Essential Oil for Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Interventions
- Other: usual care and topical essential copaiba oilOther: usual care and placebo treatmentOther: usual care
- Registration Number
- NCT05021146
- Lead Sponsor
- Buda Health Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care and CEO treatment with standard 20% concentration Copaiba oil usual care and topical essential copaiba oil - standard care and placebo treatment with coconut oil usual care and placebo treatment - Standard care usual care - Standard care and CEO treatment with 40% concentration Copaiba oil usual care and topical essential copaiba oil -
- Primary Outcome Measures
Name Time Method Pain intensity 6 months Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity
Function 6 months Oswestry Disability Index
- Secondary Outcome Measures
Name Time Method Psychological measurements- Depression 6 months Beck Depression Inventory
Psychological measurements- Pain catastrophization: 6 months Pain Catastrophizing Scale
Psychological measurements- Anxiety 6 months State-Trait Anxiety Inventory
Spinal function 6 months Timed Up and Go (TUG) test
Spinal active range of motion 6 months range of motion
Core Outcome Measures Index Back (COMI Back) 6 months 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).
Quality of Life 6 months EuroQoL-5D
Psychological measurements- Fear Avoidance Beliefs 6 months Fear Avoidance Beliefs Questionnaire
Global treatment outcome 6 months 7- point Likert scale ( higher numbers representing worse the outcome)
Patient satisfaction 6 months 5- point Likert scale (smaller number represent more satisfied patients)
Demand of treatment 6 months Pain medication and applied therapies after discharge
Trial Locations
- Locations (1)
National Center for Spinal Disorders / Buda Health Center
🇭🇺Budapest, Hungary