Edema ArmNCT04683887
Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.
A study testing Tape application in people with Edema Arm and Fracture; Wrist, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema Arm, Fracture; Wrist
- What is being tested?
- Tape application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2021to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with growth plates closed on radiographic examination
- Unilateral distal radius fracture associated or not with ulnar styloid fracture
- Wrist fracture requiring bloodless reduction and immobilization with a forearm cast
Who cannot join
- Patients with multiple fractures
- Polytrauma patients
- Patients with previous plegia / paralysis of the fractured limb
- Patients with previous lymphedema of the fractured limb
- Patients with access to the OED during the night when the organization does not guarantee the presence of 2 nurses
- Wounds or abrasions in the area of application of the tape
Show all 11Show fewer
- Acute thrombosis (upper limb veins)
- Scars not perfectly healed in the area of application of the tape
- Dermatitis, psoriatic manifestations or erythema in the area of application of the tape
- Known allergy to acrylic (patch glue)
- Solid neoplasms
Trial locations and contacts
1 site in 1 country.
Italy1 site
Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
Piacenza, 29121
About this study
Official title: Randomized and Controlled Prospective Study on Use of the Adhesive Elastic Tape to Control Hand Edema in Patients With a Wrist Fracture Treated With Forearm Plaster.
Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. In 2019, 17.4% of wrist fractured patients treated with a plaster cast at the Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza had a second access to the OED for edema, pain or "intolerance to the plaster cast ".
In literature, there are several studies that demonstrate the effectiveness of adhesive elastic tape for edema control, mostly lymphedema secondary to breast cancer or post-operative edema after knee arthroplasty, although a definitive evidence is still needed.
With this trial, the investigators aim to evaluate the tape effectiveness in counteracting hand edema formation in wrist fractured adult patients treated with forearm cast.
- Conditions
- Edema Arm, Fracture; Wrist
- Being tested
- Tape application
- Keywords
- tape, forearm cast
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tape applicationDevice
Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
| Study group | Role | What they receive |
|---|---|---|
| Tape application | Experimental | Not described Receives: Device: Tape application |
| No tape application | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thumb Circumference
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Measured: baseline and 1 week
Circumference of the Other 4 Fingers All Together
difference between T0 and T1 in the circumference of the other 4 fingers (index, middle, ring and pinky) all side by side, measured at the first phalanx
Measured: baseline and 1 week
Secondary outcomes (3)
Pain Degree by Numerical Rating Scale (NRS)
pain degree by NRS at T1. The NRS is an 11-point scale used to assess pain intensity, ranging from 0 to 10. A score of 0 indicates no pain, while 10 represents the worst pain imaginable. The NRS is a simple and quick method for patients to self-report their pain level.
Measured: 1 week
Number of Participants Taking Painkillers
Number of Participants that have been taken painkillers in the 4 hours prior to T1
Measured: 1 week
Number of Participants With OED Entry
Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start25 Jun 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edema ArmStudies of the same condition, open and under way.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Guasconi, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683887
- Sponsor's protocol ID
- TapeK_Gesso_ABM_PSO
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2020
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guasconi M, Riboni DZ, Granata C, Bolzoni M, Beretta M, Mozzarelli F, Maniscalco P. Randomised controlled prospective study of the use of adhesive elastic tape for the control of hand oedema in patients with a wrist fracture treated in a cast: a study protocol. Int J Orthop Trauma Nurs. 2022 Feb;44:100881. doi: 10.1016/j.ijotn.2021.100881. Epub 2021 Jun 19.
PubMed 34736885Guasconi M, Zilli Riboni D, Civardi A, Bolzoni M, Granata C, Beretta M, Genovese A, Mozzarelli F, Quattrini F, Maniscalco P. The use of adhesive elastic tape for hand oedema control in patients with a wrist fracture treated in a cast: A pilot study. Int J Orthop Trauma Nurs. 2024 May;53:101059. doi: 10.1016/j.ijotn.2023.101059. Epub 2023 Oct 22.
PubMed 38261469
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Prospective Study on Use of the Adhesive Elastic Tape to Control Hand Edema in Patients With a Wrist Fracture Treated With Forearm Plaster.
- ClinicalTrials.gov ID
- NCT04683887
- Acronym / sponsor ID
- TapeK_Gesso_ABM_PSO
- Conditions
- Edema Arm, Fracture; Wrist
- Keywords
- tape, forearm cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. In 2019, 17.4% of wrist fractured patients treated with a plaster cast at the Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza had a second access to the OED for edema, pain or "intolerance to the plaster cast ".
In literature, there are several studies that demonstrate the effectiveness of adhesive elastic tape for edema control, mostly lymphedema secondary to breast cancer or post-operative edema after knee arthroplasty, although a definitive evidence is still needed.
With this trial, the investigators aim to evaluate the tape effectiveness in counteracting hand edema formation in wrist fractured adult patients treated with forearm cast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tape application | Experimental | Device: Tape application |
| No tape application | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with growth plates closed on radiographic examination
- Unilateral distal radius fracture associated or not with ulnar styloid fracture
- Wrist fracture requiring bloodless reduction and immobilization with a forearm cast
Key exclusion criteria (11 listed)
- Patients with multiple fractures
- Polytrauma patients
- Patients with previous plegia / paralysis of the fractured limb
- Patients with previous lymphedema of the fractured limb
- Patients with access to the OED during the night when the organization does not guarantee the presence of 2 nurses
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 |
|---|---|---|
| Tape applicationApplication of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast | Device | Tape application |
Primary outcome
Thumb Circumference
Time frame: baseline and 1 week
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Circumference of the Other 4 Fingers All Together
Time frame: baseline and 1 week
difference between T0 and T1 in the circumference of the other 4 fingers (index, middle, ring and pinky) all side by side, measured at the first phalanx
3 secondary outcomes
Pain Degree by Numerical Rating Scale (NRS)
Time frame: 1 week
Number of Participants Taking Painkillers
Time frame: 1 week
Number of Participants With OED Entry
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34736885Guasconi M, Riboni DZ, Granata C, Bolzoni M, Beretta M, Mozzarelli F, Maniscalco P. Randomised controlled prospective study of the use of adhesive elastic tape for the control of hand oedema in patients with a wrist fracture treated in a cast: a study protocol. Int J Orthop Trauma Nurs. 2022 Feb;44:100881. doi: 10.1016/j.ijotn.2021.100881. Epub 2021 Jun 19.
- Derived from this study: PubMed 38261469Guasconi M, Zilli Riboni D, Civardi A, Bolzoni M, Granata C, Beretta M, Genovese A, Mozzarelli F, Quattrini F, Maniscalco P. The use of adhesive elastic tape for hand oedema control in patients with a wrist fracture treated in a cast: A pilot study. Int J Orthop Trauma Nurs. 2024 May;53:101059. doi: 10.1016/j.ijotn.2023.101059. Epub 2023 Oct 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tape application in people with Edema Arm and Fracture; Wrist, run by Azienda Unita Sanitaria Locale di Piacenza 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 5 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thumb Circumference (time frame: baseline and 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683887, which also lists 2 linked publications.
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 5 Sep 2025.