Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443229
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-05
First Post:
2024-05-14
Brief Title:
Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants Population a Randomized Controlled Trial Protocol
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to measure the effect of telerehabilitation on the treatment of nonspecific chronic LBP in the adults Brazilian Black population The main questions it aims to answer are
1 Will the graded activity exercises guided by educational approach or only the educational approach alone improve low back pain intensity functional capacity quality of life anxiety fear-avoidance beliefs due to nonspecific chronic low back pain before immediately after the 4-week intervention and after 3 and 6 months of follow-up
2 How will participants behaviors in terms of frequency and adherence exercise feedback diary and educational approach for nonspecific chronic low back pain be
What are the participants opinions and any difficulties or barriers encountered throughout the study
3 What are the perceptions of discrimination based on race gender age socioeconomic status and education when accessing healthcare services for the treatment of low back pain in the past
Researchers will compare Group Experimental Graded Activity with Educational Program with Telerehabilitation to a placebo only Educational Approach to see improve the pain intensity and functional capacity because of low back pain
Participants will
Take Group Experimental GAEP or a placebo OEA 3 times per week for 1 month
Keep a feedback diary of their symptoms and the barriers they have
Visit the researcher by online teleassessment after one month 3 months and 6 months follow-up
1 Will the graded activity exercises guided by educational approach or only the educational approach alone improve low back pain intensity functional capacity quality of life anxiety fear-avoidance beliefs due to nonspecific chronic low back pain before immediately after the 4-week intervention and after 3 and 6 months of follow-up
2 How will participants behaviors in terms of frequency and adherence exercise feedback diary and educational approach for nonspecific chronic low back pain be
What are the participants opinions and any difficulties or barriers encountered throughout the study
3 What are the perceptions of discrimination based on race gender age socioeconomic status and education when accessing healthcare services for the treatment of low back pain in the past
Researchers will compare Group Experimental Graded Activity with Educational Program with Telerehabilitation to a placebo only Educational Approach to see improve the pain intensity and functional capacity because of low back pain
Participants will
Take Group Experimental GAEP or a placebo OEA 3 times per week for 1 month
Keep a feedback diary of their symptoms and the barriers they have
Visit the researcher by online teleassessment after one month 3 months and 6 months follow-up
Detailed Description:
Background Low back pain LBP is highly prevalent ranging from 30 to 70 in developed and industrialized countries leading to health costs and work absenteeism However when it comes to the Black population studies addressing the treatment of nonspecific chronic LBP while considering the specificities of this population are scarce The use of telerehabilitation opens up opportunities for the physiotherapy community to address musculoskeletal conditions
The goal of this study is to measure the effect of telerehabilitation on the treatment of nonspecific chronic LBP in the adult Brazilian Black population
Methods A randomized controlled double-blind clinical trial with a 11 allocation of 102 Afro-Brazilian participants divided into two groups with 51 participants in each experiencing nonspecific chronic LBP for at least 3 months of both sexes aged 18-65 years residing in Brazil and divided into the Gradual Activity Group GAG and Control Group CG with a duration of 12 sessions three times per week The intervention will involve the adaptation of an exercise program protocol based on gradual activity with progressive exercise intensity through the web applications Physitrack researcher and Physiapp participant Sociodemographic and clinical characteristics will be evaluated The primary outcome will be pain intensity and secondary outcomes will include functional capacity quality of life beliefs and fears Also the perceptions of discrimination based on race gender age socioeconomic status and education will be assessed regarding prior access to healthcare services for the treatment of LBP The groups will be assessed at baseline T0 immediately post-treatment T1 at 3-months T2 and 6-months T3 follow-ups Data will be collected and managed using the REDCap electronic data capture tools
Discussion Evidence suggests that telerehabilitation can be utilized as a potential tool to promote the treatment of non-severe conditions of nonspecific chronic LBP but few studies have investigated the Black population while considering the specificities of populations that historically suffer from social inequalities in accessing healthcare treatments
The goal of this study is to measure the effect of telerehabilitation on the treatment of nonspecific chronic LBP in the adult Brazilian Black population
Methods A randomized controlled double-blind clinical trial with a 11 allocation of 102 Afro-Brazilian participants divided into two groups with 51 participants in each experiencing nonspecific chronic LBP for at least 3 months of both sexes aged 18-65 years residing in Brazil and divided into the Gradual Activity Group GAG and Control Group CG with a duration of 12 sessions three times per week The intervention will involve the adaptation of an exercise program protocol based on gradual activity with progressive exercise intensity through the web applications Physitrack researcher and Physiapp participant Sociodemographic and clinical characteristics will be evaluated The primary outcome will be pain intensity and secondary outcomes will include functional capacity quality of life beliefs and fears Also the perceptions of discrimination based on race gender age socioeconomic status and education will be assessed regarding prior access to healthcare services for the treatment of LBP The groups will be assessed at baseline T0 immediately post-treatment T1 at 3-months T2 and 6-months T3 follow-ups Data will be collected and managed using the REDCap electronic data capture tools
Discussion Evidence suggests that telerehabilitation can be utilized as a potential tool to promote the treatment of non-severe conditions of nonspecific chronic LBP but few studies have investigated the Black population while considering the specificities of populations that historically suffer from social inequalities in accessing healthcare treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None