Retrospective Study on Safety of Acupuncture Treatments for Chronic Low Back Pain in 65 Years and Older in an Acupuncture Clinic From 2013 to 2018.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The rate of participates with bleeding
研究概览
简要总结
Acupuncture, along with other complementary and integrative treatments, is commonly used as a complementary or integrative therapy when treating a multitude of pain complaints, including chronic low back pain(CLBP). It has been practiced as a non-pharmacological therapy in the United States over one hundred years. Integrative pain management pilot programs have demonstrated impressive reductions in medications use, emergency room visits, and annual costs of healthcare. In fact, CLBP is one of the most common conditions treated in an acupuncturist's daily schedule. Based on acupuncturists' practice, CLBP has accounted for about 12% of patient visits in recent years. Most CLBP patients who come to acupuncturists' clinic are older adults. Investigators will retrospectively check the safety of acupuncture, i.e.side effects or adverse effects of acupuncture during treatments of CLBP in older adults in past 5 years.
详细描述
Back pain, especially low back pain (LBP), is one of the most common conditions for Americans to visit their physicians and therapists. In a recent survey, chronic neck and/or back pain was found to affect 54% of American adults in 2017. Another survey found that 32.5% of those 65 years and older suffer from back pain. Chronic low-back pain (CLBP) is defined by National Institutes of Health (NIH) as pain at the low back that persists for 12 weeks (3 months) or longer, even after an initial injury or underlying cause of acute low-back pain has been treated. About 20% of people affected by acute low-back pain develop CLBP with persistent symptoms at 1 year.
The inclusion criteria of CLBP in older adults:
Age: 65-80 years old. CLBP is defined as a back pain problem that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months. A minimum pain intensity score of 4 out of 10 on a visual analog scale (0 = no pain, 10 = most severe pain); ability of the participant to fully understand the trial procedure and the risks involved, communicate with the examiner, and comply with the protocol; provision of written informed consent for participation.
The exclusion criteria of CLBP in older adults:
Age: younger than 65. Pain mainly at legs; a history of spinal surgery; hip osteoarthritis; progressive neurological deficit or severe psychiatric or psychological disorders; serious spinal disorders, such as metastatic cancer, vertebral fracture, spinal infection, and inflammatory spondylitis; other contraindications for treatment, such as clotting disorders, use of anticoagulants or chemotherapy medications, and seizure disorders; presence of a device that could be affected by electromagnetic fields, such as a pacemaker; use of medications that could affect the trial results, such as corticosteroids and anticonvulsants, within the last week; participation in other clinical trials; ineligibility judged by a researcher.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 65-80 years old.
- •CLBP is defined as a back pain problem that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months.
- •A minimum pain intensity score of 4 out of 10 on a visual analog scale (0 = no pain, 10 = most severe pain);
- •ability of the participant to fully understand the trial procedure and the risks involved, communicate with the examiner, and comply with the protocol;
- •provision of written informed consent for participation.
排除标准
- •Age: younger than
- •Pain mainly at legs;
- •a history of spinal surgery;
- •hip osteoarthritis; progressive neurological deficit or severe psychiatric or psychological disorders;
- •serious spinal disorders, such as metastatic cancer, vertebral fracture, spinal infection, and inflammatory spondylitis;
- •other contraindications for treatment, such as clotting disorders, use of anticoagulants or chemotherapy medications, and seizure disorders;
- •presence of a device that could be affected by electromagnetic fields, such as a pacemaker;
- •use of medications that could affect the trial results, such as corticosteroids and anticonvulsants, within the last week;
- •participation in other clinical trials;
- •ineligibility judged by a researcher.
结局指标
主要结局
The rate of participates with bleeding
时间窗: 2013-2018
bruise in 3 levels: diameter\<5mm, 6-10mm, \>11mm
次要结局
- The rate of participates with fainting(2013-2018)
- The rate of participates with organ injury(2013-2018)
- The rate of participates caused Infection(2013-2018)
- The rate of participates with pain(2013-2018)