Effect of Resistance Training of Persistent Pain After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in pain sensitivity, assessed through pressure pain thresholds.
研究概览
简要总结
Persistent pain after treatment for breast cancer is a major clinical problem, affecting 25-60 % of the patients and is a source of considerable physical disability and psychological distress. Thus, the development of novel interventions to improve pain management for these patients is of clinical importance. Resistance training (RT) is a promising tool to combat a variety of undesirable adverse effects due to breast cancer treatment. Further, research suggests that it may also be able to provide pain-relieving benefits.
Hypothesis: Resistance training will improve pain perception and physical function in the short- and long term compared to a non-training control group.
详细描述
Breast cancer is the most common cancer in women worldwide with more than a million new cases diagnosed every year [1]. Fortunately, due to better treatment options, the population of long-term survivors is increasing. This poses new demands for knowledge on how to manage late effects to the treatment regimen. Persistent pain after treatment for breast cancer is a common and underestimated problem as well as it can be a source of considerable physical disability and psychological distress [2]. Hence, the development of novel interventions to improve pain management is of high clinical relevance. Resistance training (RT) is a promising clinical therapeutic tool to improve a variety of adverse effects to breast cancer treatment [3] and may provide several pain-relieving benefits [4]. However, the efficacy of this modality for managing persistent pain after breast cancer treatment is currently unclear. Therefore, the purpose of this project is to investigate if individualized RT can modulate persistent pain after breast cancer treatment, thereby improving our understanding of how this modality may benefit patients and contribute to clinical guidelines for pain management in this clinical population.
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 (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor) The statistician, who will conduct the statistical analysis, will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of breast cancer (grades I-IIIA).
- •adult women at least 18 years of age.
- •having received breast cancer treatment (i.e. surgery and possible adjuvant chemo and/or radiotherapy) at least 18 months before the start of the study.
- •self reported pain in the areas of the breast, shoulder, axilla, arm and/or side of body with an intensity of ≥ 3 on a numeric rating scale (0 = no pain, 10 = worst pain imaginable).
- •no signs of cancer recurrence.
- •reading, writing and speaking Danish.
排除标准
- •breast surgery for cosmetic reasons or prophylactic mastectomy.
- •bilateral breast cancer.
- •lymphedema.
- •other chronic pain conditions (e.g., rheumatoid arthritis).
- •previous diagnosis of fibromyalgia syndrome.
结局指标
主要结局
Change in pain sensitivity, assessed through pressure pain thresholds.
时间窗: Baseline and at 3, and 6 months
Between group comparisons of treatment effect (change in pressure pain thresholds) from baseline to follow-up) will be performed. Pressure pain thresholds will be collected with a pressure algometer with a progressive increment in pressure of 30kPa.
Change in pain intensity, assessed through a 11 point numeric rating scale (0 = no pain, 10 = worst pain imaginable).
时间窗: Baseline and at 3, and 6 months
Pain intensity is collected in two different contexts; 1) recollection for the past 3 months and 2) movement evoked pain during testing and training.
次要结局
- Active shoulder range of motion assessed with a universal goniometer.(Baseline and at 3, and 6 months)
- Body composition assessed through bioelectrical impedance measurements.(Baseline and at 3, and 6 months)
- Arm circumference measured bilaterally at a single point 30cm above the styloid process.(Baseline and at 3, and 6 months)
- Physical activity level assessed through the international physical activity questionnaire (IPAQ).(Baseline and at 3, and 6 months)
- Health related quality of life assessed through the European Organisation for Research and Treatment of Cancer (EORCT)-C30 quality of life questionaire(Baseline and at 3, and 6 months)
- Muscular strength assesses through a 1 repetition maximum (1RM)(Baseline and at 3, and 6 months)
- Quality of life assessed through the breast cancer specific European Organisation for Research and Treatment of Cancer (EORCT)-BR23 quality of life questionaire(Baseline and at 3, and 6 months)
- Cancer fatigue assessed through the Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale.(Baseline and at 3, and 6 months)
- Mental health assessed through the Major Depression Index (MDI)(Baseline and at 3, and 6 months)
研究者
Gorm Henrik Fogh Rasmussen
Ph.D.-student
Aalborg University