Comparison Manufactured Rib Splint With Hand-made Rib Splint

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study

Conditions
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Pain, Acute

Intervention / Treatment
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* Device: Application of Rib Splint


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCO Rib Splint<br>Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment. | Device: Application of Rib Splint<br>* Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.<br>|
| Experimental: Handmade Rib Splint<br>Subjects were applied Handmade Rib Splint for Rib Fractures treatment. | Device: Application of Rib Splint<br>* Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | We check a pain scale at 30 minutes after splint application |