Trial Outcomes & Findings for Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture. (NCT NCT04683887)
NCT ID: NCT04683887
Last Updated: 2025-09-05
Results Overview
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
baseline and 1 week
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Tape Application
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
No tape application: Application of the tape will be not done
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tape Application
n=13 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=10 Participants
No tape application: Application of the tape not done
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=13 Participants
|
69 years
n=10 Participants
|
72 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
13 participants
n=13 Participants
|
10 participants
n=10 Participants
|
23 participants
n=23 Participants
|
|
Fractured arm
right
|
5 Participants
n=13 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=23 Participants
|
|
Fractured arm
left
|
8 Participants
n=13 Participants
|
7 Participants
n=10 Participants
|
15 Participants
n=23 Participants
|
|
Number of Participants with Heart diseases
|
0 Participants
n=13 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=23 Participants
|
|
Number of Participants with Kidney diseases
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Number of Participants with Respiratory diseases
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Number of Participants with Diabetes
|
1 Participants
n=13 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=23 Participants
|
|
Number of Participants with Hypertension
|
2 Participants
n=13 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=23 Participants
|
|
Thumb circumference at T0
|
7.1 cm
n=13 Participants
|
7.3 cm
n=10 Participants
|
7.1 cm
n=23 Participants
|
|
Circumference of the other 4 fingers (index, middle, ring and pinky) all side by side at T0
|
19.0 cm
n=13 Participants
|
18.0 cm
n=10 Participants
|
18.0 cm
n=23 Participants
|
|
Numerical Rating Scale (NRS) at T0
|
5.5 units on a scale
n=10 Participants • Pain degree at baseline measure was not recorded for 3 subjects of Tape application group and 5 subjects of No tape application group.
|
6.0 units on a scale
n=5 Participants • Pain degree at baseline measure was not recorded for 3 subjects of Tape application group and 5 subjects of No tape application group.
|
6.0 units on a scale
n=15 Participants • Pain degree at baseline measure was not recorded for 3 subjects of Tape application group and 5 subjects of No tape application group.
|
PRIMARY outcome
Timeframe: baseline and 1 weekthumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Outcome measures
| Measure |
Tape Application
n=12 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=7 Participants
No tape application: Application of the tape not done
|
|---|---|---|
|
Thumb Circumference
|
-0.2 cm
Interval -0.4 to 0.0
|
0 cm
Interval -0.1 to 0.4
|
PRIMARY outcome
Timeframe: baseline and 1 weekdifference 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
Outcome measures
| Measure |
Tape Application
n=12 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=7 Participants
No tape application: Application of the tape not done
|
|---|---|---|
|
Circumference of the Other 4 Fingers All Together
|
-0.5 cm
Interval -1.2 to 0.0
|
0.5 cm
Interval -0.6 to 0.8
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Pain degree at T1 data is missing for 6 subjects of Tape application group (3 of them also without assessment of NRS at baseline) and 4 subjects of No tape application group (3 of them also without assessment of NRS at baseline).
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.
Outcome measures
| Measure |
Tape Application
n=6 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=3 Participants
No tape application: Application of the tape not done
|
|---|---|---|
|
Pain Degree by Numerical Rating Scale (NRS)
|
2.5 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants that have been taken painkillers in the 4 hours prior to T1
Outcome measures
| Measure |
Tape Application
n=12 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=7 Participants
No tape application: Application of the tape not done
|
|---|---|---|
|
Number of Participants Taking Painkillers
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekNumber of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1
Outcome measures
| Measure |
Tape Application
n=12 Participants
Tape application: Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
|
No Tape Application
n=7 Participants
No tape application: Application of the tape not done
|
|---|---|---|
|
Number of Participants With OED Entry
|
0 Participants
|
0 Participants
|
Adverse Events
Tape Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Tape Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Massimo Guasconi
Azienda Unità Sanitaria Locale di Piacenza
Phone: +39-0523-303853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place