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

H

Hanyang University

Status

Unknown

Conditions

Pain, Acute

Treatments

Device: Application of Rib Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT03210792
RIBSPLINTPRESTUDY

Details and patient eligibility

About

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

Full 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

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

CCO Rib Splint
Active Comparator group
Description:
Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.
Treatment:
Device: Application of Rib Splint
Handmade Rib Splint
Experimental group
Description:
Subjects were applied Handmade Rib Splint for Rib Fractures treatment.
Treatment:
Device: Application of Rib Splint

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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