NCT05021146

Essential Oil for Chronic Low Back Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Buda Health Center · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
OTHER	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).
OTHER	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).
OTHER	usual care	All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-08-25
• Last updated: 2021-10-15

Locations

1 site across 1 country: Hungary