Comparison Manufactured Rib Splint With Hand-made Rib Splint

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2017-12-31

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

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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

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CCO Rib Splint

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

Group Type ACTIVE_COMPARATOR

Application of Rib Splint

Intervention Type DEVICE

Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.

Handmade Rib Splint

Subjects were applied Handmade Rib Splint for Rib Fractures treatment.

Group Type EXPERIMENTAL

Application of Rib Splint

Intervention Type DEVICE

Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.

Interventions

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Application of Rib Splint

Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes