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临床试验/NCT03715413
NCT03715413已完成2 期

Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

Mansoura University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
64
试验地点
1
主要终点
VAS

研究概览

简要总结

Background: Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast disease. Mastalgia may be bilateral, may be in only one breast or part of one breast, and may radiate to the axilla and down the medial aspect of the upper arm. This study aimed to evaluate the additional pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia to the routine regimen treatment of mastalgia tamoxifen 10 mg daily may improve breast pain severity and quality of life.

Method: Patients was randomly classified into two groups:Group A (n=13): they was received Tamoxifen 10 mg daily. Group B (n=13): they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. The following parameters were monitored: Primary outcome: VAS after injection and at interval two weeks, 1, 2 and 3 months after injection. Secondary outcome:1-Immediate complications for ex. Hematoma, neurological deficits or respiratory insufficiency (dyspnea or pneumothorax).2-Need for analgesic intake was recorded.3-Side effect of Tamoxifen as nausea, vomiting, hot flashes and dizziness.4-Quality of life (The American Chronic Pain Association's Quality of life scale).

详细描述

Introduction:

Breast pain, mastalgia or mastodynia, is recognized as an organic benign breast disease . It can be severe enough to cause disturbances in normal quality of life rating which leads to disorders in sexual, physical, and social activities. When compared with other conditions, it will be similar to chronic cancer pain in the mean pain-index .

Breast pain is classified into three main categories: cyclical, non-cyclical and extra-mammary mastalgia. Cyclical pain is the commonest and it has a temporal association with the menstrual cycle. Pain characteristically starts in the days before menstruation and gradually increases. It tends to subside once menstruation has started and often disappears after a few days. Pain in these women usually abates after the menopause. These factors suggest a hormonal aetiology, high level of estrogen, low level of progesterone, and imbalance in estrogen to progesterone ratio are assumed among its causes, as well. Furthermore, many women associate the onset and resolution of cyclical mastalgia with a hormonal event, such as pregnancy or taking the oral contraceptive pill .

In contrast, there is no relationship to the menstrual cycle with non-cyclical mastalgia. Non-cyclic breast pain may result from pregnancy, mastitis, trauma, thrombophlebitis, macrocysts, psychologic disturbance, benign tumors, or cancer. However, only a minority of breast pain is explained by these conditions. Most non-cyclic breast pain arises for unknown reasons. Typically, it presents at a later age; most women are in the fourth or fifth decade of life at diagnosis. Many women are postmenopausal at onset of symptoms. Unfortunately, the course of both cyclical and non-cyclical mastalgia may be long and last many years.

The origin of extra-mammary pain is variable. Referred pain from cardiac, pulmonary and gastrointestinal causes, such as angina, pneumonia and oesophagitis, respectively, need to be excluded. A common cause of extra-mammary mastalgia arises from inflammation of the costochondral junctions of the chest wall (Tietze's disease). This condition usually resolves with rest and non-steroidal anti-inflammatory drugs .

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • complain from non-cyclic mastalgia aged from 20 to 60 with VAS > 4

排除标准

  • cyclical mastalgia
  • extra-mammary mastalgia
  • patients refusal
  • suspicion of malignancy
  • acute inflammatory breast conditions
  • presence of polycystic ovarian diseases or cervical hyperplasia
  • pregnant patients and patients during lactation period
  • coagulopathy disorder
  • sepsis at the side of injection
  • history of thromboembolic disease
  • mental disorder and who was not willing or cannot finish the whole study
  • disturbed anatomy (congenital, traumatic, and postsurgical), which increase the intervention difficulty.

研究组 & 干预措施

Tamoxifen group

Other

they was received Tamoxifen 10 mg daily.

干预措施: Tamoxifen (Drug)

Tamoxifen and pulsed radiofrequency group

Active Comparator

they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.

干预措施: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia. (Other)

Tamoxifen and pulsed radiofrequency group

Active Comparator

they was received Tamoxifen 10 mg daily and pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.

干预措施: Tamoxifen (Drug)

结局指标

主要结局

VAS

时间窗: 3 months

0=no pain, 10=worst pain

次要结局

  • Immediate complications for ex(one day)
  • Side effect of Tamoxifen(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nevert Adel

lecturer of anesthesia

Mansoura University

研究点 (1)

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