Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03210792
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Manufactured Rib Splint With Hand-made Rib Splint
Sponsor:
Hanyang University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMRSHRS
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
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
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
RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: