Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

Study Overview
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Brief Summary
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The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.

Detailed Description
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Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

Official Title
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Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial

Conditions
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Proximal Humeral Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female patients. Any race Older than 18y Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans. Any type of proximal humeral fracture according to the Neer or AO classification system. Patient should have received non-operative treatment. Exclusion Criteria: Patients younger than 18 y. Patients with multiple other fractures. Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Therapy<br>Subjects who begin therapy immediately after diagnosis of injury. | |
| Late Therapy<br>Subjects who delay therapy for 3 weeks after diagnosis of injury. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Flexion | We measured active forward flexion of the shoulder | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain Likert Scores | Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain. | 3 months, 6 months | 
| External Rotation |  | 3 months, 6 months | 
| Abduction |  | 3 months, 6 months | 
| Disability of the Hand, Shoulder, and Arm Score | Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment. | 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal humerus fracture, rehabilitation, non-operative treatment, DASH and Constant instruments