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

Primary Purpose

Edema Limbs

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

neuromuscolar tape

antigravity arm position

About this trial

This is an interventional treatment trial for Edema Limbs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Maria Enrica AntoniucciRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treated group

control group

Arm Description

neuromuscolar tape application

antigravity position

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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

muscle strength measure

measurement of the handheld gripping force by means of a dynamometer

Full Information

NCT ID

NCT04785508

First Posted

February 17, 2021

Last Updated

March 5, 2021

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT04785508

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 15, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edema Limbs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treated group

Arm Type

Experimental

Arm Description

neuromuscolar tape application

Arm Title

control group

Arm Type

Active Comparator

Arm Description

antigravity position

Intervention Type

Device

Intervention Name(s)

neuromuscolar tape

Intervention Description

neuromuscalar tape application in decompression technique (hand and arm)

Intervention Type

Behavioral

Intervention Name(s)

antigravity arm position

Intervention Description

antigravity arm position

Primary Outcome Measure Information:

Title

circumference's change of index finger, metacarpus, wrist, mid forearm, elbow and upper arm

Description

measure tissue edema change by circumference change in specific site of the limb ( index finger, metacarpus, wrist, mid forearm, elbow and upper arm)

Time Frame

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 Measure Information:

Title

measurement of the intensity of pain

Description

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)

Time Frame

Measure every day for the 3 days of treatment, before application of tape

Title

movement ability of wrist, hand and arm

Description

measure angle variation in pronosupination and flexion extension, ulnar and radial deviation of the wrist with articular goniometer

Time Frame

measure every day for the 3 days of treatment, before application of tape

Title

muscle strength measure

Description

measurement of the handheld gripping force by means of a dynamometer

Time Frame

measure every day for the 3 days of treatment, before application of tape

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Enrica Antoniucci, MD

Phone

+ 393335492584

mariaenrica.antoniucci@policlinicogemelli.it

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Enrica Antoniucci

mariaenrica.antoniucci@policlinicogemelli.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Enrica Antoniucci, MD

Organizational Affiliation

FPG IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maria Enrica Antoniucci

City

Roma

ZIP/Postal Code

00136

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Enrica Antoniucci, MD

First Name & Middle Initial & Last Name & Degree

Maria Enrica Antoniucci

Phone

+ 393335492584

mariaenrica.antoniucci@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

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

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