Effects of Physical Exercise and Motor Activity on Post-mastectomy Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
研究概览
简要总结
Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain.
Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.
详细描述
Acute post surgery pain is defined as a normal physiological response to an injurious stimulus.
Adequate monitoring associated with appropriate postoperative pain therapy significantly contribute to the improvement of perioperative morbidity, assessed in terms of lower incidence of postoperative complications. In addition, many patients undergo important changes in emotional and affective behavior: acute pain anxiety is often replaced by reactive depression and hypochondria combined with somatization and worsening of quality of life. The latter is an important factor in the context of tumor pathology. Since, while the goal of achieving 100% survival in women with breast cancer is still pursued, so too is improving the quality of life and restoring optimal levels of function of patients.The benefits of physical activity on the general population have been extensively studied. It has been shown that physical activity in the cancer patient allows the recovery of the previous functional capacities, strength and flexibility, improvement of the pain symptom and asthenia, as well as the reduction of alterations in the haematological picture such as neutropenia, anemia, thrombocytopenia.
Breast cancer is due to the uncontrolled multiplication of certain cells in the mammary gland which turn into malignant cells. The most frequent tumors arise from glandular cells (lobules) or from those that form the wall of the ducts.
Breast cancers can be invasive or non-invasive. The most invasive forms are usually ductal carcinoma, which affects the milk ducts beyond the duct wall and accounts for 70-80 percent of all forms of breast cancer, and lobular carcinoma that exceeds the wall of the lobule. Breast cancer is classified into 5 stages (0 to IV).
Chronic post mastectomy pain is a condition characterized by pain in the front of the chest, armpit, and / or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery (International Association for the Study of Pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over the age of 18 with a diagnosis of previous Stages I-III breast cancer.
排除标准
- •medical history of other types of cancer;
- •disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
- •recent symptoms of illness (cough, fever);
- •waiting breast reconstruction;
- •not chemotherapy or radiation during the first six months after surgery:
结局指标
主要结局
Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
时间窗: Evaluation performed three and six months after surgery
Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10).
Effects of motor and/or sports activity on interference of chronic pain in women underwent mastectomy.
时间窗: Evaluation performed three and six months after surgery
Interference of pain in activities of daily living is a key biomarker for establishing adequate pain therapy. Interference of pain measured with the Brief Pain Inventory - Short Form. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily activities. Each item is scored on a 10 point numeric rating scale where 0 = no interference/pain and 10 = severe or complete interference/pain.
次要结局
- Biomarkers of inflammation.(Evaluation performed three and six months after surgery)
- Biomarkers of oxidative stress(Evaluation performed three and six months after surgery)