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Clinical Trials/NCT00438633
NCT00438633
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country63 target enrollmentFebruary 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humeral Fractures
Sponsor
Massachusetts General Hospital
Enrollment
63
Locations
1
Primary Endpoint
Shoulder Flexion
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
March 2014
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neal Chung-Jen Chen

Principal Investigator; Hand Service

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Male and Female patients.
  • 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.

Outcomes

Primary Outcomes

Shoulder Flexion

Time Frame: 6 months

We measured active forward flexion of the shoulder

Secondary Outcomes

  • External Rotation(3 months, 6 months)
  • Abduction(3 months, 6 months)
  • Disability of the Hand, Shoulder, and Arm Score(3 months, 6 months)
  • Shoulder Pain Likert Scores(3 months, 6 months)

Study Sites (1)

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