Essential Oil for Chronic Low Back Pain (ECAP)

The specific objective of this study is to assess the safety and clinical efficacy of a new individualised spinal rehabilitation programme involving copaiba essential oil (CEO) therapy compared to usual care for people with chronic low back pain. Research in complementary and alternative medicine has increased over the last 15 years. As biochemical research shows, these substances carry the ability to relieve pain and to reduce inflammation. In doing so, it aims to:

1. Improve the health outcomes for individuals with chronic low back pain (CLBP) by positively impacting their pain, disability, work capacity, physical activity and mental health, and
2. Reduce the chronic health burden on society associated with treatment, sick leave, rehabilitation, and involuntary retirement, by reducing health-related costs.

The primary clinical hypothesis is that patients with CLBP receiving individualised spinal care and additional CEO topical treatment will have superior short- and long-term outcome (defined by condition specific quality of life and general well-being) compared to usual care.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: usual care and topical essential copaiba oil; Other: usual care and placebo treatment; Other: usual care

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aron Lazary, PhD; Phone Number: +3618877900; Email: aron.lazary@bhc.hu
• Study Contact Backup: Name: Julia Szita, PhD; Phone Number: 5670 +3618877900; Email: julia.szita@bhc.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1126
    • Recruiting
    • National Center for Spinal Disorders / Buda Health Center
    • Contact: Aron Lazary, PhD; Phone Number: +3618877900; Email: aron.lazary@bhc.hu
    • Contact: Julia Szita, PhD; Phone Number: +3618877900; Email: julia.szita@bhc.hu
    • Principal Investigator: Peter Pal Varga, MD
    • Sub-Investigator: Julia Szita, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic low back pain with or without irradiating pain (pain > 3 months)
• Low back pain is the dominant symptom, and Visual Analog Pain Scale (low back pain)>4
• Normal cognitive function, voluntary participation
• Able to read and answer the questionnaires in English or Hungarian language

Exclusion Criteria:

• Previous spinal surgery
• Untreated metabolic bone disease
• Active malignant disease
• Pregnancy
• Severe osteoporosis, fracture or posttraumatic deformity
• Spinal infection
• Neuromuscular disease
• Autoimmune disease
• Myelopathy
• Congenital spinal deformity
• Mental disorders
• Severe sciatica
• Severe spinal instability
• Refusing the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard care	Other: usual care; All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
EXPERIMENTAL: Standard care and CEO treatment with standard 20% concentration Copaiba oil	Other: usual care and topical essential copaiba oil; All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay including a daily 30 minute massage therapy. Both experimental groups and the placebo group patients continue to use topical treatment in the first half of the follow up period (90 days).
EXPERIMENTAL: Standard care and CEO treatment with 40% concentration Copaiba oil	Other: usual care and topical essential copaiba oil; All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay including a daily 30 minute massage therapy. Both experimental groups and the placebo group patients continue to use topical treatment in the first half of the follow up period (90 days).
PLACEBO_COMPARATOR: standard care and placebo treatment with coconut oil	Other: usual care and placebo treatment; All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay including a daily 30 minute massage therapy. Both experimental groups and the placebo group patients continue to use topical treatment in the first half of the follow up period (90 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity	6 months
Function	Oswestry Disability Index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Outcome Measures Index Back (COMI Back)	A brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability).	6 months
Quality of Life	EuroQoL-5D	6 months
Psychological measurements- Fear Avoidance Beliefs	Fear Avoidance Beliefs Questionnaire	6 months
Psychological measurements- Depression	Beck Depression Inventory	6 months
Psychological measurements- Pain catastrophization:	Pain Catastrophizing Scale	6 months
Psychological measurements- Anxiety	State-Trait Anxiety Inventory	6 months
Spinal function	Timed Up and Go (TUG) test	6 months
Spinal active range of motion	range of motion	6 months
Global treatment outcome	7- point Likert scale ( higher numbers representing worse the outcome)	6 months
Patient satisfaction	5- point Likert scale (smaller number represent more satisfied patients)	6 months
Demand of treatment	Pain medication and applied therapies after discharge	6 months

Collaborators and Investigators

• Sponsor: Buda Health Center
• Collaborators: dōTERRA International
• Investigators: Principal Investigator: Peter Pal Varga, MD, Buda Health Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (ACTUAL): August 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DO-221014-COP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No