NCT06627101

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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

September 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

October 26, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

September 26, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

Traditional MedicineBeliefsLower back pain.

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Secondary Outcomes (2)

  • functionality

    1 day

  • Self-Efficacy Assessment

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Natalia CR Iosimuta, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 4, 2024

Study Start

October 26, 2024

Primary Completion

July 10, 2025

Study Completion

December 1, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share