Aromatherapy for Management of Back Pain in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute Pain Reduction
研究概览
简要总结
Pain control for acute isolated back pain and sciatica is a nebulous and often illusive task in the emergency department, and a challenge face everyday by emergency medicine physicians. Standard pain control practices are poorly defined in practice and in the literature. NSAIDs alone have been shown to be less-than-adequate controllers of acute back pain warranting emergency department visits and have little bearing on long-term pain control or recovery. Opioids are additionally poor long-term pain controllers and are gaining public controversy for their overuse. Modalities such as acupuncture, massage, thermotherapy, and spinal manipulation have been described in the literature with minimal evidence. Aromatherapy for pain control has been recently demonstrated as effective in the management of burn-dressing changes as well as post-operative pain management in children. It is an inexpensive and easily employed modality not yet explored in the emergency department for acute pain such as isolated back pain and sciatica. The authors propose to study Rosa damascena oil aromatherapy for the control of isolated acute back pain in the emergency department compared to almond oil placebo. The authors hypothesize that Rosa damascena will provide additional pain relief, as a known analgesic, when compared to almond oil aromatherapy. The authors will identify patients presenting to the Stony Brook University Hospital (SBUH) Emergency Department (ED) with acute isolated back pain and sciatica and test this hypothesis using a blind randomized approach. Patients included will be those above the age of 18 with isolated, non-traumatic back pain and sciatica lasting less than 2 weeks. Primary outcomes measured will include decrease in pain severity on a visual analog scale after 30 minutes of aromatherapy and again at 60 minutes post-therapy. Secondary outcomes measured will include patient satisfaction, need for clinician-determined rescue medications, and minimal clinical importance difference of pain control. Aromatherapy will be provided with both essential oil concentrated Rosa damascena and almond extract delivered via soaked-cotton ball 20-30 cm from the patient's face.
详细描述
A. SPECIFIC AIMS This study aims to research the use of aromatherapy for pain control in the emergency department, specifically, acute back pain. Aromatherapy, particularly Rose Essential Oil (Rosa damascena) has been studied in recent literature and shown to be effective versus placebos for the control of acute pain with lasting effects during burn dressing changes and post-operative pain management. These studies have been small and specific to discrete clinical conditions. Their evidence supports the use of aromatherapy for acute pain control with additional patient satisfaction benefit, but they are not yet externally validated to more common conditions facing emergency medicine physicians. The investigators chose to study acute isolated back pain and sciatica presenting to the emergency department and the use of Rosa damascena essential oil versus a control of Almond Oil for the treatment of isolated back pain and sciatica. The authors will investigate the use of aromatherapy in pain management by measuring and comparing pre- and post-treatment pain levels using a 100 mm visual analog scale (VAS) for pain. A significant reduction in pain by 13 mm on the VAS has been previously demonstrated as the minimal clinically important difference for treatment of pain. The primary endpoint will be the evaluation of significant change in VAS score greater than 13 mm between both groups immediately following a 30 minute blinded aromatherapy treatment and again 30 minutes later. The secondary endpoints include patient satisfaction, need to rescue medication (its type and dose), and subjective changes in pain.
B. Background and Significance Aromatherapy has been hypothesized to be an effective management strategy for acute pain control. Its use has been recently demonstrated in Iran, using Rosa damascena (Damask Rose) essential oil. Rosa damascena is believed to possess anti-anxiolytic, sedative, anticonvulsive, and analgesic effect on the central nervous system (CNS) when delivered through the olfactory system (Mohebitabar et al. 2016). This theory is believed to be in part due to the lateral gate theory of pain control and a stimulant's ability to inhibit transmission of stimuli through pain fibers. However, while any olfactory stimulant might be hypothesized to do just that, only Rosa damascena has been shown to produce significant reduction in pain on the VAS as well as patient satisfaction when compared to scented placebos like Almond Oil. Rosa damascena has been shown to improve pain control during dressing changes of second- and third-degree burns (Bikmoradi et al 2016). It has also been shown effective and equal to NSAID treatment of immediate post-operative pain in children (Marofi et al. 2015). It may be an affordable and easy-to-use modality for pain control in the emergency department. Its prior studies are small in sample size and carry little external validity that could be applied to an American Emergency Department population. The authors aim to assess whether aromatherapy using Rosa Damascena is reproducible in the emergency department for control of isolated and acute back pain, two common painful conditions seen with poor evidence for proper pain control. Validity of Rosa damascena aromatherapy in acute back pain and sciatica may open new doors of pain control to be researched in the emergency department and will further characterize the use of aromatherapy in modern medicine.
C. Preliminary Studies The known external studies of Rosa damascena have been cited above and will be presented in the references section. The authors have not yet studied aromatherapy in the emergency department and will be completing this study fresh, based on methodology used in external aromatherapy and back pain treatment studies. The Minimal Clinically Important Difference (MCID) of 13 mm on the VAS has been studied repeatedly and validated as the minimal VAS change needed for a patient to express significantly subjective improvements in pain (Gallagher, Leibman, and Bijur 2001)(Jensen and Chen 2003). Successful pain treatment has been shown by using 3-5 drops of 40% Rosa damascena oil on a cotton ball or gauze pad 20-30 cm from a patients face for 30 minutes (Bikmoradi et al. 2016). Additionally, uses of rescue medications and patient satisfaction have been commonly used as secondary measures in both aromatherapy and landmark back pain treatment studies. Patient demographics include age, gender, comorbidities, prior treatment, BMI, education, marital status, and pain identifiers have been repeatedly used to assess patient demographic distribution in many benchmark Emergency Medicine acute pain management studies (Chang et al 2015.)(Friedman et al. 2015).
D. Research Design and Methods
Rationale and Overview Isolated acute back pain (less than 2 weeks duration) and sciatica are common complaints to the emergency department requiring acute pain management with often chronic follow-up. Their abundance in the ED as well as poorly defined treatment recommendations make them an excellent candidate to study the use of aromatherapy in the emergency department. The authors will replicate the Rosa damascena trials referenced above in similar protocols, patients will be recruited if they fit the attached inclusion criteria and do not meet exclusion criteria. Patients will be treated with either Almond Oil extract or Rosa damascena extract, and both the investigator and patient will be blinded to the control arm. A VAS pain scale will be recorded before treatment, after 30 minutes of treatment, and after a following 2nd 30 minutes. Patients will additionally be asked about their satisfaction and subjective changes in pain, they will be blinded to their prior VAS line placements for proper evaluation of objective pain level changes. Demographics thought to contribute to the sensation of pain, expression of pain, and response to pain treatment will additionally be collected without entangling Private Health Information (PHI). Finally, the use of rescue medication such as NSAIDs or Narcotics at the treating physician's discretion will be recorded as an indicator of treatment failure and complication. Pain will be qualified in its type, locations, duration, immediate episodes prior to presentation, and prior remote episodes in the patient's lifetime health history. Pain will also be quantified by attempted at-home treatments prior to presentation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or above
- •Seen and attending or resident physician
- •Isolated back pain or sciatica
- •Pain lasting less than 2 weeks
- •Pain between lower scapular borders and gluteal folds
- •Patient maintains capacity and is interested in participating
排除标准
- •Pregnant patient, minor, or inmate patient
- •Patient lacks decision making capacity
- •Patient is delirious, demented, altered, intoxicated, or agitated
- •Patient allergic to Ibuprofen or NSAIDs
- •Patient unable to demonstrate understanding of experiment by teach-back method
- •Patient below age of 18
- •Physician, clinician, or investigator concern for underlying etiology other than isolated back pain or sciatica
- •Patient already received narcotics or requires immediate standard pain control
- •Patient demonstrated neurologic deficit or radicular symptoms
- •Patient does not wish to be studied
- •Patient endorses allergy to almond, roses, or perfumes
- •Patients with pain lasting greater than 2 weeks
结局指标
主要结局
Acute Pain Reduction
时间窗: 30 minutes, immediately after treatment
A 100 mm visual analog scale (VAS) for pain will be administered prior to and after treatment to assess for clinically significant pain control
次要结局
- Patient Satisfaction(30 minutes (immediately after) treatment)
- Patient Pain Toleration(30 minutes (immediately after) treatment)
- Patient Arm Belief(30 minutes (immediately after treatment))
研究者
Adam Singer
Principal Investigator and Vice Chair of EM Research
Stony Brook University