Aromatherapy Randomization of Pain Management in Adults

NCT03377088 | Suspended

• 1 other identifier: 1116889-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Back Pain, Low; Sciatica

Outcome Measures

Primary Outcomes (1)

• Acute Pain Reduction

  A 100 mm visual analog scale (VAS) for pain will be administered prior to and after treatment to assess for clinically significant pain control

  30 minutes, immediately after treatment

Secondary Outcomes (3)

• Patient Satisfaction

  30 minutes (immediately after) treatment

• Patient Pain Toleration

  30 minutes (immediately after) treatment

• Patient Arm Belief

  30 minutes (immediately after treatment)

Study Arms (2)

Almond Oil

PLACEBO COMPARATOR

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

Rose Oil

EXPERIMENTAL

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

Interventions

Rose oil OTHER

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.

Also known as: Rosa Damascena (Damask Rose) essential oil

Rose Oil

Almond Oil OTHER

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.

Also known as: Sweet almond oil

Almond Oil

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital Emergency Department

Stony Brook, New York, 11794, United States

Location

Related Publications (8)

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Bikmoradi A, Harorani M, Roshanaei G, Moradkhani S, Falahinia GH. The effect of inhalation aromatherapy with damask rose (Rosa damascena) essence on the pain intensity after dressing in patients with burns: A clinical randomized trial. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):247-54. doi: 10.4103/1735-9066.180380.

  PMID: 27186201 BACKGROUND

• Chang AK, Bijur PE, Holden L, Gallagher EJ. Comparative Analgesic Efficacy of Oxycodone/Acetaminophen Versus Hydrocodone/Acetaminophen for Short-term Pain Management in Adults Following ED Discharge. Acad Emerg Med. 2015 Nov;22(11):1254-60. doi: 10.1111/acem.12813. Epub 2015 Oct 19.

  PMID: 26479162 BACKGROUND

• Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.

  PMID: 26501533 BACKGROUND

• Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

  PMID: 11719741 BACKGROUND

• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• Marofi M, Sirousfard M, Moeini M, Ghanadi A. Evaluation of the effect of aromatherapy with Rosa damascena Mill. on postoperative pain intensity in hospitalized children in selected hospitals affiliated to Isfahan University of Medical Sciences in 2013: A randomized clinical trial. Iran J Nurs Midwifery Res. 2015 Mar-Apr;20(2):247-54.

  PMID: 25878704 BACKGROUND

• Mohebitabar S, Shirazi M, Bioos S, Rahimi R, Malekshahi F, Nejatbakhsh F. Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence. Avicenna J Phytomed. 2017 May-Jun;7(3):206-213.

  PMID: 28748167 BACKGROUND

MeSH Terms

Conditions

Back Pain; Low Back Pain; Sciatica

Interventions

Oils, Volatile; almond oil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Vice Chair of EM Research

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: December 11, 2017
• Primary Completion: March 31, 2019
• Study Completion: February 28, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)