Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
Primary Purpose
Chest Wall Injury
Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Kinesiotape placement
Sponsored by
About this trial
This is an interventional treatment trial for Chest Wall Injury
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
Sites / Locations
- University Medical Centre LjubljanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
kinesiotape
control
Arm Description
Placement of kinesiotapes, using ligament techniques on the injured side of chest, focusing on the point of maximal pain.
No kinesiotape, standard of care
Outcomes
Primary Outcome Measures
Improved spirometry tests
Improvement in lung function using spirometry
Secondary Outcome Measures
Reduction in opioid consumption
Reduction in consumtion of opioid analgetic drugs
Full Information
NCT ID
NCT05753982
First Posted
February 22, 2023
Last Updated
March 15, 2023
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT05753982
Brief Title
Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
Official Title
Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Wall Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
kinesiotape
Arm Type
Experimental
Arm Description
Placement of kinesiotapes, using ligament techniques on the injured side of chest, focusing on the point of maximal pain.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
No kinesiotape, standard of care
Intervention Type
Other
Intervention Name(s)
Kinesiotape placement
Intervention Description
Placement of kinesiotapes, using ligament techniques on the injured side of chest, focusing on the point of maximal pain.
Primary Outcome Measure Information:
Title
Improved spirometry tests
Description
Improvement in lung function using spirometry
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Reduction in opioid consumption
Description
Reduction in consumtion of opioid analgetic drugs
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marko Žličar, MD
Phone
+38615224553
Email
marko.zlicar@kclj.si
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARKO ZLICAR
Phone
+38615224553
Email
marko.zlicar@kclj.si
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
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