Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-23 @ 6:26 AM
Study NCT ID:
NCT01691157
Status:
UNKNOWN
Last Update Posted:
2012-10-12
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in the Physiotherapy Management of Shoulder Impingement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).', 'timeFrame': 'Outcomes measured at 0, 6 and 12 weeks', 'description': 'Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.'}], 'secondaryOutcomes': [{'measure': 'Western Ontario Rotator Cuff Index (WORC', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Secondary outcome measures will focus on function, disability and quality of life, consisting of a combination of generic, region specific and disease-specific health questionnaires. The change in scores from baseline will be measured.'}, {'measure': 'The American Shoulder and Elbow Surgeons function score.', 'timeFrame': '0. 6 and 12 weeks', 'description': 'Limb specific outcome measure'}, {'measure': 'SF-36 Health Survey • SF-36 Health Survey', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Generic measure of health status'}, {'measure': 'Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.', 'timeFrame': '0, 6 and 12 weeks', 'description': 'objective measures of strength and ROM'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subacromial impingement syndrome', 'Rotator cuff', 'Exercise', 'Physiotherapy'], 'conditions': ['Subacromial Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly referred for physiotherapy treatment. This trial aims to compare the effectiveness of an evidence based exercise protocol with usual physiotherapy care.', 'detailedDescription': 'Physiotherapy management of shoulder impingement frequently involves exercise, however there is little evidence underpinning exercise prescription and outcomes are poor. Few trials have investigated which muscles should be targeted and how they should be strengthened with respect to the mode, frequency, duration, intensity and progression. This is a randomized controlled trial(RCT) investigating the effectiveness of an evidence based exercise program for shoulder impingement. This research may have an impact on how physiotherapists provide exercise programs to patients with shoulder impingement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be aged 18 years and older.\n* Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.\n* Positive Hawkins-Kennedy test.\n* Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted external rotation in neutral).\n\nExclusion Criteria:\n\n* Acute traumatic conditions.\n* Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint pathology (e.g. adhesive capsulitis, labral tears).\n* A history of fractures of the upper arm, shoulder or clavicle within the past two years.\n* A history of dislocation of the shoulder within the previous two years.\n* Postoperative conditions involving the upper arm, shoulder or clavicle.\n* Inflammatory or systemic diseases.\n* Current signs and symptoms of acute nerve root pain arising from the cervical or upper thoracic spine.\n* Previous physiotherapy for the same condition involving an exercise regime.\n* Previous corticosteroid injection of the affected shoulder within the past 6 months.\n* Unwilling participant.'}, 'identificationModule': {'nctId': 'NCT01691157', 'acronym': 'EaSI', 'briefTitle': 'Exercise in the Physiotherapy Management of Shoulder Impingement', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': 'The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome', 'orgStudyIdInfo': {'id': '11/NI/0026 version 3.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual physiotherapy without exercise', 'description': 'Will receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.', 'interventionNames': ['Other: Usual physiotherapy without exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Will receive an evidence based exercise protocol but no other physiotherapeutic modalities', 'interventionNames': ['Other: Evidence based exercise protocol']}], 'interventions': [{'name': 'Evidence based exercise protocol', 'type': 'OTHER', 'description': 'An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy', 'armGroupLabels': ['Exercise']}, {'name': 'Usual physiotherapy without exercise', 'type': 'OTHER', 'otherNames': ['Usual care'], 'description': 'Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.', 'armGroupLabels': ['Usual physiotherapy without exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7JB', 'city': 'Belfast', 'state': 'N.Ireland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ingrid Traynor, Physio', 'role': 'CONTACT', 'email': 'ingrid.traynor@belfasttrust.hscni.net', 'phone': '0044289090', 'phoneExt': '2078'}], 'facility': 'Musgrave Park Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Ballymena', 'state': 'N.I', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Brennan, physio', 'role': 'CONTACT', 'email': 'colin.brennan@hscni.net', 'phone': '00442870347853'}], 'facility': 'The Waveney Hospital', 'geoPoint': {'lat': 54.86357, 'lon': -6.27628}}, {'zip': 'BT53 6HB', 'city': 'Ballymoney', 'state': 'N.I', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Brennan, Physio', 'role': 'CONTACT', 'email': 'colin.brennan@northerntrust.hscni.net', 'phone': '00442870347853'}], 'facility': 'Robinson Memorial Hospital', 'geoPoint': {'lat': 55.0708, 'lon': -6.51009}}, {'city': 'Coleraine', 'state': 'N.I', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Brennan, Physio', 'role': 'CONTACT', 'email': 'colin.brennan@hscni.net', 'phone': '00442870347853'}], 'facility': 'The Fort Centre, Physiotherapy Department', 'geoPoint': {'lat': 55.13333, 'lon': -6.66667}}], 'centralContacts': [{'name': 'Catherine E Hanratty, BSc Hons', 'role': 'CONTACT', 'email': 'hanratty-c@email.ulster.ac.uk', 'phone': '0044 2890 368732'}, {'name': 'Joseph G McVeigh, BSc Hons', 'role': 'CONTACT', 'email': 'j.mcveigh@ulster.ac.uk', 'phone': '0044 2890 368148'}], 'overallOfficials': [{'name': 'Joseph G McVeigh, BSc Hons', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, {'name': 'Northern Health and Social Care Trust', 'class': 'OTHER_GOV'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Keele University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Physiotherapy and PhD supervisor', 'investigatorFullName': 'Dr Joseph G McVeigh', 'investigatorAffiliation': 'University of Ulster'}}}}