University of Utah - Orthopedics
Salt Lake City, Utah, 84108, United States
NCT Number: NCT03430167
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.
Looking for future studies?
Notify Me61 year and older
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84108, United States
All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function.
Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively.
Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty.
Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be given a set of instructions for completing home therapy for range of motion and strengthening
Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Compare change in The Western Ontario Osteoarthritis Score (WOOS) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
The WOOS includes 19 items (0-100 visual analog scale) which assess 1. pain and physical symptoms 2. sports, recreation, and work 3. lifestyle function, and 4. emotional function. A higher score represents a worse outcome.
Time frame: Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively
Compare change in American Shoulder and Elbow Surgeons Score (ASES) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
The ASES includes 1 pain item (0-100 visual analog scale) and 10 items which assess functional status (0=Unable to do, 1=Very difficult to do, 2=Somewhat difficult, 3=Not difficult). A higher score represents a better outcome.
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Washington University School of Medicine
Other
Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06611761
Agnosia, Analgesia
Oviedo, Principality of Asturias, Spain
View Trial DetailsNCT03735173
Arthralgia, Arthritis
Rochester, Minnesota, United States
View Trial DetailsNCT03156543
Arthralgia, Joint Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT06162858
Healthy, Shoulder Arthropathy Associated With Other Conditions
Ghent, Belgium
View Trial Details