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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210792
Recruitment Status : Unknown
Verified July 2017 by LEE YOON-JE, Hanyang University.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
LEE YOON-JE, 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


Condition or disease Intervention/treatment Phase
Pain, Acute Device: Application of Rib Splint Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study
Estimated Study Start Date : July 10, 2017
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : December 31, 2017

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: LEE YOON-JE, Clinical Assistant Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT03210792    
Other Study ID Numbers: RIBSPLINTPRESTUDY
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms