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.
Phase: NA
Conditions: Edema Arm, Fracture; Wrist
Sponsor: Azienda Unita Sanitaria Locale di Piacenza

 
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PROTOCOL 
 
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 
 
NCT number NCT04683887 
 
Document version 2.0 
Document date 15 feb 2022 
 
 

 
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INTRODUCTION 
Wrist fractures are a very common event affecting patients of all ages (Crowe et al., 2020) and are 
estimated to represent approximately 10-25% of all fractures (Geraci et al., 2011; Smeraglia et al., 
2016; Watson et al., 2018). These fractures are treated with closed reduction and forearm circular 
cast in 70-90% of cases (Letsch et al., 2003). There are several immobilization techniques, 
although there is no evidence identifying the best one in maintaining reduction. The forearm 
circular cast seems to be the best tolerated by patients (Okamura et al., 2018; Park et al., 2017; 
Peivandi et al., 2011). 
Wrist fracture patients often develop oedema (Knygsand-Roenhoej & Maribo, 2011) and the 
presence of plaster increases the risk (Dresing et al., 2017). In 2019, 17.4% of patients with wrist 
fractures treated with circular plaster cast at one Orthopedic Emergency Room (OER) of Northern 
Italy, had a second visit in OER for oedema, pain or "intolerance to the plaster cast". 
Kase has developed an adhesive elastic tape from 1973 to 1979 and marketed in 1982 with the 
name Kinesio tape (Wu et al., 2015). Since then, several authors have described this technique 
(Kase, 2005; Blow, 2015; Kumbrink et al., 2019) and several companies have started producing 
tapes with analogue characteristics. These devices are thin elastic stripes usually made of cotton, 
containing longitudinal interwoven elastic fibers and acrylic glue that is spread in a wavelike 
pattern. The material elasticity is approximately 130–140%, and the amount of traction used in its 
application to the skin influences the skin itself and various subcutaneous layers (Kase, 2005; 
Blow, 2015; Kumbrink et al., 2019). Taping technique is used to control the oedema, support of soft 
tissues, protect the joints and alleviate the heat produced by active inflammation. 
There are many studies in the literature that demonstrate the efficacy of adhesive elastic tape in 
reducing lymphoedema in different pathologic conditions. Oedema secondary to breast cancer 
treatment is reduced by taping application compared to untreated controls (Lipinska et al., 2007; 
Pajero Otero et al., 2019; Tantawy et al., 2019). A recent meta-analysis showed a positive effect in 
reducing lymphoedema (perimeter or volume) before versus after taping treatment, although no 
significant differences were found comparing taping with control group or other treatments 
(Kasawara et al., 2018). A meta-analysis concerning limb lymphedema, not necessarily due to 

 
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breast cancer, did not detect differences in the volume drained by the tape compared to the 
control, but found a decrease in symptoms related to oedema (Gatt et al., 2017). A single study 
appears to support the no-effect thesis (Ergin et al., 2019). 
Besides breast carcer, tape application has shown advantages after orthopedic surgery. The 
application of the tape seems to bring benefit in the post-operative period of knee arthroplasty, 
whether or not associated with manual lymphatic drainage (Donec & Kriščiūnas, 2014; Tornatore 
et al., 2020) and in the reduction of oedema in the knee after arthroscopy (Balki et al., 2016; 
Gülenç et al., 2019) however a trial does not recognize its effect in reducing oedema after shoulder 
arthroscopy (Gülenç et al., 2019). A systematic review supports the positive effects of the tape on 
post-operative oedema, although it recognizes some limitations including the small number of trials 
evaluated (Hörmann et al., 2020). One study reports good results in the control of oedema in 
patients treated with an Ilizarov type fixator (Białoszewski et al., 2009). 
Given the importance of oedema control and the lack of definitive evidence in the literature 
regarding the effectiveness of the adhesive elastic tape, we decided to perform this study in order 
to evaluate tape effectiveness in counteracting the oedema formation in the hand of wrist fractured 
adult patients treated with forearm circular cast. 
 
 
METHODS 
Aim 
The primary aim of our study is to evaluate whether the application of the tape with lymphatic 
technique to the fingers, both dorsal and volar, of wrist fractured patients treated with a forearm 
circular plaster cast is able to reduce the formation of hand oedema, compared to the untreated 
controls. Furthermore, we aim to assess the differences in pain and cast tolerability between the 
intervention group and the control group. 
 
Primary endpoints 

 
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(i) difference in the circumference of the thumb between baseline (T0) and 7-days follow-up (T1), 
and (ii) difference in the circumference of the remaining 4 fingers merged together, between T0 
and T1. 
Secondary endpoints 
(i) pain intensity at T0 and T1, (ii) analgesic use during the previous 4 hours at T0 and T1, and (iii) 
OER re-entry number for ―intolerance to the plaster cast‖. 
 
Design 
Our study is a randomized controlled superiority trial, with parallel design and blinded data 
processing, developed at OER of Local Health Unit of Piacenza. 
The ID NCT04683887 identify this study on clinicalrials.gov. 
 
Participant characteristics 
The patients’ eligibility criteria to participate in our study are described in Table 1. 
 
Sample size calculation 
The sample size was calculated using the GPower 3.1 Software, setting the following parameters: 
effect size: 0.4, error α = 0.05, power = 0.80 and allocation ratio = 1. 
The resulting sample size is 100 subjects per arm; the number of patients to be enrolled will be a 
total of 220 (110 per group), taking into account a 10% loss to follow up. The choice of medium 
effect size (0.4) was made based on feasibility and available literature (Gülenç et al., 2019; Pajero 
Otero et al., 2019; Tantawy et al., 2019) despite the absence of similar studies for pathology/type 
of intervention/primary endpoint. 
 
Setting 
Patient enrolment, execution of the fracture reduction maneuver, application of the plaster cast, 
application of the tape for the investigational treatment patient group, and endpoint T0 
measurements will take place at the OER service of Local Health Unit of Piacenza. On day 7 the 

 
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tapes will be removed and endpoint T1 measurements will be assessed at the Orthopedics and 
Traumatology outpatient clinic. 
 
Preliminary procedures and nurses’ training 
Before the enrolment of the first patient, all OER nurses will be trained for the tape application by a 
certified instructor. 
All OER orthopedic doctors and nurses are trained and skilled in the closed reduction technique 
and forearm circular cast application. The closed reduction technique, done manually by three 
operators, and circular cast application are performed as described in Dresing et al. (2017). 
 
Patients’ enrolment 
After having performed the necessary radiographic investigations and verified the presence of all 
inclusion criteria and the absence of exclusion criteria, complete oral and written information about 
the study will be given to each patient by OER nurses and physicians. A reflection period will be 
guaranteed to the patient during the waiting time before the control X-ray after reduction 
procedure. 
Enrolment will be effective as soon as the patient has signed the consent form. We will then assign 
him/her to the intervention or control group after a telephone call to the Data Analysis Manager, as 
described in the following section. 
 
Randomization, blind and control 
We will generate the randomization list through the program called "Random Number Generator", 
available at https://stattrek.com/statistics/random-number-generator.aspx. The randomization will 
be simple with 1:1 allocation. The randomization list, known only to the Data Analysis Manager not 
involved in the clinical evaluation of patients, will be implemented and hidden inside a specific file 
protected by a password to prevent identification of the patient. We will assign the enrolled patients 
to group 0 or 1 according to the list by a telephone contact between Investigators and Data 
Analysis Manager. 

 
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The data-analyzing Researcher will not know which of the two groups will be the intervention nor 
the control one, to guarantee the blind. The Investigators are not allowed to collect data in a blind 
way due to the nature of study intervention. 
We decided not to apply any type of alternative strip to the control group. Even if positioned without 
lymphatic technique, the tape would maintain its elastic properties and we cannot exclude that it 
may still have an effect. The application of a strip with properties different from the tape on one 
side would still have the adhesive effect induced by the glue-skin interaction, stimulating muscle 
function (Blow, 2015; Frignani, 2017; Zimaglia, 2014), but on the other hand, having a different 
elasticity from that of the tape, could reduce the range of motion (ROM) of the fingers (Frignani, 
2017) and potentially could increase the risk of developing oedema in the control group. 
 
Outcome evaluation details 
OER nurses will evaluate the extent of oedema in the fracture-homolateral hand by measuring the 
circumference at the base of the 1st phalanx of the 1st finger and at the base of the 1st phalanx of 
the remaining 4 fingers merged together both at T0 and T1. The number of re-entries in OER 
between T0 and T1 will be registered. Furthermore, we will measure the intensity of pain with the 
Numerical Rating Scale (NRS) (Artioli et al., 2016; Peate et al., 2018) both at T0 and T1. At T0, the 
pain will be assessed before the possible administration of local anesthetic, while we do not expect 
differences between the intervention and the control group. Finally, the eventually analgesic use 
during the previous 4 hours will be recorded both at T0 and T1. 
 
Procedure 
An alphanumeric code will identify each patient in the case report form (CRF) and in the electronic 
database used for the analyzes, in order to guarantee pseudonymization. 
We will report in the CRF the variables described in the Table 2. 
Once the fracture reduction maneuver has been performed and the immobilization performed in a 
plaster cast, if the patient belongs to the intervention group, we will apply the tape only to the 
fingers of the hand with a lymphatic technique (Figure 2). We will not extend the application to the 

 
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metacarpals even if it would increase the surface of action, because portions of the tape will 
remain under the plaster, hiding possible skin reactions to the glue. Moreover, the tape application 
up to the metacarpals, inevitably performed before cast application, will increase the risk of 
detaching during the plaster wrap. 
Blow (2015) suggests that the tape application needs to be proximal to the plaster cast. However, 
this indication is not supported by the literature. Other authors apply tape on the area that will 
probably form oedema (Donec, et al.,2014). Therefore, we believe that tape application on hand 
fingers is the most appropriate for achieving the objectives of this study. 
The tape available at the Local Health Unit of Piacenza is the Leukotape K® by Essity, winner of 
the INTERCENTER AVEN tender for the supply of this type of medical device. 
CRFs will be kept in OER until follow-up, so that any re-attendances can be noted. 
 
Follow up 
Even though tape results could be seen after 2-3 days, we choose to collect T1 variables (as 
previously described) at day 7 in order to avoid possible bias in the re-entry evaluation. The 7-day 
follow-up will be concomitant with the radiographic fracture control provided by organization 
procedure. 
The completed CRFs will be delivered to the Researcher who will carry out the data analysis. 
 
Statistical analysis 
We will describe the general characteristics of the two groups. We will evaluate the effectiveness of 
randomization through the χ2 test, for categorical variables, and the t-test, for continuous variables. 
Intervention group versus control group analyses will be performed by comparing the respective 
mean of: the T0-T1 differences of circumference of both thumb (i) and the other 4 fingers (ii), the 
pain NRS score at T1(iii), and the number of OER re-entries (v), by t-test for independent groups 
(after verifying the normality of the distributions with the Shapiro Wilk test).  
All analyses will be performed on an Intention-To-Treat principles: all randomized patients will be 
analyzed in the arm they were allocated by randomization. Only screening failures and patients 

 
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who refuse before the treatment start would be excluded. In the event of tape detachment in the 
first 48 hours after T0 and/or impossibility to evaluate study endpoints, missing data will be 
substituted by multiple imputation. 
We will perform all analyzes using 2-tailed tests and consider significant a p value <0.05. We will 
report all analyzes according to the international guidelines for RCTs (Boutron et al., 2017). 
 
 

 
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TABLES 
Table 1: Inclusion and exclusion criteria of study population. 
Inclusion criteria 
Exclusion criteria 
- Age ≥   18 years. 
- Bilateral wrist fracture (because these patients 
may have reduced motility increasing the risk of 
oedema formation and to avoid the risk of 
double counting bias). 
- 
Growth 
plate 
closure 
at 
radiographic 
examination (in order to exclude any epiphyseal 
detachments). 
- Multiple fractures. 
- Unilateral distal radius fracture associated or 
not with ulnar styloid fracture (Colles or 
Goyrand types). 
- Polytrauma. 
- Need of closed reduction and immobilization 
with a forearm circular cast (Figure 1). 
- Previous plegia/paralysis of the fractured limb. 
- Signed informed consent. 
- Previous lymphoedema of the fractured limb. 
 
- Access to OER 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 (strip glue).* 

 
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- Solid neoplasm.* 
 
* Further exclusion criteria introduced following advices of Blow and Kumbrink although to date 
there are no absolute contraindications to the application of elastic tapes (Blow, 2015; Kumbrink et 
al., 2019). 
 
 

 
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Table 2: Variables of study CRF and study timepoints.  
Variable name 
Unit 
of 
measurement 
or 
possible categories 
T0 (day1) 
T1 (day7) 
Subject code 
N/A 
X 
 
Gender 
Male/Female 
X 
 
Age 
Years 
X 
 
Heart disease 
Presence/Absence 
X 
 
Kidney pathologies 
Presence/Absence 
X 
 
Respiratory diseases 
Presence/Absence 
X 
 
Diabetes 
Presence/Absence 
X 
 
Hypertension 
Presence/Absence 
X 
 
Assigned group 
0/1 
X 
 
Fractured limb 
Right/Left 
X 
 
1st finger circumference 
Cm 
X 
X 
Circumference of the remaining 4 fingers 
merged together 
Cm 
X 
X 
NRS 
0-10 
X 
X 
Analgesic use during the previous 4 hours  
Yes/No 
X 
X 
Accidental removal in the 48 hours after T0 Presence/Absence 
 
X 
Accidental removal 
Presence/Absence 
 
X 
OER re-attendance between T0 and T1 
Natural number 
 
X 
 
 

 
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FIGURE LEGENDS 
 
Figure 1. CONSORT flowchart modified for Randomized Trials of Nonpharmacologic Treatments 
(Boutron et al., 2017) 
 
Figure 2. Tape application: a. lateral view, b. sight fly, c. dorsal view 
 

 
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FIGURES 
 
Figure 1 
 
 

 
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Figure 2.