Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants

NCT ID: NCT06443229

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-04-30

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.

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 1:1 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.

Conditions

Telerehabilitation; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Graded Activity based in exercises and educational approach

Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform.

Group Type: EXPERIMENTAL

Graded Activity based in exercises and educational approach

Intervention Type: BEHAVIORAL

Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform. Participants will be randomized into two groups: the Experimental Group (EG), which will receive graded activity along with the educational approach, three times a week, over 12 sessions, totaling 4 weeks.

The intervention will involve adapting a protocol from an exercise program based on gradual activity with progressively increasing exercise intensity using web applications from Physitrack® Ltd., LDN, United Kingdom (used by the physiotherapist/researcher) and Physiapp® (used by the participant). Participants will be provided with (i) a welcome letter outlining the intervention/group components they are allocated to; (ii) instructions on how to use the Physiapp® web application (web browser, Android or iOS app) at home.

Educational Approach

Educational approach for low back pain using Telerehabilitation platform.

Group Type: SHAM_COMPARATOR

Educational Approach

Intervention Type: OTHER

Educational approach for low back pain using Telerehabilitation platform. Participants will receive educational materials with an isolated educational approach, with the delivery of the materials occurring three times a week.

Interventions

Graded Activity based in exercises and educational approach

Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform. Participants will be randomized into two groups: the Experimental Group (EG), which will receive graded activity along with the educational approach, three times a week, over 12 sessions, totaling 4 weeks.

The intervention will involve adapting a protocol from an exercise program based on gradual activity with progressively increasing exercise intensity using web applications from Physitrack® Ltd., LDN, United Kingdom (used by the physiotherapist/researcher) and Physiapp® (used by the participant). Participants will be provided with (i) a welcome letter outlining the intervention/group components they are allocated to; (ii) instructions on how to use the Physiapp® web application (web browser, Android or iOS app) at home.

Intervention Type: BEHAVIORAL

Educational Approach

Educational approach for low back pain using Telerehabilitation platform. Participants will receive educational materials with an isolated educational approach, with the delivery of the materials occurring three times a week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Self-identify as Black (Black or Brown), according to Brazilian Institute of Geography and Statistics (IBGE) classification;
• Age range from 18 to 65 years old;
• Both biological sexes (female and male);
• Sedentary or physically active participants;
• Present chronic low back pain with a score ≥ 3 on the Numeric Pain Rating Scale for more than 3 months and due to nonspecific causes;
• Able to read, write, and speak Brazilian Portuguese;
• Live in Brazil in urban or rural areas;
• Have access to the internet;
• Possess a device with internet access with a screen, camera, microphone, and speaker (smartphone, tablet, or computer); and
• Have a reasonable self-assessment ability to use the internet (through a 4-item scale from poor, fair, good to excellent).

Exclusion Criteria

• History of traumatic injury.
• Previous surgery related to the lumbar spine.
• Undergoing cancer treatment.
• Presenting with any inflammatory rheumatological condition.
• Decompensated cardiovascular disorders.
• Presence of comorbidity or condition that may hinder active participation in the prescribed exercises to be performed at home.
• Severe psychological disorders.
• Pregnant individuals.
• Awaiting surgical procedure.
• Having undergone intervention including exercise or physiotherapeutic treatment in the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingred Merllin B de Souza, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Dept. Physical Therapy, Audiology and Speech Therapy at Medical School, University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5.991.168

Identifier Type: -

Identifier Source: org_study_id