Comparison Manufactured Rib Splint With Hand-made Rib Splint

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03210792

Acronym

CMRSHRS

Enrollment

Registered

2017-07-07

Start date

2017-07-10

Completion date

2017-12-31

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

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

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

Interventions

DEVICEApplication of Rib Splint

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026