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

N/AEnrolling By InvitationNCT06443229

University of Sao Paulo General Hospital102 enrolled

Overview

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.

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.

Interventions

Graded Activity based in exercises and educational approachBEHAVIORAL

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 ApproachOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain intensity

Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). It is an 11-point scale ranging from 0 to 10, with zero indicating no pain and 10 indicating the most unbearable pain experienced by the participant. The subject will be asked about the presence of pain specifically localized to the lumbar region. Additionally, the frequency (every day, more than 15 days per month, between 8 and 15 days per month, between 1 and 7 days per month, or between 4 and 11 crises per year) and duration of symptoms (less than 2 years, 2 to 5 years, 6 to 10 years, more than 10 years) will be queried. The following definition of LBP will be utilized: "pain in the area between the 12th rib and the gluteal fold with or without leg pain.

Time frame: The participants' pain intensity will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).

Secondary Outcomes

Functional disability

The Roland-Morris Disability Questionnaire (RMDQ) will be used. This questionnaire assesses the impact of low back pain on work and daily life activities due to symptoms, and it is better recommended for a population with low functional disability. The instrument has been validated for Brazilian Portuguese, is quick and easy to administer, with an average response time of five minutes. Scores are obtained by summing the items, which range from zero (no disability) to 24 (severe disability). Scores higher than 14 indicate physical disability. The minimum clinically important difference is 5 points.

Time frame: The participants' functional disability will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).

Quality of life Impact

To assess quality of life, the 12-Item Short-Form Health Survey (SF-12) will be used as a quicker alternative to the 36-Item Health Survey. Comprising twelve items derived from the SF-36, the SF-12 assesses eight different dimensions influencing quality of life, considering the individual's perception of their health over the past four weeks. Each item has a set of responses distributed on a Likert-type scale, evaluating the following dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Through the instrument's own algorithm, two scores can be measured: the physical component summary (PCS) and the mental component summary (MCS). In both, scores range from 0 to 100 points, with higher scores associated with better quality of life. Psychometric properties of the instrument have also been evaluated.

Time frame: The participants' quality of life will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).

State-Trait Anxiety

For anxiety assessment, the State-Trait Anxiety Inventory (STAI) will be used, which has been translated and adapted for use in Brazil. The scale consists of 2 self-report scales that assess state and trait anxiety. The scale comprises 20 items scored from 1 to 4 each, resulting in a total score ranging from 20 to 80 points. For each question, the corresponding score is assigned, but for positively framed questions, the score is reversed. Scores \> 42 tend to indicate anxiety, while scores \< 38 tend to indicate depression. The STAI Manual suggests using the title "Self-Assessment Questionnaire" instead of the term Anxiety.

Time frame: The participants' State-Trait Anxiety will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).

Fear Avoidance Beliefs

The Fear Avoidance Beliefs Questionnaire (FABQ), translated into Brazilian Portuguese, contains two sub-scales that are evaluated separately: fear-avoidance beliefs related to work (FABQ-work) and physical activity (FABQ-physical). Fear avoidance related to physical activity will be considered present (score ≥15) or absent (\<15), while fear avoidance related to work will be considered present if the FABQ-work score is ≥ 34.

Time frame: The participants' fear avoidance beliefs will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).