Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women: Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Medical questionnaire
研究概览
简要总结
Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.
Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be of legal age
- •Having suffered from primary breast cancer with histological confirmation (I-IIIA)
- •Completion of primary carcinoma treatment (surgery, chemotherapy, radiotherapy)
- •To be receiving hormone therapy as an adjunct to the process by aromatase inhibitors (exemestane, anastrozole, letrozole)
- •To present a functional status according to WHO from 0 (asymptomatic, complete and ambulatory activity) or 1 (symptomatic but completely ambulatory, strenuous physical activity restricted but able to perform sedentary gentle activities)
- •To understand correctly Spanish
- •To show their approval by signing the informed consent
- •Having had musculoskeletal disorders attributable to IA.
排除标准
- 未提供
研究组 & 干预措施
Neuromuscular taping
The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).
干预措施: Neuromuscular taping (Drug)
结局指标
主要结局
Medical questionnaire
时间窗: 10 minutes
A record will be kept of some medical data such as tumor grade, types carried, complementary treatments and end date, and the type of hormone therapy received and start date. The possible presence of comorbidities will also be collected. Genetic determinants. Analyze genetic determinants due to the importance of genetic background on AIA and abandonment of therapy (Garcia-Giralt N., 2013). Estrogen receptor 1 (ESR1), aromatase (CYP19A1) and steroid, 17-alpha-hydroxylase / 17,20 lyase (CYP17A1) (Garcia-Giralt N., 2013), (Henry NL, 2012) and (Mao JJ, 2011) have been selected as candidate genes. Samples for extracting genes will be collected in both cases with controls on the baseline and the end of it. The DNA is extracted from whole blood using the DNA Blood Maxi Qiafilter (Qiagen, Inc., Valencia, CA) (Henry NL, 2013) kit.
次要结局
- Sociodemographic and anthropometric questionnaire(10 minutes)
- Plasma proteins (or proteomic analysis)(10 minutes)
- PPT(10 minutes)
- Grip strength as measured by a Dynamometer(5 minutes)
- POMS(10 minutes)
- quality of life as assessed by QuickPIPER questionnaire(10 minutes)
- EORTC QLQ-C30(10 minutes)
- pain as measured by VAS(10 minutes)
- SFI-Sp(10 minutes)
- ULFI-Sp(10 minutes)
- BADIX(10 minutes)
研究者
Dr. Antonio I Cuesta-Vargas
Professor of Faculty of Health Sciences
University of Malaga