Essential Oil for Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

— ECAP  

Official title:

Essential Oil for Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021146
• Other study ID #: DO-221014-COP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2021
• Source: Buda Health Center
• Contact: Aron Lazary, PhD
• Phone: +3618877900
• Email: aron.lazary[@]bhc.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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).
• 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.

Locations

Country	Name	City	State
Hungary	National Center for Spinal Disorders / Buda Health Center	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Buda Health Center	doTERRA International

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity	6 months
Primary	Function	Oswestry Disability Index	6 months
Secondary	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
Secondary	Quality of Life	EuroQoL-5D	6 months
Secondary	Psychological measurements- Fear Avoidance Beliefs	Fear Avoidance Beliefs Questionnaire	6 months
Secondary	Psychological measurements- Depression	Beck Depression Inventory	6 months
Secondary	Psychological measurements- Pain catastrophization:	Pain Catastrophizing Scale	6 months
Secondary	Psychological measurements- Anxiety	State-Trait Anxiety Inventory	6 months
Secondary	Spinal function	Timed Up and Go (TUG) test	6 months
Secondary	Spinal active range of motion	range of motion	6 months
Secondary	Global treatment outcome	7- point Likert scale ( higher numbers representing worse the outcome)	6 months
Secondary	Patient satisfaction	5- point Likert scale (smaller number represent more satisfied patients)	6 months
Secondary	Demand of treatment	Pain medication and applied therapies after discharge	6 months