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Completed

NCT Number: NCT03430167

Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

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.

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Key information

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah - Orthopedics

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
  • A pre-operative plan for RTSA
  • Age >60

Exclusion criteria

  • Active infection
  • Incompetent deltoid muscle
  • Unwillingness or inability to participate in a home exercise program
  • Medically unfit for operative intervention
  • Revision RTSA
  • RTSA for glenohumeral osteoarthritis or proximal humerus fracture
  • Unwillingness to participate in the study
  • Inability to read or comprehend written instructions

Treatment and study plan

Home Therapy

Other

Patients will be given a set of instructions for completing home therapy for range of motion and strengthening

formal therapy

Other

Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises

Primary outcomes

  1. Range of Motion Outcomes

    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.

Secondary outcomes

  1. Clinical Outcome Scores - Quality of Life

    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.

  2. Clinical Outcome Scores - Functional

    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.

  3. Clinical Outcome Scores - Pain

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2018
Registry last updated
Mar 23, 2023

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.

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