Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-07 @ 8:14 PM
Study NCT ID:
NCT00709566
Status:
UNKNOWN
Last Update Posted:
2010-07-23
First Post:
2008-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-22', 'studyFirstSubmitDate': '2008-07-01', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale', 'timeFrame': '0, 9, 18 weeks'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale for Pain', 'timeFrame': '0,9,18 weeks'}, {'measure': 'WOMAC total score, pain and stiffness subscales', 'timeFrame': '0,9,18 weeks'}, {'measure': 'Global Assessment of Change- 7 Point Likert Scale', 'timeFrame': '9,18 weeks'}, {'measure': 'Hip Range of motion using goniometry', 'timeFrame': '0,9,18 weeks'}, {'measure': 'Short Form-36v2 (Quality of Life)', 'timeFrame': '0,9,18 weeks'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '0,9,18 weeks'}, {'measure': 'Physiotherapy Out-Patient Survey for Patient Satisfaction', 'timeFrame': '18 weeks'}, {'measure': 'Medication Usage (pain diary and Medication Quantification Scale)', 'timeFrame': '0,9,18 weeks'}, {'measure': 'International Physical Activity Questionnaire (Short version)', 'timeFrame': '0,9,18 weeks'}, {'measure': 'Repeated sit to stand test', 'timeFrame': '0,9,18 weeks'}, {'measure': '50 foot walk test', 'timeFrame': '0,9,18 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip', 'osteoarthritis', 'exercise', 'manual therapy'], 'conditions': ['Hip Osteoarthritis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'French HP (2007). Physiotherapy management of osteoarthritis of the hip: a survey of current practice in acute hospitals and private practice in the Republic of Ireland, Physiotherapy, 93 (4), 253-260.'}, {'pmid': '19152689', 'type': 'BACKGROUND', 'citation': "French HP, Cusack T, Brennan A, White B, Gilsenan C, Fitzpatrick M, O'Connell P, Kane D, Fitzgerald O, McCarthy GM. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2009 Jan 19;10:9. doi: 10.1186/1471-2474-10-9."}]}, 'descriptionModule': {'briefSummary': 'Hip osteoarthritis is a major cause of disability and reduced quality of life. Physiotherapy, which encompasses a range of interventions such as exercise therapy, manual therapy, education and electrophysical agents, is a core component of management. To date, exercise therapy to date has the greatest evidence of effect . However, this evidence is limited as only a short-term benefit has been identified and improvements in pain and function decline over time. There is some limited evidence for a beneficial effect of manual therapy over exercise. However, clinically these interventions are used in combination, not in isolation. To date, no research has investigated the combined effect of exercise and manual therapy in hip OA.\n\nA multi-centre randomised controlled trial that compares the clinical effectiveness of a combination of manual therapy and exercise to exercise therapy only will be conducted.', 'detailedDescription': "A multi-centre RCT that evaluates the clinical effectiveness of two physiotherapy interventions for patients with osteoarthritis of the hip will be conducted The methodology will follow CONSORT (Consolidation of Standards of Reporting Trials) guidelines. Ethical approval for the study has been obtained from the Research Ethics Committees of the participating hospitals (Beaumont, St Vincent's University, Mater Misercordiae University Hospitals, Adelaide Meath Hospital Dublin, incorporating National Children's Hospital). Patients will be assessed at baseline, 9 weeks, (end of treatment) and 18 weeks. The treating therapists will be blinded to outcome assessments. Subjects cannot be blinded due to the nature of the interventions.\n\nAll patients with a diagnosis of Hip OA referred for physiotherapy from rheumatologists, GPs and orthopaedic consultants will be considered for inclusion into the RCT. Four similarly matched physiotherapy departments will be used: Beaumont Hospital (BH), St Vincent's University Hospital (SVUH) Adelaide Meath Hospital Dublin, incorporating National Children's Hospital) and Mater Misericordiae University Hospital (MMH).\n\nConsenting subjects will be randomly allocated to one of 3 groups\n\n1. Exercise therapy (comprising strengthening, range of motion and aerobic exercise)\n2. Combined Exercise therapy and Manual Therapy\n3. Control group (Waiting List). These patients will remain on the waiting list for a 9 week period and will then be randomized to one of the two intervention groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) (Altman et al, 1991):\n\n * Subjective complaint of hip pain with either hip internal rotation \\< 15 degrees and hip flexion \\<115 degrees or \\>15 degrees hip internal rotation and pain on hip internal rotation\n * morning stiffness less than or equal to 60 minutes, age \\> 50 years.\n* Age 40-80 years except in 2 above (age \\>50 years).\n* Radiological evidence of osteoarthritis (2 of the following 3 criteria):\n\n * osteophytes\n * joint space narrowing\n * ESR\\<20mm/hr (American College of Rheumatology Criteria for the Classification and Reporting of Osteoarthritis of the Hip)\n* Referred for physiotherapy\n\nExclusion Criteria:\n\n* Previous hip arthroplasty, history of congenital/adolescent hip disease\n* Clinical signs of lumbar spine disease\n* Physiotherapy in previous 6 months\n* Pregnancy\n* Hip fracture\n* Contraindications to exercise therapy\n* Contraindications to manual therapy\n* On waiting list for joint replacement within the next 18 weeks\n* Rheumatic diseases e.g. Rheumatoid Arthritis, Ankylosing Spondylitis, etc\n* Hip cortisone injection in previous 30 days'}, 'identificationModule': {'nctId': 'NCT00709566', 'acronym': 'EMPART', 'briefTitle': 'EMPART - Exercise and Manual Physiotherapy Arthritis Research Trial', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'RoyalCSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Waiting List control.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise therapy', 'interventionNames': ['Behavioral: Exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Combined therapy', 'description': 'Combined Exercise therapy and Manual Therapy', 'interventionNames': ['Behavioral: Combined exercise and manual therapy']}], 'interventions': [{'name': 'Exercise therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme.', 'armGroupLabels': ['Exercise therapy']}, {'name': 'Combined exercise and manual therapy', 'type': 'BEHAVIORAL', 'description': 'Patients will attend physiotherapy once a week for 8 weeks, where they will receive a combination of exercise therapy and manual therapy. Exercise will be supplemented by a home based exercise programme', 'armGroupLabels': ['Combined therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Dublin 24', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Adelaide Meath Hospital Dublin incorporating the National Childrens Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'Dublin 4', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': "St Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'Dublin 7', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'Dublin 9', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Geraldine McCarthy, MD, FRCPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Surgeons in Ireland'}, {'name': 'Tara Cusack, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Dublin, Ireland'}, {'name': 'Helen French, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Surgeons in Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Geraldine McCarthy', 'oldOrganization': 'Royal College of Surgeons in Ireland'}}}}