Traditional Chinese Herbal Compound as Complementary Treatment for Non-specific Low Back Pain: A Randomized Controlled Trail Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Patients with low back pain who were seen between January 1, 2022 and June 16, 2023 were included;
- •b. meet the diagnostic criteria of NSLBP;
- •c. the age range was 20-90 years old;
- •d. agree to participate in the study and sign the informed consent;
排除标准
- •a. those who are unable to communicate normally, such as those suffering from mental and cognitive diseases, and cannot cooperate with the treatment;
- •b. pregnant or lactating women;
- •c. patients who are allergic to the treatment components or sulfonamides;
- •d. patients with a history of coronary artery bypass grafting;
- •e. patients with active gastrointestinal ulcer or bleeding;
- •f. patients with severe heart failure;
- •g. Patients with hepatic and renal insufficiency.
研究组 & 干预措施
herbal compound
干预措施: herbal compound (Drug)
celecoxib
干预措施: Celecoxib (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: baseline, 1 week, 2 week, 3 week after treating
The visual analogue scale (VAS) is used to assess pain. It is widely used in clinical practice worldwild. The basic method is to use a walking scale about 10cm long, marked with 10 scales on one side, and the two ends are respectively "0" and "10". 0 indicates no pain, and 10 indicates the most unbearable pain. A higher score means more intense pain.
Oswestry disability index
时间窗: baseline, 1 week, 2 week, 3 week after treating
The Oswestry Disability Index (ODI) consists of 10 questions about pain intensity, self-care, lifting, walking, sitting, standing, disturbance of sleep, sexual life, social life, and travel, with six options for each question. The maximum score for each question is 5. Select the first option to score 0 points, select the last option to score 5 points, if there are 10 questions have been answered, the scoring method is: actual score /50 (highest possible score) × 100%, if there is a question not answered, the scoring method is: Actual score /45 (highest possible score) x 100%, if higher indicates more severe dysfunction.
Japanese Orthopaedic Association Scores
时间窗: baseline, 1 week, 2 week, 3 week after treating
Japanese Orthopaedic Association Scores are evaluated from four aspects: conscious symptoms, objective examination, limit of daily activities and bladder function. Each part is composed of several questions, with 3-4 options for each question. The highest score for each question is 2 or 3 points. The overall score ranges from 0 to 29, with lower scores indicating greater dysfunction.
次要结局
未报告次要终点
研究者
Yangjun Lao
Zhejiang Traditional Chinese Medicine Science and Technology Plan Project Leader
Zhejiang Provincial Tongde Hospital