Comparison Manufactured Rib Splint With Hand-made Rib Splint

Not Applicable

• Conditions: Pain, Acute
• Interventions: Device: Application of Rib Splint

• Registration Number: NCT03210792
• Lead Sponsor: Hanyang University

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

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Study Start: 2017-07-10
• Primary Completion: 2017-10-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCO Rib Splint	Application of Rib Splint	Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.
Handmade Rib Splint	Application of Rib Splint	Subjects were applied Handmade Rib Splint for Rib Fractures treatment.

Primary Outcome Measures

Name	Time	Method
The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration	We check a pain scale at 30 minutes after splint application	Comparison CCO Rib splint with Handmade Rib splint about pain reduction