Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tape application | Experimental |
| |
| No tape application | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tape application | Device | Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thumb Circumference | thumb circumference difference between baseline (T0) and follow-up on day 7 (T1) | 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 | baseline and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza | Piacenza | 29121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34736885 | Background | 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. | |
| 38261469 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | No Tape Application | No tape application: Application of the tape will be not done |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | No Tape Application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thumb Circumference | thumb circumference difference between baseline (T0) and follow-up on day 7 (T1) | Posted | Median | Inter-Quartile Range | cm | baseline and 1 week |
|
1 week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Massimo Guasconi | Azienda Unità Sanitaria Locale di Piacenza | +39-0523-303853 | m.guasconi2@ausl.pc.it |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2022 | Jul 21, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Data processing will be blinded
| Number of Participants Taking Painkillers |
Number of Participants that have been taken painkillers in the 4 hours prior to T1 |
| 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 | 1 week |
| 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. |
No tape application: Application of the tape not done
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fractured arm | Count of Participants | Participants |
|
| Number of Participants with Heart diseases | Count of Participants | Participants |
|
| Number of Participants with Kidney diseases | Count of Participants | Participants |
|
| Number of Participants with Respiratory diseases | Count of Participants | Participants |
|
| Number of Participants with Diabetes | Count of Participants | Participants |
|
| Number of Participants with Hypertension | Count of Participants | Participants |
|
| Thumb circumference at T0 | Median | Inter-Quartile Range | cm |
|
| Circumference of the other 4 fingers (index, middle, ring and pinky) all side by side at T0 | Median | Inter-Quartile Range | cm |
|
| Numerical Rating Scale (NRS) at T0 | Numerical Rating Scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". | Pain degree at baseline measure was not recorded for 3 subjects of Tape application group and 5 subjects of No tape application group. | Median | Inter-Quartile Range | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | cm | baseline and 1 week |
|
|
|
| Secondary | 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 1 week |
|
|
|
| Secondary | Number of Participants Taking Painkillers | Number of Participants that have been taken painkillers in the 4 hours prior to T1 | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Number of Participants With OED Entry | Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1 | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Tape Application | No tape application: Application of the tape not done | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided