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Aromatherapy Randomization of Pain Management in Adults (AROMA)

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ClinicalTrials.gov Identifier: NCT03377088
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Back Pain Back Pain, Low Sciatica Other: Rose oil Other: Almond Oil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aromatherapy for Management of Back Pain in the Emergency Department
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Almond Oil
Patients will be given Almond Oil for inhalation on cotton balls as a control. Almond Oil has been shown to act as a placebo when compared to our variable, Rosa Damascena oil. To ensure blinding, this arm will act to always deliver a scent to a patient, blinding them to whether they are receiving a known aromatherapy or a common scent.
Other: Almond Oil
Almond Oil has been shown in limited studies to act as a placebo for pain control when compared to Rose Oil. This subtly sweet oil will be used to ensure the patient always receives a smell, and maintains blinding.
Other Name: Sweet almond oil

Experimental: Rose Oil
Patients will be given Rosa Damascena oil on cottons balls as a variable. This oil has been shown to significantly lower acute pain levels on the visual analog pain scale when compared to placebo of distilled water or Almond Oil.
Other: Rose oil
Rose oil will be given as the intervention in this study, an over-the-counter agent that can be commonly found in retail stores. It will be delivered as 2 drops 50% rose oil in water on a cotton ball within 20 cm of the patient's face for 30 minutes.
Other Name: Rosa Damascena (Damask Rose) essential oil




Primary Outcome Measures :
  1. Acute Pain Reduction [ Time Frame: 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


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 30 minutes (immediately after) treatment ]
    Patients will be asked after treatment how satisfied they are with their treatment on a 5 point likert scale

  2. Patient Pain Toleration [ Time Frame: 30 minutes (immediately after) treatment ]
    Patients will be asked to subjectively report changes in their pain after completing a VAS pain scale on a 5 point likert scale

  3. Patient Arm Belief [ Time Frame: 30 minutes (immediately after treatment) ]
    Patients will be asked if they think the agent they received was in fact the experimental scent or not, and whether they would consider using it again for future pain control.



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377088


Contacts
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Contact: Stephen G Meigher, BA 518-937-3489 stephen.meigher@stonybrookmedicine.edu
Contact: Adam J Singer, MD 631-444-7857 adam.singer@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Hospital Emergency Department Recruiting
Stony Brook, New York, United States, 11794
Contact: Stephen G Meigher, BA    518-937-3489    stephen.meigher@stonybrookmedicine.edu   
Contact: Adam J Singer, MD    6314447857    adam.singer@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
  Study Documents (Full-Text)

Documents provided by Adam Singer, Stony Brook University:
Informed Consent Form  [PDF] December 12, 2017


Publications:

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Responsible Party: Adam Singer, Principal Investigator and Vice Chair of EM Research, Stony Brook University
ClinicalTrials.gov Identifier: NCT03377088     History of Changes
Other Study ID Numbers: 1116889-3
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Sciatica
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia