Edema LimbsNCT04785508
Effects Neuromuscular Taping Technique on Upper Limbs Edema in Cardiac Surgery Patients
A study testing neuromuscolar tape and antigravity arm position in people with Edema Limbs, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edema Limbs
- What is being tested?
- neuromuscolar tape and antigravity arm position
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac surgery patients with postoperative edema of the upper limbs due to water overload
Who cannot join
- absence of edema,
- previous mastectomy and lymphadenectomy,
- surgery or fractures or infection of the upper limb,
- previous or current deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
Maria Enrica Antoniucci contact
Italy1 site, 1 recruiting
- Recruiting
Maria Enrica Antoniucci
Roma, 00136
Maria Enrica Antoniucci, MD
Maria Enrica Antoniucci, + 393335492584, mariaenrica.antoniucci@policlinicogemelli.it
About this study
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.
- Conditions
- Edema Limbs
- Being tested
- neuromuscolar tape, antigravity arm position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscolar tapeDevice
neuromuscalar tape application in decompression technique (hand and arm)
antigravity arm positionBehavioural
antigravity arm position
| Study group | Role | What they receive |
|---|---|---|
| treated group | Experimental | neuromuscolar tape application Receives: Device: neuromuscolar tape |
| control group | Active comparator | antigravity position Receives: Behavioral: antigravity arm position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (3)
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)
Measured: 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
Measured: 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
Measured: measure every day for the 3 days of treatment, before application of tape
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start15 Feb 2021
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LimbsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoniucci Maria Enrica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Maria Enrica Antoniucci, MD, Principal investigator, FPG IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785508
- Sponsor's protocol ID
- 2672
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Neuromuscular Taping Technique on Upper Limbs Edema in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT04785508
- Acronym / sponsor ID
- 2672
- Conditions
- Edema Limbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated group | Experimental | Device: neuromuscolar tapeneuromuscolar tape application |
| control group | Active comparator | Behavioral: antigravity arm positionantigravity position |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery patients with postoperative edema of the upper limbs due to water overload
Key exclusion criteria (4 listed)
- absence of edema,
- previous mastectomy and lymphadenectomy,
- surgery or fractures or infection of the upper limb,
- previous or current deep vein thrombosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscolar tapeneuromuscalar tape application in decompression technique (hand and arm) | Device | treated group |
| antigravity arm positionantigravity arm position | Behavioural | control group |
Primary outcome
circumference's change of 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.
measure tissue edema change by circumference change in specific site of the limb ( index finger, metacarpus, wrist, mid forearm, elbow and upper arm)
3 secondary outcomes
measurement of the intensity of pain
Time frame: Measure every day for the 3 days of treatment, before application of tape
movement ability of wrist, hand and arm
Time frame: measure every day for the 3 days of treatment, before application of tape
muscle strength measure
Time frame: measure every day for the 3 days of treatment, before application of tape
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Enrica Antoniucci contact
Maria Enrica Antoniucci, MD principal investigator
FPG IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscolar tape and antigravity arm position in people with Edema Limbs, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Enrica Antoniucci, MD (+ 393335492584, mariaenrica.antoniucci@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circumference's change of 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.