Observational Study on Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain Due to the Shoulder Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale of shoulder pain
研究概览
简要总结
This study is a prospective, case-control observational trial. The investigators will compare the Megadose Shinbaro Pharmacopuncture group to the control group to analyze the effectiveness of shoulder Megadose Shinbaro Pharmacopuncture.
详细描述
Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.
Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases.
This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.
Therefore, The investigators conducted observational trial to analyze the effectiveness of Megadose Shinbaro Pharmacopuncture on shoulder. From Dec 2019, The investigators will collect 80 patients with Chronic shoulder pain on both or each shoulder with the numeric rating scale(NRS) over 4.
The investigators will compare pain, dysfunction, quality of life and satisfaction of patients who are treated with Korean medical treatment including Megadose Shinbaro Pharmacopuncture and patients who are treated with Korean medical treatment not including Megadose Shinbaro Pharmacopuncture.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NRS ≥ 4 for shoulder pain over 3weeks
- •Patients aged 19-70 years on the date they sign the consent form.
- •Patients who provide consent to participate in the trial and return the informed consent form
排除标准
- •Patients who have been diagnosed with a severe disease that may cause shoulder pain,
- •Patients with progressive neurological deficit or with serious neurological symptoms caused by spinal cord compression.
- •Patients who visited a hospital in pain caused by a traffic accident.
- •Patients with a severe mental illness.
- •Patients who are difficult to complete the research participation agreement
结局指标
主要结局
Numeric Rating Scale of shoulder pain
时间窗: At 2 weeks
The extent of shoulder pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their shoulder pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- EuroQol 5-Dimension(At baseline, 2 weeks, 3 months)
- Numeric Rating Scale of shoulder pain(At screening, baseline, 3 months and through study completion, an average of 3 month)
- Visual Analogue Scale of shoulder pain(At screening, baseline, 2 weeks and through study completion, an average of 3 month)
- Patient Global Impression of Change(At baseline, 2 weeks, 3 months)
- Number of Participants with Adverse events(Through study completion, an average of 3 month)
- Shoulder mobility on the Shoulder ROM(At baseline, 2 weeks and through study completion, an average of 3 month)
- Shoulder Pain and Disability Index questionnaire of shoulder pain and disability(At baseline, 2 weeks, 3 months)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation