Essential Oil for Chronic Low Back Pain (ECAP)

Buda Health Center

Status: Unknown

Conditions: Chronic Low-back Pain

Treatments: Other: usual care and placebo treatment; Other: usual care; Other: usual care and topical essential copaiba oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05021146

DO-221014-COP

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

Standard care and CEO treatment with standard 20% concentration Copaiba oil

Experimental group

Treatment:

Other: usual care and topical essential copaiba oil

Standard care and CEO treatment with 40% concentration Copaiba oil

Experimental group

Treatment:

Other: usual care and topical essential copaiba oil

standard care and placebo treatment with coconut oil

Placebo Comparator group

Treatment:

Other: usual care and placebo treatment

Standard care

Active Comparator group

Treatment:

Other: usual care