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

June 19, 2019 updated by: Neal Chung-Jen Chen, Massachusetts General Hospital

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the MGH Hand and Upper Extremity or Trauma service

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Early Therapy
Subjects who begin therapy immediately after diagnosis of injury.
Late Therapy
Subjects who delay therapy for 3 weeks after diagnosis of injury.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain Likert Scores
Time Frame: 3 months, 6 months
Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.
3 months, 6 months
External Rotation
Time Frame: 3 months, 6 months
3 months, 6 months
Abduction
Time Frame: 3 months, 6 months
3 months, 6 months
Disability of the Hand, Shoulder, and Arm Score
Time Frame: 3 months, 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2005

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-P-002235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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