Effectiveness of Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men: A Randomized Controlled Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- 1. International Prostate Symptom Score (IPSS - Hong Kong Chinese Version 2)
研究概览
简要总结
Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively affects the quality of life (QoL) of majority of the male aging population. Although LUTS are not life threatening, these symptoms include urinary retention, voiding difficulty, frequent feeling of urinary urgency, and nocturia, all of which negatively affect the daily functions, sleep quality, and sexual activities of patients. Despite the proven effectiveness of conventional pharmacological therapies, most men are reluctant to try these treatments because of perceived side effects and potential complications. Other non-invasive complementary treatments for LUTS should be explored because of the limitations of pharmacological therapy.
Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a therapeutic method in which specific points in the auricle are stimulated to treat various physical disorders. AT is a specialized form of acupuncture in which the ear is viewed as a microsystem of the body. A minimally invasive measure of AT, instead of using needles, is adopted in this study to avoid pain induction.
This randomized controlled trial (RCT) aims to determine the effectiveness of AT in improving the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL, and improving sleep conditions. Male subjects, who are 60 years old or above and with moderate to severe LUTS, will be recruited.
Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points on one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will receive LA and placebo MAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to affect LUTS will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study can advance our knowledge of complementary approaches to improve the LUTS conditions of the elderly population and the feasibility of AT among clients with LUTS in a future large-scale study.
详细描述
Research hypotheses:
- Magneto-auriculotherapy (MAT) or laser auriculotherapy (LA) alone or use in combination are more effective than the control treatment in terms of symptom relief in male elderly patients suffering from LUTS.
- MAT or LA alone or use in combination are more effective than the control treatment in terms of enhancement of QoL, and improvement of sleep conditions in male elderly patients suffering from LUTS.
Primary objective To investigate whether MAT or in combination with LAT are more effective than the control treatment in terms of symptom relief in male elderly patients suffering from LUTS.
Secondary objectives
- To determine whether MAT or in combination with LAT are more effective than the control treatment in terms of enhancement of QoL, and improvement of sleep conditions in male elderly patients suffering from LUTS;
- To assess the feasibility of using AT among LUTS patients in a future large-scale study, including the use of blinding, acceptance of treatment protocol, follow-up for repetitive testing, estimating effect size and attrition rate.
- To compare the treatment effect and the feasibility of this study to be conducted in Hong Kong and China Mainland.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment arm 1
Subjects will receive MAT and placebo LA. The magnetic pellets will be applied to the six selected acupoints as detected by an acupoint finder. To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. Subjects will be asked to wear a pair of laser protective goggles to "blind" them during treatment.
干预措施: MAT & LAT (Other)
Treatment arm 2
Subjects will receive a combined approach that includes the use of MAT and LA. A laser device (Pointer Pulse™) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz, which is a common acceptable dosage for clinical use (King et al., 1990; Round et al., 2013). This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear. Laser protective goggles will be provided to the subjects and the researchers for eye protection.
干预措施: MAT & LAT (Other)
Treatment arm 3
Subjects will serve as a placebo control and will receive LA at "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of plasters centred with a small portion of Junci Medulla (mimicking the MAT treatment).
干预措施: MAT & LAT (Other)
结局指标
主要结局
1. International Prostate Symptom Score (IPSS - Hong Kong Chinese Version 2)
时间窗: collected at baseline up to 3 months after therapy
This instrument will be used to collect information regarding the LUTS condition of the subjects. The instrument consists of seven Likert-scale questions \[scores from 0 (not at all) to 5 (almost always)\] that will address two aspects of LUTS. Three questions involve filling problems (daytime frequency and nocturnal urgency), and four questions assess voiding problems (emptying, intermittency, weak stream, and straining). The total IPSS score from the seven questions ranges from 0 to 35. The IPSS (Hong Kong Chinese version 2) has been recently validated and found to be a valid, reliable, and sensitive measure for assessing Chinese populations with LUTS (Cronbach's alpha coefficient = 0.71, ICC of the symptom questions = 0.80, ICC of the QoL = 0.70) (Choi et al., 2014). This tool will be set as the primary variable to indicate the actual effect size and continuously monitor the effectiveness of the treatments throughout the study.
次要结局
- 2. Post-void residual urine test(collected at baseline up to 3 months after therapy)
- Patient satisfaction towards therapy(collected at baseline up to 3 months after therapy)
- Other parameters(collected at baseline)
- Subjects' expectations towards therapy(collected at baseline up to 3 months after therapy)
- Maximum urinary flow rate (Qmax)(collected at baseline up to 3 months after therapy)
- Pittsburgh sleep quality index(collected at baseline up to 3 months after therapy)
研究者
Lorna Suen
Associate Professor
The Hong Kong Polytechnic University