COMPARISON OF BANDAGE IN HAND EDEMA

Aims of the study

This study has one primary aim and two secondary aims. The primary aim is to find out which bandage is more effective in the treatment of hand edema in orthopaedic patients. The short-stretch bandage will be compared with the high-stretch bandage, with the latter being more commonly used. The effectiveness of the bandage in the treatment of hand edema is demonstrated by its ability to reduce the volume of the affected hand. The first secondary objective is to investigate the patients' subjective perception regarding the impact that hand edema and the application of the bandage may have on the function and aesthetic appearance of the hand, performance of ADLs and quality of life. The study is carried out by giving the participating patients a specific semi-structured interview. The second secondary objective is to measure the passive joint ROM of the wrist and the five fingers of the hand: metacarpophalangeal, proximal interphalangeal, distal interphalangeal. This is performed to assess any improvement in passive joint ROM between before and after application of the bandages, which should follow the reduction in hand edema caused by the bandages. The "conical" shape of the finger is well suited to evaluate the effectiveness of a bandage. If the tension of the bandages is the same, distal pressure is greater than the proximal pressure (Laplace's law: the pressure is inversely proportional to the radius of curvature and proportional to the tension). This reduces the possibility of error errors caused by incorrect application of the bandage. In addition, the movement of the fingers and hand, required for the patients in the study by performing specific exercise program at home, in addition to promoting pressure peaks that favor fluid advancement, allows normalization of the tension of the coils of the bandage.

Study design

The identified study design is a randomized, controlled trial with cross-over (RCT with cross-over). The study is multicenter and has no commercial purpose (no profit). Patients with hand edema who meet the inclusion and exclusion criteria, will be included and then randomized into the two study groups.

Randomization

Patients in this study will be randomized in a 1:1 ratio, by simple randomization, into the following two groups: Group A - experimental (short-stretch bandage for the first 24 hours, high-stretch bandage for the next 24 hours); Group B - control (high-stretch bandage for the first 24 hours, short-stretch bandage for the next 24 hours).

The randomization procedure is performed with the REDCap platform.

Cross-over

This study is a a cross-over as each patient receives both types of bandages, regardless of the group to which they belong. The cross-over makes it possible to reduce the sample size, and still obtain statistically significant results. The only thing that changes between the experimental group and the control group, is the timing of the application of the two different types of bandage: the materials used, the procedures and the assessments performed are the same in both groups.

Study blinding

This study is blinded because the patient and the outcome assessor are blinded to the type of bandage used (high or short stretch) and therefore the group to which the patient belongs (experimental or control). The patient does not know what type of bandage is being applied, as the physiotherapist applying the bandage does not tell the patient what type of bandage is being used. The endpoint evaluator also does not know what type of bandage the patient is wearing, as he is not present when the patient is bandaged and performs his assessment with the patient's unattached hand. In fact, each patient in the study is explicitly instructed by their physiotherapist to remove the bandage on their own approximately 30 minutes before the examination. In addition, both the patient and the endpoint evaluator are kept separate from the randomization process and the patient group (Group A or B).

Study setting

This study is multicenter and the participating centers are:

* UOC of Functional Recovery and Rehabilitation of the Alto Vicentino Hospital. * Professional clinic "Elena Lanfranchi". * Fisiomed Polyclinic.

Endpoints of the study

1. Volume of the edematous hand, measured by Valgrado volumetry. 2. Passive ROM (range of motion) of the wrists and the five fingers of the edematous hand (metacarpophalangeal and interphalangeal joints). 3. Scores of the different areas assessed by the semi-structured interview.

Variables of the study

The dependent variables correspond to the endpoints listed above. The independent variable is represented by the type of hand bandage applied.

Protective factors

The protective factors are represented by:

* The person performing the treatments is different from the person performing the assessment. * The person carrying out the examination does not know what kind of bandage the patient is wearing. * The patient himself does not know what type of bandage he was wearing. * The bandages are applied in the same way in both groups of the study (experimental and control group).

Risk factors

Each unit in the sample receives two different bandages, one after the other, without a time break in between. A possible risk factor is that the first dressing applied may cause a greater reduction in hand volume than the second dressing applied (which is applied to a hand that has already experienced a reduction in edema from the previous dressing).

No washout in the study

The time-dependent reduction in pressure exerted by short-stretch bandages is a well-known phenomenon and is related to the decrease in volume of the bandaged body part and the partial relaxation of the bandages. (Damstra R.J., Brouwer E.R. et al.) This significant and rapid drop in pressure with short-stretch bandages means that the bandage must be replaced daily in the initial phase of compression therapy. (Todd M.) This information justifies the lack of need to allow a certain amount of time to elapse between the application of the two bandages in the present study (wash-out). By the time the second bandage is applied, the first bandage has already had its effect and can be considered ineffective. We also consider this reasonable because the pressure exerted by short-stretch bandages is already reduced by 1/3 30 minutes after application, as mentioned in this study (Damstra R.J., Brouwer E.R. et al). The main reason for this rapid reduction in the pressure exerted by short-stretch bandages is the (therapeutic and intentional) reduction in the volume of the bandaged body part, which is achieved immediately after application of the bandage in both lymphoedema- affected and healthy subjects.

Bias

* The treatments (bandages) are performed by different people. This bias was eliminated because the methods for applying the bandages were exchanged before the start of the study and all experimenters underwent practical training. In addition, an explanatory video on the correct method of dressing application was produced and distributed to all experimenters. * Presence of patients with edema of different origin (traumatic or surgical), in the acute phase (within 6 months of trauma). However, the literature studies show a similar heterogeneity of the sample with edema of different etiologies. In addition, edema is classified not so much by etiology, but rather by whether it is acute (within 6 months of onset) or chronic (more than 6 months after onset).

* Selection bias: the differences found between the experimental and control groups are reduced by carrying out a randomized, controlled, cross-over study. * Measurement bias: the different centers participating in the study use different measurement instruments but meeting the same standards. In particular, the scale used is a high-resolution and high-capacity scale: resolution of 1 g and capacity of 6 kg. The brand of the instrument may vary but not its characteristics, which are standardized among the different centers participating in the study. * Performance bias: The patient and the endpoint evaluator are blind to the type of bandage the patient receives. The investigator, on the other hand, knows which bandage is used because he applies it himself.

DATA COLLECTION TOOLS

Exercises suggested to the patients in the study

Considering the data in the literature, it is clear that the positive effects of active exercise on edema cannot be overlooked and that active exercise must be an integral part of treatment. In fact, each patient in the present study will be educated and trained in the correct execution of three active mobilization exercises for the bandaged hand to be performed at home while wearing the bandage. The three exercises in question are selected by the patient's physiotherapist from the exercises listed in the exercise program developed for this study. These three exercises are those that are most appropriate based on the patient's clinical characteristics. During the 24 hours in which the first bandage is applied and during the 24 hours in which the second bandage is applied, each patient performs the same 3 exercises chosen for him by his physiotherapist, regardless of the type of bandage, and at the same dosage. Therefore, the dosage to be respected by the patients when performing the exercises is the same on the different days of the study and is the same for all patients: 10 repetitions for each exercise, performing all the selected exercises at least 3 times per day, as suggested by (Mackin E.J.). To encourage compliance with the treatment and correct execution of the exercises, each patient receives a booklet with illustrations of the proposed exercises. This booklet was created by the experimenter specifically for this study and contains exercises that involve active mobilization of all joints of the fingers and hand as suggested by (LaStayo P., Winter K. et al) and (Skirven T.M., Osterman A.L. et al). In the booklet, each exercise is described in simple terms and accompanied by a photograph on the side demonstrating its execution.

Finally, for each patient in the study, the performance of the exercises at home is examined during the semi-structured interview, which includes specific questions on this topic.

Valgrado volumetry

Valgrado volumetry is a technique for measuring hand volume that uses Archimedes' principle and takes less time than the classic volumetric method. In Valgrado volumetry, the hand is immersed in a vessel filled with water (not to the brim), which is placed on a precision scale connected to a PC that processes the data directly. This instrument minimizes measurement errors due to limb movements. The instrument used in the present study is a core balance with a capacity of 6 kg and a sensitivity of 1 gram. The results of this study (Hughes S., Lau J.) suggest that Valgrado volumetry has the same accuracy and precision as the classical volumetric method, and even has the potential to provide more accurate and precise results.

In addition, Valgrado volumetry is faster than the classical volumetric method: a single measurement of hand volume with the classical volumetric method takes about 45 seconds (Pellachia G.), while with Valgrado volumetry it takes about 16 seconds. Consequently, this latter technique offers the possibility of increasing the number of volumetric measurements that can be performed in the same session, thus increasing the statistical value of the assessment. Before performing volumetry, the hand to be examined must first be properly washed and dried, and the limit of immersion in water must be determined. The hand to be examined is then immersed in water up to this limit, taking care not to touch the bottom and sides of the container.

In the present study, the boundary of hand immersion in water is identified as the imaginary line connecting the spinous processes of the radius and ulna. The following procedure is used

• Range Of Motion (ROM) [Time frame: Wrist and fingers ROM will be measured 3 times, from enrollment to 48 hours after: T0 (first assessment), T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).]
• Semi-structured interview [Time frame: Results from the semi-structured interview will be collected 2 times, from enrollment to 48 hours after: T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).]