Effectiveness of Auricular Acupressure for Chronic Low Back Pain and Related Symptoms in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The Chinese Roland-Morris Disability Questionnaire
研究概览
简要总结
Participants were recruited from two areas in southern Taiwan: the traditional Chinese medicine outpatient clinics at Kaohsiung Medical University Chung-Ho Memorial Hospital and Kaohsiung Municipal Siaogang Hospital, as well as community-based traditional Chinese medicine clinics. Individuals interested in participating were interviewed in the research office on the same day. The inclusion criteria were: (1) women aged 50-65 years and (2) low back pain lasting longer than 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 50-65 years
- •Chronic low back pain lasting longer than 12 weeks
排除标准
- •Unable to read
- •Cardiovascular conditions, including cardiac arrhythmia, heart failure, or coronary artery disease
- •Malignant tumor
- •Infection or open skin lesion on or around the ear
- •Previous lumbar spine surgery
研究组 & 干预措施
Auricular Acupressure
干预措施: auricular acupressure (Device)
sham auricular acupressure
干预措施: sham auricular acupressure (Device)
结局指标
主要结局
The Chinese Roland-Morris Disability Questionnaire
时间窗: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
The questionnaire consists of 24 self-reported items assessing the impact of low back pain on daily functioning. Each item is answered as either "Yes" or "No," with "Yes" scored as 1 and "No" scored as 0. Higher total scores indicate greater functional disability.
Brief Pain Invetory- Taiwan Form, BQT, BPI-T
时间窗: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
The scale consists of two sections with a total of 11 items. The first section, pain severity, consists of four items that assess the severity of pain in individuals with low back pain. The second section, pain interference, consists of seven items that assess the extent to which pain interferes with daily functioning. Each item is rated on an 11-point numeric rating scale ranging from 0 to 10, with 0 indicating no impact and 10 indicating extreme impact. Scores of 1-4 indicate mild severity, scores of 5-6 indicate moderate severity, and scores of 7 or higher indicate severe severity. Higher scores indicate greater pain severity or greater interference with daily functioning.
次要结局
- the Greene Climacteric Scale(Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).)
研究者
Chia Fen Wu
Principal Investigator
Kaohsiung Medical University