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

NCT ID: NCT02467803

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30

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.

Conditions

Humeral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

We applied scapula mobilization with shoulder ROM exercises

Group Type: ACTIVE_COMPARATOR

Scapula mobilization

Intervention Type: OTHER

Shoulder ROM exercises

Intervention Type: OTHER

Control

We applied only shoulder ROM exercises

Group Type: OTHER

Shoulder ROM exercises

Intervention Type: OTHER

Interventions

Scapula mobilization

Intervention Type: OTHER

Shoulder ROM exercises

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

HANDE GUNEY

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hande Guney, PhD

Role: CONTACT

hande.guney@hacettepe.edu.tr

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

GO13/55

Identifier Type: -

Identifier Source: org_study_id