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

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.

Conditions

• Telerehabilitation
• Low Back Pain

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Ingred Merllin B de Souza, MSc · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2024-12-22

Completion

2025-04-30

Countries

• Brazil

Study Locations