NCT03210792

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

July 4, 2017

Last Update Submit

July 5, 2017

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CCO Rib Splint

ACTIVE COMPARATOR

Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment.

Device: Application of Rib Splint

Handmade Rib Splint

EXPERIMENTAL

Subjects were applied Handmade Rib Splint for Rib Fractures treatment.

Device: Application of Rib Splint

Interventions

Application of Rib SplintDEVICE

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

CCO Rib SplintHandmade Rib Splint

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have rib fractures and age was over 18 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 7, 2017

Study Start

July 10, 2017

Primary Completion

October 31, 2017

Study Completion

December 31, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07