Clinical trial NCT05021146: Essential Oil for Chronic Low Back Pain
Official title: Essential Oil for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Buda Health Center
Sponsor class: OTHER
Collaborators: name: dōTERRA International
First posted: 2021-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 6 months
measure: Function
timeFrame: 6 months
Secondary outcomes:
measure: Core Outcome Measures Index Back (COMI Back)
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Psychological measurements- Fear Avoidance Beliefs
timeFrame: 6 months
measure: Psychological measurements- Depression
timeFrame: 6 months
measure: Psychological measurements- Pain catastrophization:
timeFrame: 6 months
measure: Psychological measurements- Anxiety
timeFrame: 6 months
measure: Spinal function
timeFrame: 6 months
measure: Spinal active range of motion
timeFrame: 6 months
measure: Global treatment outcome
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Demand of treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders / Buda Health Center
Study officials:
affiliation: Buda Health Center
name: Peter Pal Varga, MD
role: PRINCIPAL_INVESTIGATOR
References: