Chronic Low-back Pain
Conditions
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.
Interventions
OTHERusual 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).
OTHERusual 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).
OTHERusual care
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
Sponsors
dōTERRA International
Buda Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Psychological measurements- Fear Avoidance Beliefs | 6 months | Fear Avoidance Beliefs Questionnaire |
| 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 |
| 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). |
| Spinal active range of motion | 6 months | range of motion |
| 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 |
| Spinal function | 6 months | Timed Up and Go (TUG) test |
| Quality of Life | 6 months | EuroQoL-5D |
Countries
Hungary
Contacts
Primary ContactAron Lazary, PhD
Backup ContactJulia Szita, PhD
Outcome results
None listed