Chronic Low-back PainECAPNCT05021146
Essential Oil for Chronic Low Back Pain
A study of Chronic Low-back Pain, run by Buda Health Center at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous spinal surgery
- Untreated metabolic bone disease
- Active malignant disease
- Pregnancy
- Severe osteoporosis, fracture or posttraumatic deformity
- Spinal infection
Show all 14Show fewer
- Neuromuscular disease
- Autoimmune disease
- Myelopathy
- Congenital spinal deformity
- Mental disorders
- Severe sciatica
- Severe spinal instability
- Refusing the study protocol
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
National Center for Spinal Disorders / Buda Health Center
Budapest, 1126
Aron Lazary, PhD, +3618877900, aron.lazary@bhc.hu
Julia Szita, PhD, +3618877900, julia.szita@bhc.hu
About this study
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- usual care and topical essential copaiba oil, usual care and placebo treatment, usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual care and topical essential copaiba oilOther
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 treatmentOther
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 careOther
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Standard care and CEO treatment with standard 20% concentration Copaiba oil | Experimental | Not described Receives: Other: usual care and topical essential copaiba oil |
| Standard care and CEO treatment with 40% concentration Copaiba oil | Experimental | Not described Receives: Other: usual care and topical essential copaiba oil |
| standard care and placebo treatment with coconut oil | Placebo comparator | Not described Receives: Other: usual care and placebo treatment |
| Standard care | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity
Measured: 6 months
Function
Oswestry Disability Index
Measured: 6 months
Secondary outcomes (11)
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).
Measured: 6 months
Quality of Life
EuroQoL-5D
Measured: 6 months
Psychological measurements- Fear Avoidance Beliefs
Fear Avoidance Beliefs Questionnaire
Measured: 6 months
Psychological measurements- Depression
Beck Depression Inventory
Measured: 6 months
Psychological measurements- Pain catastrophization:
Pain Catastrophizing Scale
Measured: 6 months
Psychological measurements- Anxiety
State-Trait Anxiety Inventory
Measured: 6 months
Spinal function
Timed Up and Go (TUG) test
Measured: 6 months
Spinal active range of motion
range of motion
Measured: 6 months
Global treatment outcome
7- point Likert scale ( higher numbers representing worse the outcome)
Measured: 6 months
Patient satisfaction
5- point Likert scale (smaller number represent more satisfied patients)
Measured: 6 months
Demand of treatment
Pain medication and applied therapies after discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buda Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- dōTERRA International
- Responsible party
- Sponsor
- Investigators
- Peter Pal Varga, MD, Principal investigator, Buda Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021146
- Sponsor's protocol ID
- DO-221014-COP
- Acronym
- ECAP
- Status last verified
- Oct 2021
- First submitted
- 18 Aug 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Oil for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05021146
- Acronym / sponsor ID
- ECAP / DO-221014-COP
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Buda Health CenterUniversity, hospital or other
- Collaborators
- dōTERRA International
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard care and CEO treatment with standard 20% concentration Copaiba oil | Experimental | Other: usual care and topical essential copaiba oil |
| Standard care and CEO treatment with 40% concentration Copaiba oil | Experimental | Other: usual care and topical essential copaiba oil |
| standard care and placebo treatment with coconut oil | Placebo comparator | Other: usual care and placebo treatment |
| Standard care | Active comparator | Other: usual care |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Previous spinal surgery
- Untreated metabolic bone disease
- Active malignant disease
- Pregnancy
- Severe osteoporosis, fracture or posttraumatic deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual care and topical essential copaiba oilAll 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 | Standard care and CEO treatment with 40% concentration Copaiba oil, Standard care and CEO treatment with standard 20% concentration Copaiba oil |
| usual care and placebo treatmentAll 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 | standard care and placebo treatment with coconut oil |
| usual careAll subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay. | Other | Standard care |
Primary outcome
Pain intensity
Time frame: 6 months
Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity
Function
Time frame: 6 months
Oswestry Disability Index
11 secondary outcomes
Core Outcome Measures Index Back (COMI Back)
Time frame: 6 months
Quality of Life
Time frame: 6 months
Psychological measurements- Fear Avoidance Beliefs
Time frame: 6 months
Psychological measurements- Depression
Time frame: 6 months
Psychological measurements- Pain catastrophization:
Time frame: 6 months
Psychological measurements- Anxiety
Time frame: 6 months
Spinal function
Time frame: 6 months
Spinal active range of motion
Time frame: 6 months
Global treatment outcome
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Demand of treatment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pal Varga, MD principal investigator
Buda Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Low-back Pain, run by Buda Health Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aron Lazary, PhD (+3618877900, aron.lazary@bhc.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.