Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
Primary Purpose
Humeral Fracture
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Scapula mobilization
Shoulder ROM exercises
Sponsored by
About this trial
This is an interventional treatment trial for Humeral Fracture focused on measuring humeral fracture, exercise, musculoskeletal manipulations
Eligibility Criteria
Inclusion Criteria:
- Patients will be recruited if they have radiologically proven, closed fracture of the humerus according to American Orthopedics and Neer classification.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention
Control
Arm Description
We applied scapula mobilization with shoulder ROM exercises
We applied only shoulder ROM exercises
Outcomes
Primary Outcome Measures
Constant Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02467803
Brief Title
Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
5. Study Description
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.
Detailed Description
In this prospective randomized controlled trial, informed consent forms were obtained from all participants and they were informed about the study based on the Declaration of Helsinki. The study was approved by local ethics committee of Hacettepe University (GO13/55). After comprehensive clinical evaluation, subjects were randomly assigned to the intervention group or the control group, using Random Allocation Software. The intervention group received scapular mobilization with upper extremity ROM exercises, the control group received only shoulder ROM exercises.
Patients with a radiographically proven, closed fracture of the proximal humerus admitted to the emergency department of Hacettepe University Hospital, who were considered suitable for primary nonoperative management by the orthopedic surgeon on charge, were asked to participate in this investigation.
The exclusion criteria are (1) skeletally immature patients (2) patients presenting to the hospital 10 days or more after injury (3) patients with open fractures or multiple trauma (4) pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others (5) patients with a history of drug or alcohol abuse (6) patients with cooperation problems or problems in attending all scheduled study visits.
Patients' demographics (ie, gender, age, profession, smoking, concomitant diseases, medication) and injury characteristics (ie, accident type, energy level of trauma, concomitant injuries, fracture classification) will be recorded. Patients will be asked to rate their upper limb function 1 week before the accident to determine their baseline DASH score using the extended 3-modular questionnaire.13 Normalized DASH scores range from 0 (perfect function) to 100 (functionless extremity/joint).
Radiographs will be obtained in anterior-posterior projection and Neer's view upon admission in the emergency department and after manipulation. Additional computed tomography (CT) scans will be ordered at the discretion of the treating surgeon. Fractures were classified according to the American Orthopedics and Neer scheme by the orthopedic surgeon.
The intervention group will receive scapular mobilization after the sling will be removed. Scapular mobilization will be applied 3 times a week, a total of 24 sessions for 8 weeks. Each session lasted around 15-20 minutes. The shoulder flexion and abduction ROM exercises will be showed to the patients and performed 3 times, 10 sets on each day after the sling will be removed.
The control group will only perform the shoulder ROM exercises. Patients will be monitored and physically examined on the day sling removed (approximately 4 week after injury), 3 and 6 months after injury. Primary outcome measures comprised raw Constant scores and differences to the contralateral, healthy shoulder. The Constant score will show the change from baseline in shoulder functional outcomes at 6 months after injury) Pain levels will be measured on a 0-10 cm (0=no pain, 10=severe pain) visual analogue scale (VAS). The Constant score, DASH, pain level, shoulder ROM and Beck Depression Scale will be recorded on the day sling removed and 6 months after injury. Plain radiographs of the injured shoulder in 2 planes were obtained to determine fracture healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fracture
Keywords
humeral fracture, exercise, musculoskeletal manipulations
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
We applied scapula mobilization with shoulder ROM exercises
Arm Title
Control
Arm Type
Other
Arm Description
We applied only shoulder ROM exercises
Intervention Type
Other
Intervention Name(s)
Scapula mobilization
Intervention Type
Other
Intervention Name(s)
Shoulder ROM exercises
Primary Outcome Measure Information:
Title
Constant Score
Time Frame
Patients will be followed for 6 months. The differences between baseline score and at the end of 6 months score will be assessed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be recruited if they have radiologically proven, closed fracture of the humerus according to American Orthopedics and Neer classification.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hande Guney, PhD
Email
hande.guney@hacettepe.edu.tr
12. IPD Sharing Statement
Citations:
PubMed Identifier
35727196
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.
Results Reference
derived
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Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
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