Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pain severity on 11-point Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED.
详细描述
The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED.
This pilot study will use a randomized controlled trial design to compare the effects of ISWI to intracutaneous dry injections in patients presenting to the ED with acute low back pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Active Duty and DoD Beneficiaries aged 18 to 64 years.
- •Presenting to the ED with a chief complaint of acute low back pain of less than 2 weeks in duration.
- •Pain severity on presentation of greater than or equal to 5/10 on Visual Analogue Scale.
排除标准
- •Traumatic low back pain
- •New weakness or neurologic deficit
- •New loss bowel/bladder control
- •Back pain above T12
- •Active cancer
- •Currently taking anticoagulant medications
- •Signs of infection or trauma over the injection site
- •Non-English speaking
- •Pregnancy
结局指标
主要结局
Pain severity on 11-point Visual Analogue Scale (VAS)
时间窗: 30 minutes post treatment
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case the scale is accompanied by the Wong-Baker faces pain rating scale. Min pain score is 0, max pain score is 10. Lower scores mean a better outcome and higher scores mean greater pain severity.
次要结局
- Satisfaction score on 11-point Visual Analogue Scale (VAS)(30 minutes post treatment)
研究者
Lindsey schmelzer
Principal Investigator
Mike O'Callaghan Military Hospital