TelerehabilitationNCT06443229
Effect of Telerehabilitation Use in the Treatment of Non-specific Chronic Low Back Pain in the Brazilian Afrodescendants
A study testing Graded Activity based in exercises and educational approach and Educational Approach in people with Telerehabilitation and Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Telerehabilitation, Low Back Pain
- What is being tested?
- Graded Activity based in exercises and educational approach and Educational Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- Severe psychological disorders.
- Pregnant individuals.
- Awaiting surgical procedure.
- Having undergone intervention including exercise or physiotherapeutic treatment in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dept. Physical Therapy, Audiology and Speech Therapy at Medical School, University of Sao Paulo
São Paulo, 05360-000
About this study
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
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:
- 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?
- 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?
- 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?
Read more
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.
Read the 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
- Being tested
- Graded Activity based in exercises and educational approach, Educational Approach
- Keywords
- Telerehabilitation, Low Back Pain, Black People, Pain, Disability, Rehabilitation, Health of Ethnic Minorities
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Activity based in exercises and educational approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Graded Activity based in exercises and educational approach | Experimental | Exercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform. Receives: Behavioral: Graded Activity based in exercises and educational approach |
| Educational Approach | Sham comparator | Educational approach for low back pain using Telerehabilitation platform. Receives: Other: Educational Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The participants' fear avoidance beliefs will be evaluated at baseline (T0), after 12 sessions (T1), at 3 months (T2), and at 6 months (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Oct 2023
- Primary completion22 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled double-blind clinical trial, with a 1:1 allocation of 102 participants divided into two groups (intervention or control).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingred Merllin B de Souza, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443229
- Sponsor's protocol ID
- 5.991.168
- Status last verified
- Mar 2024
- First submitted
- 14 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batista de Souza IM, Vidali JR, Macena RG, Jorge IS, Williams DR, Marques AP. Effect of telerehabilitation on the treatment of chronic nonspecific low back pain in the Afro-Brazilian population: a randomized controlled trial protocol. Trials. 2026 Mar 16;27(1):316. doi: 10.1186/s13063-026-09433-9.
PubMed 41840701
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06443229
- Acronym / sponsor ID
- 5.991.168
- Conditions
- Telerehabilitation, Low Back Pain
- Keywords
- Telerehabilitation, Low Back Pain, Black People, Pain, Disability, Rehabilitation, Health of Ethnic Minorities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled double-blind clinical trial, with a 1:1 allocation of 102 participants divided into two groups (intervention or control).
| Arm | Type | Receives |
|---|---|---|
| Graded Activity based in exercises and educational approach | Experimental | Behavioral: Graded Activity based in exercises and educational approachExercises for warming up, strengthening, and relaxation, along with informational sessions incorporating an educational approach for low back pain using Telerehabilitation platform. |
| Educational Approach | Sham comparator | Other: Educational ApproachEducational approach for low back pain using Telerehabilitation platform. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- History of traumatic injury.
- Previous surgery related to the lumbar spine.
- Undergoing cancer treatment.
- Presenting with any inflammatory rheumatological condition.
- Decompensated cardiovascular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Activity based in exercises and educational approachExercises 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. | Behavioural | Graded Activity based in exercises and educational approach |
| Educational ApproachEducational 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. | Other | Educational Approach |
Primary outcome
Pain intensity
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).
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.
4 secondary outcomes
Functional disability
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
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
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 41840701Batista de Souza IM, Vidali JR, Macena RG, Jorge IS, Williams DR, Marques AP. Effect of telerehabilitation on the treatment of chronic nonspecific low back pain in the Afro-Brazilian population: a randomized controlled trial protocol. Trials. 2026 Mar 16;27(1):316. doi: 10.1186/s13063-026-09433-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingred Merllin B de Souza, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Activity based in exercises and educational approach and Educational Approach in people with Telerehabilitation and Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.