Effects Neuromuscular Taping Technique on Upper Limbs Edema in Cardiac Surgery Patients

This study aims to verify the efficacy of the decompression technique of neuromuscular taping on cardiac surgery patients in whom edema of the upper limbs occurs due to post-operative water overload.

Study Overview

• Status: Recruiting
• Conditions: Edema Limbs
• Intervention / Treatment: Device: neuromuscolar tape; Behavioral: antigravity arm position

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Enrica Antoniucci, MD; Phone Number: + 393335492584; Email: mariaenrica.antoniucci@policlinicogemelli.it
• Study Contact Backup: Name: Maria Enrica Antoniucci; Email: mariaenrica.antoniucci@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00136
    • Recruiting
    • Maria Enrica Antoniucci
    • Contact: Maria Enrica Antoniucci, MD
    • Contact: Maria Enrica Antoniucci; Phone Number: + 393335492584; Email: mariaenrica.antoniucci@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cardiac surgery patients with postoperative edema of the upper limbs due to water overload

Exclusion Criteria:

• absence of edema,
• previous mastectomy and lymphadenectomy,
• surgery or fractures or infection of the upper limb,
• previous or current deep vein thrombosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treated group; neuromuscolar tape application	Device: neuromuscolar tape; neuromuscalar tape application in decompression technique (hand and arm)
Active Comparator: control group; antigravity position	Behavioral: antigravity arm position; antigravity arm position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
circumference's change of index finger, metacarpus, wrist, mid forearm, elbow and upper arm	measure tissue edema change by circumference change in specific site of the limb ( index finger, metacarpus, wrist, mid forearm, elbow and upper arm)	measure in millimeter on first postoperative day: before application of tape; and then, every day for the first 3 days, after tape removing, and before the new application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of the intensity of pain	measurement of the intensity of pain during mobilization of fingers, wrist and arm using a VAS scale( 0 is no pain and 10 is the worst possible pain)	Measure every day for the 3 days of treatment, before application of tape
movement ability of wrist, hand and arm	measure angle variation in pronosupination and flexion extension, ulnar and radial deviation of the wrist with articular goniometer	measure every day for the 3 days of treatment, before application of tape
muscle strength measure	measurement of the handheld gripping force by means of a dynamometer	measure every day for the 3 days of treatment, before application of tape

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Maria Enrica Antoniucci, MD, FPG IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2672

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No