Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00438633 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 22, 2007
Last Update Posted
: February 9, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Proximal Humeral Fractures |
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 |
Group/Cohort |
---|
1
Subjects who begin therapy immediately after diagnosis of injury.
|
2
Subjects who delay therapy for 3 weeks after diagnosis of injury.
|
- shoulder flexion [ Time Frame: 6 months ]
- shoulder pain Likert scores [ Time Frame: 6 months ]
- external and internal rotation [ Time Frame: 6 months ]
- abduction [ Time Frame: 6 months ]
- DASH and Constant scores [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438633
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Neal Chen, MD | Massachusetts General Hospital |
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 Key Record Dates |
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 |