Edema Arm, Fracture; Wrist
Conditions
Keywords
tape, forearm cast
Brief 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.
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
Sponsors
Azienda Unita Sanitaria Locale di Piacenza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Data processing will be blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thumb Circumference | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Degree by Numerical Rating Scale (NRS) | 1 week | 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. |
| Number of Participants Taking Painkillers | 1 week | Number of Participants that have been taken painkillers in the 4 hours prior to T1 |
| Number of Participants With OED Entry | 1 week | Number of Participants with at least one OED entry for intolerance to plaster cast between T0 and T1 |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| No Tape Application No tape application: Application of the tape not done | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | Tape Application | No Tape Application | Total |
|---|---|---|---|
| Age, Continuous | 74 years | 69 years | 72 years |
| Circumference of the other 4 fingers (index, middle, ring and pinky) all side by side at T0 | 19.0 cm | 18.0 cm | 18.0 cm |
| Fractured arm left | 8 Participants | 7 Participants | 15 Participants |
| Fractured arm right | 5 Participants | 3 Participants | 8 Participants |
| Number of Participants with Diabetes | 1 Participants | 2 Participants | 3 Participants |
| Number of Participants with Heart diseases | 0 Participants | 1 Participants | 1 Participants |
| Number of Participants with Hypertension | 2 Participants | 3 Participants | 5 Participants |
| Number of Participants with Kidney diseases | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with Respiratory diseases | 0 Participants | 0 Participants | 0 Participants |
| Numerical Rating Scale (NRS) at T0 | 5.5 units on a scale | 6.0 units on a scale | 6.0 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Italy | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
| Thumb circumference at T0 | 7.1 cm | 7.3 cm | 7.1 cm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 7 |
| other Total, other adverse events | 0 / 12 | 0 / 7 |
| serious Total, serious adverse events | 0 / 12 | 0 / 7 |
Outcome results
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
Time frame: baseline and 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tape Application | Circumference of the Other 4 Fingers All Together | -0.5 cm |
| No Tape Application | Circumference of the Other 4 Fingers All Together | 0.5 cm |
Primary
Thumb Circumference
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Time frame: baseline and 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tape Application | Thumb Circumference | -0.2 cm |
| No Tape Application | Thumb Circumference | 0 cm |
Secondary
Number of Participants Taking Painkillers
Number of Participants that have been taken painkillers in the 4 hours prior to T1
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tape Application | Number of Participants Taking Painkillers | 1 Participants |
| No Tape Application | Number of Participants Taking Painkillers | 0 Participants |
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
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tape Application | Number of Participants With OED Entry | 0 Participants |
| No Tape Application | Number of Participants With OED Entry | 0 Participants |
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.
Time frame: 1 week
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tape Application | Pain Degree by Numerical Rating Scale (NRS) | 2.5 score on a scale |
| No Tape Application | Pain Degree by Numerical Rating Scale (NRS) | 3 score on a scale |