Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Br… (NCT06443229) | Clinical Trial Compass
UnknownNot Applicable
Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants
Brazil102 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity
Timeframe: The participants' pain intensity will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).