Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-22 @ 3:34 PM
Study NCT ID:
NCT02304003
Status:
UNKNOWN
Last Update Posted:
2018-08-23
First Post:
2014-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2014-11-26', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for surgery', 'timeFrame': '12 weeks (end of treatment) and 6 months post treatment', 'description': 'Dichotomised questionnaire yes or no'}, {'measure': 'Shoulder function', 'timeFrame': '4 weeks , 12 weeks and 6 months', 'description': "Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'."}, {'measure': 'Shoulder Pain', 'timeFrame': '4 weeks , 12 weeks and 6 months', 'description': 'Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .'}, {'measure': 'Generic health status', 'timeFrame': '12 weeks and 6 months', 'description': 'EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.'}], 'secondaryOutcomes': [{'measure': 'Rotator cuff force', 'timeFrame': '12 weeks ( end of treatment)', 'description': 'Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .'}, {'measure': 'Tendon pain pressure threshold', 'timeFrame': '12 weeks ( end of treatment )', 'description': 'Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.'}, {'measure': 'Analgesics and corticosteroid injections', 'timeFrame': '4 weeks , 12 weeks and 6 months', 'description': 'Analgesics consumption and corticosteroids injections registered on questionaire.'}, {'measure': 'Tendon thickness', 'timeFrame': '12 weeks ( end of treatment )', 'description': 'Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )'}, {'measure': 'Patient global impression of change', 'timeFrame': '4 weeks, 12 weeks & 6 months', 'description': 'To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shoulder tendinopathy', 'Subacromial impingement syndrome', 'Rotator cuff tendinopathy', 'Supraspinatus tendinopathy'], 'conditions': ['Tendinopathy', 'Shoulder Impingement Syndrome', 'Shoulder Pain', 'Subacromial Impingement']}, 'descriptionModule': {'briefSummary': 'Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.', 'detailedDescription': 'There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )\n\n1. Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.\n2. Symptom duration of minimum 3 months.\n3. Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:\n\n * Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop \\& Veer, 2003)\n * Painful arc during active abduction (Ombregt, Bisschop \\& Veer, 2003)\n * Positive Neers sign (Neer, 1972 ; Tennent, Beach \\& Meyers, 2003)\n * Positive Jobes test (Jobe \\& Moynes, 1982 ; Tennent, Beach \\& Meyers, 2003)\n * Positive Hawkins-Kennedy impingement test (Hawkins \\& Kennedy, 1980)\n\nExclusion Criteria:\n\n1. Shoulder pain due to trauma, e.g. fall.\n2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder\n3. History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability\n4. Full thickness rupture of rotator cuff tendon\n5. OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.\n6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine\n7. Subjects suffering from serious psychiatric illness.\n8. Subjects unable to understand English or Norwegian.\n9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.'}, 'identificationModule': {'nctId': 'NCT02304003', 'briefTitle': 'The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Bergen University College'}, 'officialTitle': 'The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'BergenUC'}, 'secondaryIdInfos': [{'id': '2012/2134', 'type': 'OTHER', 'domain': 'Regional Ethics Committee Norway , REK Nord'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Structured Physiotherapy regimen', 'description': 'Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy', 'interventionNames': ['Other: Structured Physiotherapy Regimen']}, {'type': 'OTHER', 'label': 'Standard care', 'description': 'Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Structured Physiotherapy Regimen', 'type': 'OTHER', 'description': 'Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.', 'armGroupLabels': ['Structured Physiotherapy regimen']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Standard follow up in primary care.', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4016', 'city': 'Stavanger', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Sturla Haslerud, Msc', 'role': 'CONTACT', 'email': 'shas@hib.no', 'phone': '93424347', 'phoneExt': '0047'}, {'name': 'Jon Joensen, PhD', 'role': 'CONTACT', 'email': 'jon.joensen@hib.no', 'phone': '55 58 72 31', 'phoneExt': '0047'}], 'facility': 'Department of Physiotherapy, Hillevaag General Practitioner Practice', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'centralContacts': [{'name': 'Jan Magnus Bjordal, Professor', 'role': 'CONTACT', 'email': 'Jan.Bjordal@igs.uib.no', 'phone': '55 58 60 37', 'phoneExt': '0047'}, {'name': 'Sturla Haslerud, Msc', 'role': 'CONTACT', 'email': 'shas@hib.no', 'phone': '93424347', 'phoneExt': '0047'}], 'overallOfficials': [{'name': 'Jan Magnus Bjordal, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bergen University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate', 'investigatorFullName': 'Sturla Haslerud', 'investigatorAffiliation': 'Bergen University College'}}}}