Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT03462420
Status:
UNKNOWN
Last Update Posted:
2019-10-24
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-06', 'releaseDate': '2022-05-31'}], 'estimatedResultsFirstSubmitDate': '2022-05-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of shoulder performance from baseline to 6 weeks after physiotherapy', 'timeFrame': 'At baseline and again after 6 weeks', 'description': 'This test is based on repeated shoulder movements at waist and eye level, and over head work. The test will be performed using Functional Impairment Test- Hand and Neck/ Shoulder/Arm (FIT-HaNSA) tests.'}], 'secondaryOutcomes': [{'measure': 'Shoulder range of motion', 'timeFrame': 'at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment', 'description': 'Shoulder range of motion in flexion, abduction, and external rotation'}, {'measure': 'Shoulder pain and function', 'timeFrame': 'at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment', 'description': 'Shoulder pain and function will be assessed using Shoulder Pain and Disability Index (SPADI) questionnaire'}, {'measure': 'Muscle strength', 'timeFrame': 'at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment', 'description': 'The muscle power of the shoulder flexors and abductors muscles will be assessed'}, {'measure': 'Physical activity level', 'timeFrame': 'at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment', 'description': 'The level of activity will be assessed using Rapid Assessment of Physical Activity (RAPA) questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adhesive capsulitis', 'Frozen shoulder', 'Diabetes', 'Physiotherapy'], 'conditions': ['Adhesive Capsulitis', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27331029', 'type': 'BACKGROUND', 'citation': 'Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016 May 19;6(1):26-34. doi: 10.11138/mltj/2016.6.1.026. eCollection 2016 Jan-Mar.'}, {'pmid': '27182002', 'type': 'BACKGROUND', 'citation': 'Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.'}, {'pmid': '17631739', 'type': 'BACKGROUND', 'citation': 'Laslett LL, Burnet SP, Jones JA, Redmond CL, McNeil JD. Musculoskeletal morbidity: the growing burden of shoulder pain and disability and poor quality of life in diabetic outpatients. Clin Exp Rheumatol. 2007 May-Jun;25(3):422-9.'}, {'pmid': '19506108', 'type': 'BACKGROUND', 'citation': 'Marwick TH, Hordern MD, Miller T, Chyun DA, Bertoni AG, Blumenthal RS, Philippides G, Rocchini A; Council on Clinical Cardiology, American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; Council on Nutrition, Physical Activity, and Metabolism; Interdisciplinary Council on Quality of Care and Outcomes Research. Exercise training for type 2 diabetes mellitus: impact on cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2009 Jun 30;119(25):3244-62. doi: 10.1161/CIRCULATIONAHA.109.192521. Epub 2009 Jun 8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This pilot randomized trial will compare the preliminary effect of a regular physiotherapy (PT) program to a regular PT combined with a progressive walking program (PT+) in patients with and without diabetes who have adhesive capsulitis. After signing the consent form, recruited participants will be randomized into either PT group (control) or PT+ group (experimental). Participants in both groups will be referred to a physical therapy facility. The intervention will be chosen by treating physical therapist. In PT+ group, participants will also be asked to perform free walking at their own pace. Outcomes measures for the primary outcome (shoulder functional performance) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrolment. We expect adding a progressive walking program to regular PT will result in better outcomes.', 'detailedDescription': "In this pilot randomized clinical trial, participants will be recruited from an Orthopedic clinic at St. Joseph's Health Care Centre via surgeon referrals and from local primary health care clinics via posters advertising the study. Potential participants will be contacted by the research team at Hand and Upper Limb Centre (HULC) to arrange for their initial evaluation and sign a consent form. Participants who agree to participate in this study will be asked to complete 2 outcomes questionnaires (i.e. SPADI, RAPA) and Katz comorbidity scale.\n\nNext, patients will be randomly assigned to one of the two groups: regular Physical Therapy program (PT) or regular PT which add a progressive walking program (PT+). Stratified randomization by diabetic status and sex will be used. All participants will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. In PT+ group, participants will be asked to perform free walking at their own pace for 30-45 min, 5 days per week for 6 consecutive weeks and to record their walking date/time on a diary form provided by the research team before commencing the study. Participants in PT+ group will also be provided with accelerometer to accurately estimate their physical activity level. Outcomes measures for the shoulder functional performance test (primary outcome) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with and without diabetes who have adhesive capsulitis\n\nExclusion Criteria:\n\n* Previous shoulder surgery or dislocation\n* Shoulder severe osteoarthritis'}, 'identificationModule': {'nctId': 'NCT03462420', 'briefTitle': 'Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes: A Pilot Randomized Trial', 'orgStudyIdInfo': {'id': 'HSREB#111221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PT+ walking', 'description': 'Participants in this group will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. In addition, participants will be asked to perform free walking at their own pace for 30-45 min, 5 days per week for 6 consecutive weeks and to record their walking date/time on a diary form provided by the research team before commencing the study. Participants in PT+ group will also be provided with accelerometer to accurately estimate their physical activity level.', 'interventionNames': ['Other: Physical Therapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular PT', 'description': 'Participants in this group will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. Participants in this group will not be notified about the walking program.', 'interventionNames': ['Other: Physical Therapy program']}], 'interventions': [{'name': 'Physical Therapy program', 'type': 'OTHER', 'otherNames': ['Exercises'], 'description': 'The physical therapy program will be chosen by the treating therapist. However, the most common physiotherapy interventions include therapeutic exercises, joint mobilization techniques and electrotherapy.', 'armGroupLabels': ['PT+ walking', 'Regular PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Joy C MacDermid, PhD', 'role': 'CONTACT', 'email': 'jmacderm@uwo.ca'}, {'name': 'Sanaa A Alsubheen, PHDc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth Faber, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tom Overend, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Joseph's Health Care London", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Sanaa A Alsubheen, PhD (c)', 'role': 'CONTACT', 'email': 'slasubhe@uwo.ca', 'phone': '0015198789647'}], 'overallOfficials': [{'name': 'Joy C MacDermid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}, {'name': 'Kenneth Faber, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Joseph's Health Care London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-05-31', 'type': 'RELEASE'}, {'date': '2023-03-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Western University, Canada'}}}}