Chronic Low Back Pain (CLBP)TMLBPNCT06627101
Traditional Medicine Use in Low Back Pain
An observational study of Chronic Low Back Pain (CLBP), run by Federal University of Amapa.
Trial summary
Chronic low back pain (CLBP) is classified as one of the leading causes of disability worldwide. Furthermore, the painful experience of CLBP can be influenced by some already established factors, such as beliefs, self-efficacy, and kinesiophobia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2024to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include individuals over 18 years of age, of both genders, diagnosed with chronic low back pain, who have had pain for at least three months, and who are natives of the Northern region of Brazil.
Who may be able to join
- individuals over 18 years of age
- both genders
- diagnosed with chronic low back pain
- who have had pain for at least three months
- who are natives of the Northern region of Brazil
Who cannot join
- Individuals with low back pain of oncological origin
- recent traumas that may have caused the pain (such as falls, car accidents, and fractures)
- patients in the postoperative period
- bedridden patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Traditional Medicine Use in Patients With Chronic Low Back Pain in Northern Brazil: a Cross-sectional
Chronic low back pain (CLBP) is classified as one of the leading causes of disability worldwide. Furthermore, the painful experience of CLBP can be influenced by some already established factors, such as beliefs, self-efficacy, and kinesiophobia. Beliefs are pre-established ideas that can influence physical functionality, pain experience, social functioning, and adherence to CLBP treatment Clique ou toque aqui para inserir o texto. Among them is Traditional Medicine, a practice carried out by some populations that continue to trust their own popular medicine to meet their health demands. According to the WHO, Traditional Medicine (MT) or Popular Medicine (MP) is a practice reproduced in different cultures and based on beliefs, the sum of experiences and knowledge, whose objective is to prevent, treat or cure illnesses, whether physical or mental. This habit includes the use of home remedies, which are based on the manipulation of plant, animal, and mineral extracts for therapeutic purposes. Furthermore, it is important to point out that, as it is a chronic condition, individuals living with CLBP are strongly influenced by psychological factors, such as kinesiophobia (avoidance of exercise), catastrophizing (intensifying fear of movement, as they feel that pain is a threat), and low self-efficacy in processing and modulating pain, increasing levels of pain and disability. Also, in addition to this, socioeconomic level is one of the determinants of the incidence and intensity of chronic pain. In short, although the practice of TM has been recognized for decades, it is not known whether there is a relationship between this belief and the levels of self-efficacy, kinesiophobia and catastrophizing of individuals with CLBP in Northern Brazil. Therefore, this study aims to identify the use of TM and its impacts on the functional activities and quality of life of individuals with CLBP in the northern region of Brazil. This is a cross-sectional observational study. Individuals participating in this research will be invited to respond online to the questionnaire prepared by the authors of this study. Continuous data will be analyzed descriptively using mean and standard deviation; categorical data will be described in frequency form, and the normality of the data will be analyzed to identify the possibility of using parametric or non-parametric statistical tests.
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- Traditional Medicine, Beliefs, Lower back pain.
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Traditional Medicine
a practice still relied upon by certain populations that continue to trust their own folk medicine to address their health needs
Measured: 1 day
Secondary outcomes (2)
functionality
the Oswestry Disability Index (ODI) questionnaire will be used. The instrument can be self-administered or administered through an interview, consisting of a series of 10 questions that address pain intensity and difficulties in daily life activities.
Measured: 1 day
Self-Efficacy Assessment
The Chronic Pain Self-Efficacy Scale (AEDC) will be used, validated in Brazil. It is a specific scale for measuring the perception of self-efficacy and the ability to cope with the consequences of pain in patients with chronic pain. It consists of 22 items divided into three factors or domains: self-efficacy for pain control (PSE), self-efficacy for physical function (FSE), and self-efficacy for symptom control (CSE). Each belief is assessed on a Likert scale ranging from 10 to 100, reflecting the certainty regarding each item
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion10 Jul 2025 (estimated)
- Study completionDec 2025 (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 Pain (CLBP)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 273 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Federal University of Amapa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Camargo Rodrigues Iosimuta, Federal University of Amapa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627101
- Sponsor's protocol ID
- 7.010.322
- Acronym
- TMLBP
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Traditional Medicine Use in Patients With Chronic Low Back Pain in Northern Brazil: a Cross-sectional
- ClinicalTrials.gov ID
- NCT06627101
- Acronym / sponsor ID
- TMLBP / 7.010.322
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- Traditional Medicine, Beliefs, Lower back pain.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Federal University of AmapaUniversity, hospital or other
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
Chronic low back pain (CLBP) is classified as one of the leading causes of disability worldwide. Furthermore, the painful experience of CLBP can be influenced by some already established factors, such as beliefs, self-efficacy, and kinesiophobia. Beliefs are pre-established ideas that can influence physical functionality, pain experience, social functioning, and adherence to CLBP treatment Clique ou toque aqui para inserir o texto. Among them is Traditional Medicine, a practice carried out by some populations that continue to trust their own popular medicine to meet their health demands. According to the WHO, Traditional Medicine (MT) or Popular Medicine (MP) is a practice reproduced in different cultures and based on beliefs, the sum of experiences and knowledge, whose objective is to prevent, treat or cure illnesses, whether physical or mental. This habit includes the use of home remedies, which are based on the manipulation of plant, animal, and mineral extracts for therapeutic purposes. Furthermore, it is important to point out that, as it is a chronic condition, individuals living with CLBP are strongly influenced by psychological factors, such as kinesiophobia (avoidance of exercise), catastrophizing (intensifying fear of movement, as they feel that pain is a threat), and low self-efficacy in processing and modulating pain, increasing levels of pain and disability. Also, in addition to this, socioeconomic level is one of the determinants of the incidence and intensity of chronic pain. In short, although the practice of TM has been recognized for decades, it is not known whether there is a relationship between this belief and the levels of self-efficacy, kinesiophobia and catastrophizing of individuals with CLBP in Northern Brazil. Therefore, this study aims to identify the use of TM and its impacts on the functional activities and quality of life of individuals with CLBP in the northern region of Brazil. This is a cross-sectional observational study. Individuals participating in this research will be invited to respond online to the questionnaire prepared by the authors of this study. Continuous data will be analyzed descriptively using mean and standard deviation; categorical data will be described in frequency form, and the normality of the data will be analyzed to identify the possibility of using parametric or non-parametric statistical tests.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include individuals over 18 years of age, of both genders, diagnosed with chronic low back pain, who have had pain for at least three months, and who are natives of the Northern region of Brazil.
Key inclusion criteria (5 listed)
- individuals over 18 years of age
- both genders
- diagnosed with chronic low back pain
- who have had pain for at least three months
- who are natives of the Northern region of Brazil
Key exclusion criteria (4 listed)
- Individuals with low back pain of oncological origin
- recent traumas that may have caused the pain (such as falls, car accidents, and fractures)
- patients in the postoperative period
- bedridden patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of Traditional Medicine
Time frame: 1 day
a practice still relied upon by certain populations that continue to trust their own folk medicine to address their health needs
2 secondary outcomes
functionality
Time frame: 1 day
Self-Efficacy Assessment
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain (CLBP), run by Federal University of Amapa.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia CR Iosimuta, professor (1-888-463-6332, naticrod@unifap.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Traditional Medicine (time frame: 1 day). 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 8 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.