Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes
NCT ID: NCT03462420
Last Updated: 2019-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-09-03
2020-05-31
Brief Summary
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Detailed Description
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Next, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PT+ walking
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.
Physical Therapy program
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.
Regular PT
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.
Physical Therapy program
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.
Interventions
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Physical Therapy program
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Shoulder severe osteoarthritis
18 Years
ALL
Yes
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Principal Investigators
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Joy C MacDermid, PhD
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Kenneth Faber, MD
Role: STUDY_CHAIR
St. Joseph's Health Care London
Locations
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St. Joseph's Health Care London
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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HSREB#111221
Identifier Type: -
Identifier Source: org_study_id
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