Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-09-01
2023-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard care and CEO treatment with standard 20% concentration Copaiba oil
usual 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).
Standard care and CEO treatment with 40% concentration Copaiba oil
usual 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).
standard care and placebo treatment with coconut oil
usual 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).
Standard care
usual care
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
Interventions
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usual 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).
usual 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).
usual care
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
No
Sponsors
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dÅTERRA International
INDUSTRY
Buda Health Center
OTHER
Responsible Party
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Principal Investigators
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Peter Pal Varga, MD
Role: PRINCIPAL_INVESTIGATOR
Buda Health Center
Locations
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National Center for Spinal Disorders / Buda Health Center
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DO-221014-COP
Identifier Type: -
Identifier Source: org_study_id