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NCT03210792 Clinical Trial

Comparison Manufactured Rib Splint With Hand-made Rib Splint

Pain, Acute Clinical Trial

— CMRSHRS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03210792
Other study ID # RIBSPLINTPRESTUDY
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 4, 2017
Last updated July 5, 2017
Start date July 10, 2017
Est. completion date December 31, 2017

Study information
Verified date July 2017
Source Hanyang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date December 31, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Application of Rib Splint
Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hanyang University

Outcome
Type Measure Description Time frame Safety issue
Primary The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration Comparison CCO Rib splint with Handmade Rib splint about pain reduction We check a pain scale at 30 minutes after splint application
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