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

July 5, 2017 updated by: LEE YOON-JE, Hanyang University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CCO Rib Splint
Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.
Device: Application of Rib Splint
Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.
EXPERIMENTAL: Handmade Rib Splint
Subjects were applied Handmade Rib Splint for Rib Fractures treatment.
Device: Application of Rib Splint
Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.

What is the study measuring?

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
Time Frame: We check a pain scale at 30 minutes after splint application
Comparison CCO Rib splint with Handmade Rib splint about pain reduction
We check a pain scale at 30 minutes after splint application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 10, 2017

Primary Completion (ANTICIPATED)

October 31, 2017

Study Completion (ANTICIPATED)

December 31, 2017

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (ACTUAL)

July 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIBSPLINTPRESTUDY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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