Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- VAS: Visual Analogic Scale of pain
研究概览
简要总结
The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.
详细描述
Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.
The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aged 18 and over
- •Patients diagnosed with back pain: cervical, thoracic or lumbar.
- •Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist
- •Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist
- •Patients with sufficient cultural and educational level to complete the health questionnaires required in the study
- •Patients who have given their written informed consent to participate in the study
排除标准
- •Patient with any illness and that medical opinions recommended not to participate in the study
- •Patient can not respond to questionnaires administered during the study
结局指标
主要结局
VAS: Visual Analogic Scale of pain
时间窗: 10 weekly visits
Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS). This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study
次要结局
- Sheehan Disability Questionnaire(First Visit (week 1) and Final Visit (week 10))
- Evaluation of the Scale Hospital Anxiety Depression (HAD)(First Visit (week 1) and Final Visit (week 10))
- Health Questionnaire EuroQol-5D(First Visit (week 1) and Final Visit (week 10))
- Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)(First Visit (week 1) and Final Visit (week 10))
- McGill Pain Questionnaire(10 weekly visits)