Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Fractures of the proximal humerus and the humeral head are most common injuries and the management is challenging. Functional therapy with short immobilization, followed by an accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient management option. This prospective randomized study is aim to assess the function of the upper extremity of patients who will be assigned to nonoperative treatment of a proximal humeral fracture. The primary objective is the Constant score. Secondary objectives are the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range of motion (ROM), pain and depression level with Beck Depression Scale.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
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
First Submitted
Initial submission to the registry
May 26, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedJune 10, 2015
May 1, 2015
7 months
May 26, 2015
June 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Constant Score
Patients will be followed for 6 months. The differences between baseline score and at the end of 6 months score will be assessed.
Study Arms (2)
Intervention
ACTIVE COMPARATORWe applied scapula mobilization with shoulder ROM exercises
Control
OTHERWe applied only shoulder ROM exercises
Interventions
Eligibility Criteria
You may qualify if:
- Patients will be recruited if they have radiologically proven, closed fracture of the humerus according to American Orthopedics and Neer classification.
You may not qualify if:
- skeletally immature patients
- patients presenting to the hospital 10 days or more after injury
- patients with open fractures or multiple trauma
- pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others
- patients with a history of drug or alcohol abuse
- patients with cooperation problems or problems in attending all scheduled study visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 10, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Last Updated
June 10, 2015
Record last verified: 2015-05