A Prospective Cohort Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Pain in the Musculoskeletal System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,029
- 试验地点
- 1
- 主要终点
- Global Pain Assessment Scale score
研究概览
简要总结
A prospective cohort study on the treatment of chronic pain in the musculoskeletal system with Compound Nanxing Pain Relief Ointment. This study adopted an observational research design. Through a cohort study, patient medical records were collected to meet the criteria of chronic pain classification in International Classification of Diseases 11th Revision (ICD-11), which is located in the musculoskeletal system and occurs in the neck and shoulders, waist and back, limbs, and meets the diagnostic criteria of "cold syndrome" in traditional Chinese medicine. The target population was selected to evaluate the clinical effects of Compound Nanxing Pain Relief Ointment in treating chronic pain in the musculoskeletal system, reducing pain, improving muscle and bone function status, and enhancing quality of life. The study aimed to compare the heterogeneity of the clinical effects of Compound Nanxing Pain Relief Ointment in treating chronic pain in the musculoskeletal system. The study plan included 3000 patients, and no intervention in treatment and medication was provided to the patients during the observation period. The shortest medication duration was 2 weeks, and the longest observation period was 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For those who visit the orthopedics department, rheumatology department, or pain clinic:
- •Those whose pain is located in the musculoskeletal system as classified in International Classification of Diseases 11th Revision(ICD-11) for chronic pain, and occurs in the neck, shoulders, waist, back, or limbs;
- •Those who meet the diagnostic criteria of "cold syndrome" in traditional Chinese medicine, and their chronic pain worsens or occurs when exposed to cold;
- •Those with continuous or intermittent pain lasting more than 3 months, and without surgical indications.
排除标准
- 未提供
研究组 & 干预措施
exposed group
Use Compound Nanying zhitong Ointment alone, or use it in conjunction with conventional Western medicine treatment, without using any other similar Chinese patent medicines or traditional Chinese medicines.
干预措施: Compound Nanying zhitong Ointment (Drug)
The non-exposure group
Do not use any other similar proprietary medicines or traditional Chinese medicines.
干预措施: Do not use any other similar proprietary medicines or traditional Chinese medicines. (Other)
结局指标
主要结局
Global Pain Assessment Scale score
时间窗: The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.
There are a total of 20 items, each rated on a scale of 0 to 10. The total score is calculated by adding up the scores of all items and then dividing by 2. The score range is from 0 to 100. The higher the score, the more severe the pain and its impact.
次要结局
- Pain relief time(The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.)
- Time when pain disappears(The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.)
- Number of days without pain episodes(The scores of the Global Pain Assessment Scale were evaluated on Day1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.)
- Score of TCM syndromes/signs(The TCM syndrome scores were evaluated on Day 1, as well as at the 2nd, 4th, 8th, and 12th weeks after the treatment.)
- Score of the Short Form 12 Health Survey (SF-12)(The Short Form 12 Health Survey (SF-12) test was evaluated on day1, as well as at the 2nd, 4th, 8th and 12th weeks after the start of treatment.)