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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fracture focused on measuring humeral fracture, exercise, musculoskeletal manipulations

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    May 26, 2015
    Last Updated
    June 5, 2015
    Sponsor
    Hacettepe University
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    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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