This trial is active, not recruiting.

Condition proximal humeral fractures
Sponsor Massachusetts General Hospital
Start date February 2005
End date December 2017
Trial size 60 participants
Trial identifier NCT00438633, 2004-P-002235


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Subjects who begin therapy immediately after diagnosis of injury.
Subjects who delay therapy for 3 weeks after diagnosis of injury.

Primary Outcomes

shoulder flexion
time frame: 6 months

Secondary Outcomes

shoulder pain Likert scores
time frame: 6 months
external and internal rotation
time frame: 6 months
time frame: 6 months
DASH and Constant scores
time frame: 6 months

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

Official title Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
Principal investigator Neal Chen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.