Essential Oil for Chronic Low Back Pain

Study Overview
=================
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: 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 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.

Official Title
-----------------
Essential Oil for Chronic Low Back Pain

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: usual care and topical essential copaiba oil
* Other: usual care and placebo treatment
* Other: usual care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care and CEO treatment with standard 20% concentration Copaiba oil<br> | Other: usual care and topical essential copaiba oil<br>* 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).<br>|
| Experimental: Standard care and CEO treatment with 40% concentration Copaiba oil<br> | Other: usual care and topical essential copaiba oil<br>* 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).<br>|
| Placebo Comparator: standard care and placebo treatment with coconut oil<br> | Other: usual care and placebo treatment<br>* 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).<br>|
| Active Comparator: Standard care<br> | Other: usual care<br>* All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.<br>|

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 |