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ECAP: Essential Oil for Chronic Low Back Pain

Sponsor
Buda Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05021146
Collaborator
dōTERRA International (Industry)
300
Enrollment
1
Location
4
Arms
18.9
Anticipated Duration (Months)
15.9
Patients Per Site Per Month

Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Other: usual care and topical essential copaiba oil
  • Other: usual care and placebo treatment
  • Other: usual care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Essential Oil for Chronic Low Back Pain
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard care and CEO treatment with standard 20% concentration Copaiba oil

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).
Experimental: Standard care and CEO treatment with 40% concentration Copaiba oil

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).
Placebo Comparator: standard care and placebo treatment with coconut oil

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).
Active Comparator: Standard care

Other: usual care
All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [6 months]

    Visual Analogue Scale measured on a scale 0-10 where the higher the number the worse the pain intensity

  2. Function [6 months]

    Oswestry Disability Index

Secondary Outcome Measures

  1. Core Outcome Measures Index Back (COMI Back) [6 months]

    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).

  2. Quality of Life [6 months]

    EuroQoL-5D

  3. Psychological measurements- Fear Avoidance Beliefs [6 months]

    Fear Avoidance Beliefs Questionnaire

  4. Psychological measurements- Depression [6 months]

    Beck Depression Inventory

  5. Psychological measurements- Pain catastrophization: [6 months]

    Pain Catastrophizing Scale

  6. Psychological measurements- Anxiety [6 months]

    State-Trait Anxiety Inventory

  7. Spinal function [6 months]

    Timed Up and Go (TUG) test

  8. Spinal active range of motion [6 months]

    range of motion

  9. Global treatment outcome [6 months]

    7- point Likert scale ( higher numbers representing worse the outcome)

  10. Patient satisfaction [6 months]

    5- point Likert scale (smaller number represent more satisfied patients)

  11. Demand of treatment [6 months]

    Pain medication and applied therapies after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Center for Spinal Disorders / Buda Health Center Budapest Hungary 1126

Sponsors and Collaborators

  • Buda Health Center
  • dōTERRA International

Investigators

  • Principal Investigator: Peter Pal Varga, MD, Buda Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buda Health Center
ClinicalTrials.gov Identifier:
NCT05021146
Other Study ID Numbers:
  • DO-221014-COP
First Posted:
Aug 25, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Oct 15, 2021