Aromatherapy for Management of Back Pain in the Emergency Department
Phase: NA
Conditions: Back Pain, Back Pain, Low, Sciatica
Sponsor: Stony Brook University

 
 
 
Protocol Template Guidance 
For Submissions to CORIHS 
 
TITLE:  Aromatherapy for management of back pain in the Emergency Department 
 
INVESTIGATORS:  Adam Singer MD / Sarah Weiss MD / Stephen Meigher BS 
 
Department of Emergency Medicine 
 
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.  We 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.  We 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 ().  Our 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.  Our secondary measures 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 damascene (Damask Rose) essential oil.  
Rosa damascene is believed to possess anti-anxiolytic, sedative, anticonvulsive, and analgesic effect 
on the 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 damascene 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.  We 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 damascene 
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 damascene have been cited above and will be presented in the 
references section.  We 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.  Our 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 damascene 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.  We will replicate the Rosa 
damascene 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 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.   
 
Research Site 
The entirety of this prospective clinical trial will be conducted at the Stony Brook Hospital Emergency 
Department, an ED with over 80,000 annual visits.   
 
Study Sample 
Patients will be recruited into this study by an investigator in the Stony Brook Emergency Department.  
A sample size was calculated to be 30 patients for each treatment arm based on a power of 0.80, 
desired p value below 0.05, and 95% confidence intervals with the anticipated possibility of patient loss 
or desire to withdraw during treatment. Patients will be approached for recruitment after an attending or 
resident physician has seen them and does not anticipate immediate need for narcotic pain medication, 
immediate imaging, or immediate threats to life or limb.  Patients will be included by the attached 
inclusion and exclusion criteria.  Double-blinding will be ensured by block randomization of each 
treatment arm, performed outside of the emergency department.  In the Emergency Department 
Research Offices, the two treatment arms will be allocated into identical, individual vessels with only a 
codified label applied to each.  Using block randomization, 30 treatments will be distributed to each arm 
in secret by a clinical research assistant or Dr. Singer.  Each treatment will be codified individually and 
recorded in secrecy and kept from the investigators, Dr. Weiss and Stephen Meigher.  Randomization 
will then arrange the total 60 treatments in longitudinal order for sequential random treatments to be 
selected as each patient is recruited.   
 
Screening  
Patients will be approached in private and the name, title, and role of the investigator explained after 
asking permission to speak with the patient. The patient will be told that we are conducting a clinical 
research trial for the treatment of acute back pain and sciatica. Aromatherapy will be explained as the 
treatment of interest and a modality that has been tested and proven in other types of pain.  The use of 
Almond products and Rose products will be briefly discussed with the patients. Patient’s will be asked 
about any allergies and then asked specifically about allergies to Almonds, Roses, perfume, and 
ibuprofen. Patient will be informed that speaking with the investigator is entirely optional, as is 
participating in the study, as there may be no direct benefit to them despite disclosure of their private 
information to the investigator. An Inclusion and Exclusion form will be reviewed with the patient and 

 
 
 
their chart, noting their sequential patient number in this study as the only de-identified patient ID.  No 
PMI will be collected; no MRN, address, phone number, emails, name, SSN, DOB, chief complaint, 
PMH, PSH, or medications will be recorded. The risks and benefits will be explained to the patient 
including risk of allergy, risk of no change in pain, benefit of pain improvement, and benefit of 
contribution to medical research. The consent form will be reviewed in full and any questions answered. 
Those patients interested in participating and able to grant consent will do so. 
 
Procedures 
Rosa damascena 40% and Almond Oil 40% kept outside of the ED will be prepared each day and 
dispersed into identical vessels with randomized identification numbers.  The coded numbers and their 
respective modality will be recorded by an investigator not involved in delivery and kept secured.  
Patients will be chosen into random treatment arms by block randomization and their coded treatment 
recorded on the patient data sheet. Patients will be given 4 drops of either modality (40%) on a cotton 
ball kept between 20 and 30 cm from their face for 30 minutes. 
 
With regards to study blinding, the treatments will be randomly assigned and the patients will not be 
told which treatment they are receiving. The patients will be aware that the study involves Rose and 
Almond scents and will likely be able to identify the scent used in their treatment. However, at the end 
of the study procedures, an independent observer will assess the patient’s pain after the aromatherapy 
has been removed from the room, and will not be aware of which patients received which treatment. 
 
E. Statistics 
VAS differences immediately after treatment and 30-minutes following will be aggregated from their 
respective 100 mm VAS for pain and the change calculated for each patient.  One-tailed paired t-Tests 
will be then conducted on the means after standard deviation is calculated and compared between 
treatment and control groups.  A chi-squared test will then be applied between both groups for analysis 
of significant differences in patient satisfaction and subjective reports of pre- and post-treatment pain.  
The use of rescue medications by type and dosage will be measured as a percentage of each group 
and compared via t-Test between both groups.   
 
F. Funding 
Rosa damascene and Almond Oil are affordable and readily available over-the-counter.  This trial 
requires no significant funding to be conducted.   
 
G. HUMAN SUBJECTS RESEARCH PROTECTION FROM RISK 
 
Risk to Subjects 
This study poses minimal risks to its enrolled subjects.  Subjects will not be exposed to systemic 
treatments.  Their anticipated risks include failure to control pain, dislike of the randomized 
aromatherapy agent, and (rare) allergic reaction.  The former will be reduced by screening for allergies 
to flowers, almonds, or perfumes.   
 
Adequacy of Protection Against Risks 
Patients are well-protected against the aforementioned risks.  Rescue medications will be used at the 
treating physician’s discretion for those patients without proper pain control as a result of the trial.  
Patients with allergies are anticipated to be extremely rare and will be screened out by questionnaire 
and inclusion/exclusion criteria.  The study will be conducted entirely in the Emergency Department, 
where physicians and nurses trained in emergency medicine are available to treat any unforeseeable 
risk such as anaphylaxis.   
 
Potential Benefits of Proposed Research to the Subjects and Others 
Patients may benefit directly fro this study through relief of their acute pain. The benefit to society will 
be that of the evaluation of aromatherapy as a pain management tool in the emergency department.  
This research will answer if it is an appropriate modality for the emergency department and whether its 
evidence elsewhere is applicable and warrants further study. 
 

 
 
 
Importance of the Knowledge to be Gained 
The knowledge gained in this trial may provide a groundwork for future use of aromatherapy treatment 
of acute pain in the emergency department.  In the very least, it will demonstrate whether prior 
aromatherapy using Rosa damascena are externally valid and worth further research or not 
reproducible in the acute back pain patient.   
 
H. Literature Cited 
Bijur, Silver, and Gallagher.  2001.  Reliability of the Visual Analog Scale for Measurement of Acute 
Pain.  Academic Emergency Medicine 8(12): 1154-1157 
 
Bikmoradi et al.  2016.  The Effect of Inhalation Aromatherapy with Damask Rose (Rosa damascene) 
Essence on Pain Intensity after Dressing in Patients with Burns: A clinical Randomized Trial.  Iranian 
Journal of Nursing and Midwifery Research 21(3):247-254 
 
Chang et al.  2015.  Comparative Analgesic Efficacy of Oxycodone/Acetaminophen Versus 
Hydrocodone/Acetaminophen for Short-Term Pain Management in Adults following ED Discharge. 
Academic Emergency Medicine 22(11):1254-1260 
 
Friedman et al. 2015.  Naproxen with cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for 
Treating Acute Low Back Pain: A Randomized Clinical Trial.  JAMA 314(15):1572-1580 
 
Gallagher, Liebman, and Bijur.  2001.  Prospective Validation of Clinically Important Changes in Pain 
Severity Measured on a Visual Analog Scale.  Annals of Emergency Medicine (38(6): 633-638 
 
Jensen and Chen.  2003.  Interpretation of Visual Analog Scale Ratings and change Scores: A 
Reanalysis of Two Clinical Trials of Postoperative Pain.  Journal of Pain 4(7): 407-414 
 
Marofi et al. 2015.  Evaluation of the Effect of Aromatherapy with Rosa damascene Mill. On 
Postoperative Pain Intensity in Hospitalized Children in Selected Hospitals Affiliated to Isfahan 
University of Medical Sciences in 2013: A Randomized Clinical Trial.  Iranian Journal of Nursing and 
Midwifery Research 20(2):247-254 
 
Mohebitabar et al.  2016.  Therapeutic Efficacy of Rose Oil: A Comprehensive Review of Clinical 
Evidence.  Avicenna Journal of Phytomedicine 7(3):206-213