CClinicalTrials.gg
CompletedNCT04683887Updated Sep 5, 2025Results posted

Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.

An interventional study of Tape application in Edema Arm and Fracture; Wrist, sponsored by Azienda Unita Sanitaria Locale di Piacenza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Edema Arm
  • Fracture; Wrist

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Keywords

  • tape
  • forearm cast
03

In context

Wrist Fractures

323 studies on the registry are indexed under Wrist Fractures; 71 are open to participants now.

This study's enrollment of 23 is below the median of 64 across 261 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Tape application

    Device: Tape application

  • No intervention
    No tape application

Interventions

  • DeviceTape application

    Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast

06

What researchers measure

Primary outcomes

  1. Thumb Circumference

    thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)

    Time frame: baseline and 1 week

  2. 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

    Time frame: baseline and 1 week

Secondary outcomes

  1. 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.

    Time frame: 1 week

  2. Number of Participants Taking Painkillers

    Number of Participants that have been taken painkillers in the 4 hours prior to T1

    Time frame: 1 week

  3. Number of Participants With OED Entry

    Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1

    Time frame: 1 week

07

Results

Posted Aug 12, 2025

Participant flow

Participant flow — Overall Study
MilestoneTape ApplicationNo Tape Application
Started1310
Completed127
Not completed13

Outcome measures

PrimaryThumb Circumference

thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)

Time frame:
baseline and 1 week
Reported as:
Median · cm
Thumb Circumference
cmTape ApplicationNo Tape Application
Thumb Circumference-0.2 (-0.4 to 0)0 (-0.1 to 0.4)
PrimaryCircumference 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

Time frame:
baseline and 1 week
Reported as:
Median · cm
Circumference of the Other 4 Fingers All Together
cmTape ApplicationNo Tape Application
Circumference of the Other 4 Fingers All Together-0.5 (-1.2 to 0)0.5 (-0.6 to 0.8)
SecondaryPain 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.

Time frame:
1 week
Reported as:
Median · score on a scale
Pain Degree by Numerical Rating Scale (NRS)
score on a scaleTape ApplicationNo Tape Application
Pain Degree by Numerical Rating Scale (NRS)2.5 (1 to 3)3 (0 to 4)
SecondaryNumber of Participants Taking Painkillers

Number of Participants that have been taken painkillers in the 4 hours prior to T1

Time frame:
1 week
Reported as:
Count of participants · Participants
Number of Participants Taking Painkillers
ParticipantsTape ApplicationNo Tape Application
Number of Participants Taking Painkillers10
SecondaryNumber of Participants With OED Entry

Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1

Time frame:
1 week
Reported as:
Count of participants · Participants
Number of Participants With OED Entry
ParticipantsTape ApplicationNo Tape Application
Number of Participants With OED Entry00

Adverse events

Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tape Application0/12 (0%)0/12 (0%)0/12 (0%)
No Tape Application0/7 (0%)0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tape ApplicationNo Tape ApplicationTotal
Median74 (67 to 78)69 (55 to 72)72 (59 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Tape ApplicationNo Tape ApplicationTotal
Female7815
Male628
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Tape ApplicationNo Tape ApplicationTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Tape ApplicationNo Tape ApplicationTotal
Italy131023
Fractured arm
Fractured arm(Participants)Tape ApplicationNo Tape ApplicationTotal
right538
left8715
Number of Participants with Heart diseases
Number of Participants with Heart diseases(Participants)Tape ApplicationNo Tape ApplicationTotal
Count of participants011
Number of Participants with Kidney diseases
Number of Participants with Kidney diseases(Participants)Tape ApplicationNo Tape ApplicationTotal
Count of participants000
Number of Participants with Respiratory diseases
Number of Participants with Respiratory diseases(Participants)Tape ApplicationNo Tape ApplicationTotal
Count of participants000

5 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
    Piacenza, 29121, Italy
09

References and documents

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 34736885 ↗
  • Guasconi 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 documents

  • Protocol and statistical analysis plan · Feb 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04683887
Lead sponsor
Azienda Unita Sanitaria Locale di Piacenza
Responsible party
Massimo Guasconi (RN, MSN, Azienda Unita Sanitaria Locale di Piacenza) — Principal investigator
First posted
Dec 24, 2020
Start date
Jun 25, 2021
Primary completion
Mar 23, 2023
Completion
Mar 23, 2023
Results posted
Aug 12, 2025
Last update
Sep 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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