Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol

Hacettepe University

Status and phase: Unknown; Early Phase 1

Conditions: Humeral Fracture

Treatments: Other: Shoulder ROM exercises; Other: Scapula mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT02467803

GO13/55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention

Active Comparator group

Description:

We applied scapula mobilization with shoulder ROM exercises

Treatment:

Other: Scapula mobilization

Other: Shoulder ROM exercises

Control

Other group

Description:

We applied only shoulder ROM exercises

Treatment:

Other: Shoulder ROM exercises