Aromatherapy Randomization of Pain Management in Adults

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

Interventions

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

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.

Sponsors & Collaborators

• Stony Brook University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-11

Primary Completion

2019-03-31

Completion

2024-02-28

Countries

• United States

Study Locations