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

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ClinicalTrials.gov Identifier: NCT00438633
Recruitment Status : Active, not recruiting
First Posted : February 22, 2007
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

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

Condition or disease
Proximal Humeral Fractures

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
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
Study Start Date : February 2005
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Subjects who begin therapy immediately after diagnosis of injury.
2
Subjects who delay therapy for 3 weeks after diagnosis of injury.



Primary Outcome Measures :
  1. shoulder flexion [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. shoulder pain Likert scores [ Time Frame: 6 months ]
  2. external and internal rotation [ Time Frame: 6 months ]
  3. abduction [ Time Frame: 6 months ]
  4. DASH and Constant scores [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the MGH Hand and Upper Extremity or Trauma service
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438633


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Neal Chen, MD Massachusetts General Hospital

Responsible Party: Neal Chung-Jen Chen, Principal Investigator; Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438633     History of Changes
Other Study ID Numbers: 2004-P-002235
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Neal Chung-Jen Chen, Massachusetts General Hospital:
proximal humerus fracture
rehabilitation
non-operative treatment
DASH and Constant instruments

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries