Infuence of Kinesiotaping on Pulmonary Function Improveme... | NCT05753982

Studies
Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture

NCT05753982

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Feb 6, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Chest Wall Injury

Interventions

Kinesiotape placement

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2022Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Feb 22, 2023

First Posted Date

Mar 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2024

Last Update Posted Date

Feb 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marko Zlicar, Principal Investigator, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Elastic tapes, named "kinesiotapes" have a limited, but proven influence on pain reduction, improvement in muscular strength and joint function. It can be hypothetised that by using kinesiotape techniques on damaged chest wall (due to mostly rib fracture) we can improve not only analgesia, but also improve lung function tests and speed recovery.

Detailed Description

Chest wall injury changes the function of chest wall muscles and other structures, which in turn influences respiratory function and cause significant pain.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
kinesiotape	Experimental	Placement of kinesiotapes, using ligament techniques on the injured side of chest, focusing on the point of maximal pain.	Other: Kinesiotape placement
control	Placebo Comparator	No kinesiotape, standard of care	Other: Kinesiotape placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kinesiotape placement	Other	Placement of kinesiotapes, using ligament techniques on the injured side of chest, focusing on the point of maximal pain.	control kinesiotape

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved spirometry tests	Improvement in lung function using spirometry	2 days

Secondary Outcomes

Measure	Description	Time Frame
Reduction in opioid consumption	Reduction in consumtion of opioid analgetic drugs	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral chest wall injury with multiple rib fracture (< 5 ribs)
Signed informed consent

Exclusion Criteria:

Minors
Pregnant women
Contraindications of using kinesiotapes
Contraindications to perform spirometry (lung function tests)
Inability to cooperate
Chest drains
Pneumothorax

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided