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

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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