NCT05021146

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. 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. 2.Reduce the chronic health burden on society associated with treatment, sick leave, rehabilitation, and involuntary retirement, by reducing health-related costs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

August 18, 2021

Last Update Submit

October 7, 2021

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

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

    6 months

  • Function

    Oswestry Disability Index

    6 months

Secondary Outcomes (11)

  • Core Outcome Measures Index Back (COMI Back)

    6 months

  • Quality of Life

    6 months

  • Psychological measurements- Fear Avoidance Beliefs

    6 months

  • Psychological measurements- Depression

    6 months

  • Psychological measurements- Pain catastrophization:

    6 months

  • +6 more secondary outcomes

Study Arms (4)

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

Interventions

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).

Standard care and CEO treatment with 40% concentration Copaiba oilStandard care and CEO treatment with standard 20% concentration Copaiba oil
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).

standard care and placebo treatment with coconut oil
usual careOTHER

All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.

Standard care

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Spinal Disorders / Buda Health Center

Budapest, 1126, Hungary

RECRUITING

Study Officials

  • Peter Pal Varga, MD

    Buda Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aron Lazary, PhD

CONTACT

+3618877900aron.lazary@bhc.hu

Julia Szita, PhD

CONTACT

+3618877900julia.szita@bhc.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 25, 2021

Study Start

September 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)