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

Proximal Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438633
• Other study ID #: 2004-P-002235
• Status: Completed
• Start date: February 2005
• Est. completion date: March 2014

Study information

• Verified date: June 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fractures
• Shoulder Fractures

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Flexion	We measured active forward flexion of the shoulder	6 months
Secondary	Shoulder Pain Likert Scores	Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.	3 months, 6 months
Secondary	External Rotation		3 months, 6 months
Secondary	Abduction		3 months, 6 months
Secondary	Disability of the Hand, Shoulder, and Arm Score	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