and 52 weeks'}, {'measure': 'Change from baseline in Shoulder Range of Motion (ROM)', 'timeFrame': '6, 12 and 52 weeks'}, {'measure': 'Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption', 'timeFrame': '12 and 52 weeks', 'description': 'Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '38860727', 'type': 'DERIVED', 'citation': 'Kjaer BH, Svensson RB, Warming S, Peter Magnusson S. Supraspinatus Muscle and Tendon Characteristics 1 Year After Surgical Rotator Cuff Repair Compared With Contralateral Shoulder: Data From the CUT-N-MOVE Trial. Am J Sports Med. 2024 Jul;52(8):2082-2091. doi: 10.1177/03635465241255143. Epub 2024 Jun 11.'}, {'pmid': '33471547', 'type': 'DERIVED', 'citation': 'Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.'}, {'pmid': '30176943', 'type': 'DERIVED', 'citation': 'Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.'}]}, 'descriptionModule': {'briefSummary': 'Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.\n\nA rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.\n\nThe Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.\n\nTherefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.\n\nShortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men above 18 years\n* Operated due to traumatic full thickness RC-tear\n* Involving supraspinatus (full thickness and width)\n* Present with reduced arm elevation strength and pain\n* Clinical diagnosis verified by arthroscopy\n* Fully repairable RC-tear\n\nExclusion Criteria:\n\n* Patients with non-traumatic RC-tears of the shoulder\n* Patients with isolated teres minor or subscapularis tear\n* Patients with partial thickness/ width tear\n* Prior shoulder surgery (all shoulder joints)\n* Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis\n* Inability to speak or read Danish\n* Inability to perform and maintain the physical training\n* Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.'}, 'identificationModule': {'nctId': 'NCT02969135', 'briefTitle': 'Progressive Active Exercise After Surgical Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up', 'orgStudyIdInfo': {'id': 'FYS012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive early passive and active movement', 'description': 'Active exercise starts one week after surgery.', 'interventionNames': ['Behavioral: Progressive early passive and active movement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Limited early passive movement', 'description': 'Active exercise starts six weeks after surgery.', 'interventionNames': ['Behavioral: Limited early passive movement']}], 'interventions': [{'name': 'Progressive early passive and active movement', 'type': 'BEHAVIORAL', 'description': 'Post-surgical physical therapy including active exercise', 'armGroupLabels': ['Progressive early passive and active movement']}, {'name': 'Limited early passive movement', 'type': 'BEHAVIORAL', 'description': 'Post-surgical physical therapy including passive mobilisation', 'armGroupLabels': ['Limited early passive movement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg and Frederiksberg Hospitals', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marius Henriksen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marius Henriksen', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}