Essential Oil for Chronic Low Back Pain (ECAP)
Primary Purpose
Chronic Low-back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
usual care and topical essential copaiba oil
usual care and placebo treatment
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
Eligibility Criteria
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
Sites / Locations
- National Center for Spinal Disorders / Buda Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Standard care and CEO treatment with standard 20% concentration Copaiba oil
Standard care and CEO treatment with 40% concentration Copaiba oil
standard care and placebo treatment with coconut oil
Standard care
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity
Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity
Function
Oswestry Disability Index
Secondary Outcome Measures
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).
Quality of Life
EuroQoL-5D
Psychological measurements- Fear Avoidance Beliefs
Fear Avoidance Beliefs Questionnaire
Psychological measurements- Depression
Beck Depression Inventory
Psychological measurements- Pain catastrophization:
Pain Catastrophizing Scale
Psychological measurements- Anxiety
State-Trait Anxiety Inventory
Spinal function
Timed Up and Go (TUG) test
Spinal active range of motion
range of motion
Global treatment outcome
7- point Likert scale ( higher numbers representing worse the outcome)
Patient satisfaction
5- point Likert scale (smaller number represent more satisfied patients)
Demand of treatment
Pain medication and applied therapies after discharge
Full Information
NCT ID
NCT05021146
First Posted
August 18, 2021
Last Updated
October 7, 2021
Sponsor
Buda Health Center
Collaborators
dōTERRA International
1. Study Identification
Unique Protocol Identification Number
NCT05021146
Brief Title
Essential Oil for Chronic Low Back Pain
Acronym
ECAP
Official Title
Essential Oil for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buda Health Center
Collaborators
dōTERRA International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care and CEO treatment with standard 20% concentration Copaiba oil
Arm Type
Experimental
Arm Title
Standard care and CEO treatment with 40% concentration Copaiba oil
Arm Type
Experimental
Arm Title
standard care and placebo treatment with coconut oil
Arm Type
Placebo Comparator
Arm Title
Standard care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
usual care and topical essential copaiba oil
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
usual care and placebo treatment
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity
Time Frame
6 months
Title
Function
Description
Oswestry Disability Index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Core Outcome Measures Index Back (COMI Back)
Description
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).
Time Frame
6 months
Title
Quality of Life
Description
EuroQoL-5D
Time Frame
6 months
Title
Psychological measurements- Fear Avoidance Beliefs
Description
Fear Avoidance Beliefs Questionnaire
Time Frame
6 months
Title
Psychological measurements- Depression
Description
Beck Depression Inventory
Time Frame
6 months
Title
Psychological measurements- Pain catastrophization:
Description
Pain Catastrophizing Scale
Time Frame
6 months
Title
Psychological measurements- Anxiety
Description
State-Trait Anxiety Inventory
Time Frame
6 months
Title
Spinal function
Description
Timed Up and Go (TUG) test
Time Frame
6 months
Title
Spinal active range of motion
Description
range of motion
Time Frame
6 months
Title
Global treatment outcome
Description
7- point Likert scale ( higher numbers representing worse the outcome)
Time Frame
6 months
Title
Patient satisfaction
Description
5- point Likert scale (smaller number represent more satisfied patients)
Time Frame
6 months
Title
Demand of treatment
Description
Pain medication and applied therapies after discharge
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aron Lazary, PhD
Phone
+3618877900
Email
aron.lazary@bhc.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Szita, PhD
Phone
+3618877900
Ext
5670
Email
julia.szita@bhc.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Pal Varga, MD
Organizational Affiliation
Buda Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Spinal Disorders / Buda Health Center
City
Budapest
ZIP/Postal Code
1126
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aron Lazary, PhD
Phone
+3618877900
Email
aron.lazary@bhc.hu
First Name & Middle Initial & Last Name & Degree
Julia Szita, PhD
Phone
+3618877900
Email
julia.szita@bhc.hu
First Name & Middle Initial & Last Name & Degree
Peter Pal Varga, MD
First Name & Middle Initial & Last Name & Degree
Julia Szita, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Essential Oil for Chronic Low Back Pain
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