NCT02988232已完成4 期
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from Baseline in Numeric Rating Scale of Pain
研究概览
简要总结
The Purpose of this trial is to investigate the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
详细描述
Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
- •Age 19 - 65
- •Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)
- •Patients must include all of the following symptoms:
- •Those who have 4 ~7 cm of VAS pain score;
- •Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire
- •Ability to have normal communication
- •Ability to give informed consent
排除标准
- •Patients with pain duration of 3 months or less
- •Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
- •Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
- •Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
- •Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- •Patients with history of spinal surgery
- •Patients with more severe pain than pain caused by low back pain
- •Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
- •Patients with history of Medical Malpractice Case
- •Patients with treatment history of low back pain within 1 month either KM or WM
- •Patients participating in other clinical studies within 3 months
- •Pregnant patients or patients with plans of pregnancy or lactating patients
- •Patients disagree to sign the informed consent form
- •Patients deemed unsuitable for participating the trial by the researchers
研究组 & 干预措施
Treatment(SGHH)
Experimental
Admission to Sogyeonghwalhyeol-tang granule
干预措施: Sogyeonghwalhyeol-tang (Drug)
Placebo
Placebo Comparator
admission to placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Numeric Rating Scale of Pain
时间窗: Screening Visit, At baseline, week 2, 4, 6, 8
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.
次要结局
- Change from Baseline in European Quality of life 5 Dimension(Screening Visit, At baseline, week 2, 4, 6, 8)
- Change from Baseline in 'Roland Morris Disability Questionnaire'(Screening Visit, At baseline, week 2, 4, 6, 8)
研究者
Yun-Kyung Song
KMD PhD
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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