Humeral Fracture Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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