Clinical trial NCT00438633: Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
Official title: Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fractures
Keywords: proximal humerus fracture
rehabilitation
non-operative treatment
DASH and Constant instruments
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the MGH Hand and Upper Extremity or Trauma service

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

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.

Eligibility 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.

Primary outcomes:
measure: Shoulder Flexion
timeFrame: 6 months
Secondary outcomes:
measure: Shoulder Pain Likert Scores
timeFrame: 3 months, 6 months
measure: External Rotation
timeFrame: 3 months, 6 months
measure: Abduction
timeFrame: 3 months, 6 months
measure: Disability of the Hand, Shoulder, and Arm Score
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.