New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Volume
研究概览
简要总结
This study evaluates the effectiveness of an experimental proposal therapy for upper limb lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA consists in:
- Health education / patient empowerment.
- Neurodynamic activities oriented to Activities of Daily Living (ADL).
- Proprioceptive neuromuscular facilitation exercises oriented to ADL.
- Self-adherent self-adhesive antiedema of low compression.
Half of patients will receive TAPA treatment while the other half will receive CDT standard treatment.
详细描述
Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for breast cancer. Its incidence is approximately between 6 and 30% of patients and its prevalence varies between 15-20%. It is considered a process without spontaneous resolution that involves the application of a palliative therapy conservative for life, with preventive measures to reduce it and prevent complications and an expected increase in the number of patients with lymphedema in the next years
Changes in work performance resulting from lymphedema vary from minor temporary changes to significant difficulties in the ADL, depending on the chronicity and severity of the affectation. It could affect physical components and psychological, as well as social and economic environment. In these limitations on activities and / or restrictions of participation, the Occupational Therapists (OT) provide a unique approach, since they are professionals specifically enabled for the use of the therapeutic potential of the activity and graduation of its control parameters in favor of the best occupational performance possible of the person. Furthermore, there are some research that support the inclusion of OT in the cancer rehabilitation and reveal a significant need for more research to explore ways in which the OT favorably influences the results of the cancer survivors.
The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm the diagnosis of lymphedema, stage, possibilities of progression and approach the most indicated therapeutic in each case.
The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and compression garments.
The CDT comprises a series of measures, a first intensive phase consists of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In order to masking, investigator who assess the subject before and after the treatment will not know which group the subjects belong, and so the biostatistician.
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Upper limb lymphedema secondary to breast cancer grade I and II, according to the Working Group of the XI International Lymphology Congress
排除标准
- •Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the Working Group of the XI International Lymphology Congress
结局指标
主要结局
Volume
时间窗: Baseline and 5 weeks
Volume of the upper limb lymphedema using the Kuhnke formula (Vol=(C1\^2+C2\^2+...Cn\^2)/π). It allows you to assess the volume difference between the affected limb and the healthy one. According to the Working Group of the XI International Lymphology Congress, lymphedema are classified in grade I (mild) ( 10-25% difference), grade II (moderate) (26-50% difference) and grade III (severe) (\>51% difference).
Circometry
时间窗: Baseline and 5 weeks
Perimeter of upper limb lymphedema using a measuring tape in seven spots: Metacarpophalangeal, 5 and 10cm over radial styloid, 5cm under lateral epicondyle and 5, 10 and 15cm over lateral epicondyle. It is significative when there is a 2cm difference between the healthy and affected limb.
次要结局
- Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)(Baseline and 5 weeks)
- Upper Limb Lymphedema 27 (ULL-27)(Baseline and 5 weeks)
研究者
Antonio José Jiménez Vílchez
Physical Medicine & Rehabilitation Hospital Resident
Hospital Universitario Reina Sofia de Cordoba