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Clinical Trials/NCT03210792
NCT03210792
Unknown
Not Applicable

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

Hanyang University0 sites12 target enrollmentJuly 10, 2017
ConditionsPain, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Hanyang University
Enrollment
12
Primary Endpoint
The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
December 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LEE YOON-JE

Clinical Assistant Professor

Hanyang University

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.

Outcomes

Primary Outcomes

The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration

Time Frame: We check a pain scale at 30 minutes after splint application

Comparison CCO Rib splint with Handmade Rib splint about pain reduction

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