Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Low Back Pain in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Pain Score Difference
研究概览
简要总结
The effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) to reduce pain scores for patients with acute back pain in an ambulatory emergency department (ED) population will be examined in this dual-center, cluster randomized, controlled, open-label study.
详细描述
Back pain is one of the top 5 most common ED presenting complaints, accounting for approximately 3% of all ED visits. It is estimated that 85% of these patients will leave the ED with a non-specific diagnosis, such as mechanical low back pain, and will recover within 4-6 weeks. Unfortunately, treatment for these patients is limited and often consists of NSAIDs, acetaminophen, and opioids if in significant pain.
TENS is a non-pharmacological option for the treatment of pain. The mechanism of its effect is based on the gate control theory of pain; stimulation of large, myelinated fibers reduces transmission of pain through smaller, nociceptive C-fibers through inhibitory actions of interneurons. It is very safe, with very few reported adverse effects and a short list of contraindications.
In 2015, a Cochrane review examined the benefit of TENS in acute pain, which was defined as less than 12 weeks. Their review demonstrated tentative evidence of benefit in reducing pain, although due to the small sample sizes of the encompassing trials and the inability to blind, definitive conclusions are impossible.
Research question: "In patients in the ED triage area,18 years of age or older with acute or acute-on-chronic back pain for less than three weeks, does 30 min of transcutaneous electrical nerve stimulation reduce pain scores as compared to standard care alone?"
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older.
- •Acute or acute-on-chronic back pain, defined as less than 3 weeks of increased symptoms.
- •Canadian Triage and Acuity Scale (CTAS) level 3-5 in ambulatory section of emergency department
- •Projected wait-time of at least 30 minutes.
- •Comfortable with communication in English. Unfortunately, currently, we do not have the capacity or funding to hire a translator to translate our study documents or communicate with potential study participants.
排除标准
- •Back pain "red flags" on initial history. These include:
- •Patient reported fever.
- •Recent direct blunt or penetrating trauma to the back, perceived by the patient to be the cause of acute pain or exacerbation of chronic pain.
- •Bilateral radicular symptoms.
- •Changes in ability to empty bladder or urinary incontinence since onset of back pain.
- •Incontinence of stool.
- •Saddle anesthesia.
- •Intravenous drug use within the last 30 days.
- •History of spinal cord injury.
- •Epilepsy.
- •Abnormal triage vital signs:
- •Temperature greater than 38 C
- •Abnormal blood pressure (BP) defined as systolic BP less than 90 or over
- •Tachypnea with respiratory rate (RR) greater than
- •Active pregnancy (patient warning on product label)
- •Canadian Triage and Acuity Scale (CTAS) level 1-
- •Implanted pacemaker or neurostimulation device.
- •TENS unit in use by another patient at time of screening
- •Wound, abrasion, rash over where TENS pads will be placed.
结局指标
主要结局
Pain Score Difference
时间窗: Change from baseline score at 60 minutes of study participation.
Pain score as a primary outcome will be assessed by determining the difference in VAS between T0 and T60. VAS is a validated tool for measuring subject reports of pain in a variety of patient care settings. T60 was chosen as the primary endpoint as this was thought to allow sufficient time for standard care (ie. pharmacotherapy) to take effect. A clinically significant reduction of pain was defined as 30% on VAS, based on prior literature.
次要结局
- Opioid requirements(After 60 minutes of study participation.)
- ED Return Visits(Within 2 weeks of study participation.)
- Pain score at T30(After 30 minutes of study participation.)
研究者
Sam Brophy
Principal Investigator
Vancouver Island Health Authority