Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
1 other identifier
observational
63
1 country
1
Brief Summary
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
June 21, 2019
CompletedJune 21, 2019
June 1, 2019
9.1 years
February 20, 2007
September 14, 2018
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shoulder Flexion
We measured active forward flexion of the shoulder
6 months
Secondary Outcomes (4)
Shoulder Pain Likert Scores
3 months, 6 months
External Rotation
3 months, 6 months
Abduction
3 months, 6 months
Disability of the Hand, Shoulder, and Arm Score
3 months, 6 months
Study Arms (2)
Early Therapy
Subjects who begin therapy immediately after diagnosis of injury.
Late Therapy
Subjects who delay therapy for 3 weeks after diagnosis of injury.
Eligibility Criteria
Patients from the MGH Hand and Upper Extremity or Trauma service
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 35727196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Neal Chen
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Neal Chen, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Hand Service
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 22, 2007
Study Start
February 1, 2005
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 21, 2019
Results First Posted
June 21, 2019
Record last verified: 2019-06