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Comparison Manufactured Rib Splint With Hand-made Rib Splint (CMRSHRS)

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of Rib Splint
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects who have rib fractures and age was over 18 years old

Exclusion Criteria:

  • Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    CCO Rib Splint

    Handmade Rib Splint

    Arm Description

    Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.

    Subjects were applied Handmade Rib Splint for Rib Fractures treatment.

    Outcomes

    Primary Outcome Measures

    The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
    Comparison CCO Rib splint with Handmade Rib splint about pain reduction

    Secondary Outcome Measures

    Full Information

    First Posted
    July 4, 2017
    Last Updated
    July 5, 2017
    Sponsor
    Hanyang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03210792
    Brief Title
    Comparison Manufactured Rib Splint With Hand-made Rib Splint
    Acronym
    CMRSHRS
    Official Title
    Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 10, 2017 (Anticipated)
    Primary Completion Date
    October 31, 2017 (Anticipated)
    Study Completion Date
    December 31, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hanyang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention. The primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration. VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
    Detailed Description
    Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection. RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CCO Rib Splint
    Arm Type
    Active Comparator
    Arm Description
    Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.
    Arm Title
    Handmade Rib Splint
    Arm Type
    Experimental
    Arm Description
    Subjects were applied Handmade Rib Splint for Rib Fractures treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Application of Rib Splint
    Intervention Description
    Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.
    Primary Outcome Measure Information:
    Title
    The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
    Description
    Comparison CCO Rib splint with Handmade Rib splint about pain reduction
    Time Frame
    We check a pain scale at 30 minutes after splint application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects who have rib fractures and age was over 18 years old Exclusion Criteria: Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.

    12. IPD Sharing Statement

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    Comparison Manufactured Rib Splint With Hand-made Rib Splint

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