Effectiveness of Short-stretch Bandages for Treatment of Hand Edema Compared to High Stretch Bandage: Cross Over Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Hand volume
研究概览
简要总结
The aim of this clinical trial is to compare the effectiveness of high and short stretch bandages in hand edema treatment of adult patients with affected hand volume superior of at least 5% compared to the contralateral hand. The main question to be answered by this study is: which bandage is more effective in reducing edema?
Endpoint 1: hand volume, measured by immersion volumetry (Valgrado method). Endpoint 2: ROM (range of motion) of the fingers and wrist, measured by goniometry.
Endpoint 3: Results of a semi-structured interview on participants subjective perception of hand function and esthetics, ADL performance and quality of life.
This study includes 2 groups (arms); each participantreceives both types of bandages but in a different temporal order depending on group membership:
- Arm A: short stretch bandage applied as the first treatment.
- Arm B: high stretch bandage applied as first treatment. Patients will be randomized 1:1 using the RedCap Software.
The entire study will take place over 3 consecutive days. On each of these days, participants are examined (hand volume, finger and wrist ROM), receive the bandage (the type of bandage depends on the participant group), undergo physiotherapy treatment and then practice specific hand mobilization exercises at home.
At the end of the study, the data on hand volume and mobility of the hand and wrist will be analyzed to determine which type of bandage, high-stretch or low-stretch one, is most effective in reducing hand volume (and therefore hand edema) and mobility of the hand and wrist.
In addition, data collected using the semi-structured interview will be analyzed to examine patients subjective perceptions of hand function and esthetics, ADL performance and quality of life.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Population A total of 45 patients will be recruited for this study, according to the following inclusion and
排除标准
- •Inclusion Criteria
- •Presence of hand edema, with the affected hand showing a volume at least 5% greater than the contralateral hand. Hand volume is measured using the Valgrado immersion volumetry method.
- •Edema of the following etiologies:
- •Traumatic (injury to the hand or upper limb resulting in edema of the hand or fingers)
- •Algodystrophic
- •Rheumatologic
- •Secondary to immobility
- •Exclusion Criteria
- •Lacerations or cut injuries to the forearm, due to the potential compromise of lymphatic drainage pathways from the hand.
- •Edema of etiologies other than those specified in the inclusion criteria. Specifically, edema due to infection or structural and/or functional impairment of the lymphatic system-of any nature, including iatrogenic-is excluded.
- •Pathologies involving the peripheral nervous system of the upper limb (e.g., nerve injuries with resulting paralysis).
- •Contraindications to active mobilization of the wrist and finger joints (metacarpophalangeal and interphalangeal joints).
结局指标
主要结局
Hand volume
时间窗: Hand volume 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).
Hand volume will be measured using immersion volumetry, according to the Valgrado method.
次要结局
- Range Of Motion (ROM)(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(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).)
研究者
Silvia Fontana
Medical Doctor, specialized in Physical Medicine and Rehabilitation, head of Hub Lymphedema Center AULSS 7 Pedemontana
Regione del Veneto - AULSS n. 7 Pedemontana