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| Name | Class |
|---|---|
| dōTERRA International | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care and CEO treatment with standard 20% concentration Copaiba oil | Experimental |
| |
| Standard care and CEO treatment with 40% concentration Copaiba oil | Experimental |
| |
| standard care and placebo treatment with coconut oil | Placebo Comparator |
| |
| Standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| usual care and topical essential copaiba oil | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aron Lazary, PhD | Contact | +3618877900 | aron.lazary@bhc.hu | |
| Julia Szita, PhD | Contact | +3618877900 | 5670 | julia.szita@bhc.hu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Pal Varga, MD | Buda Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Spinal Disorders / Buda Health Center | Recruiting | Budapest | 1126 | Hungary |
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|
| usual care and placebo treatment | Other | 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). |
|
| usual care | Other | All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay. |
|
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 |