Efficacy of an Integrative Approach Utilizing Acupuncture as an add-on Therapy for the Treatment of Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
研究概览
简要总结
This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting
Acupuncture is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective therapy for simple back and neck pain in an ER setting.
This study will examine weather Acupuncture can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Acupuncture will be performed as an add on therapy on top of analgesic therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
- •Agreed to a physical examination and by an orthopedic physician and X-ray
- •Diagnosis of simple back pain with levels of 4<NRS at least
- •Agreed and able to fill pain, anxiety and satisfactory questioners
- •Agreed and able to sign informed consent
排除标准
- •Fracture, sprain or neurological deficit during physical examination
- •Pain scale of NRS< 4
- •Referred or radiating pain
- •Active pregnancy
- •Active inflammatory arthritis
- •History of CVA
- •Open wounds
- •Acute malignancy with life expectancy of less than 5 years
- •Experience with acupuncture treatments
- •History of drug addiction
- •History of osteoporosis
- •Declined or unable to sign informed consent
- •Soldiers in active military service
结局指标
主要结局
A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
时间窗: At day of treatment, after 24 hrs
次要结局
- 4.2.1 A comparable difference in range of motion between a combined medication and acupuncture treatment to medication treatment alone as measured by Spine Scan Device and physical exam using gonoimeter(day of treatment, after 24 hrs)
- 4.2.2 A comparable difference in patient self reported anxiety assessed by Hebrew version of the anxiety and somatization sections of the Symptom Check List-90 questioner (SCL-90)(day of treatment)
- 4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment(day of treatment and after 24 hours)
- 4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires(day of treatment, after 1 weekl)
研究者
Assaf Harofeh MC
Head of Emergency Department
Assaf-Harofeh Medical Center