Low Back Pain
Conditions
Interventions
This study protocol describes the design of a non-inferiority randomized controlled trial, parallel, two-arm with an economic evaluation and a 1:1 allocation ratio. The study will have 80 participants
Sponsors
Departamento de Fisioterapia da Universidade Federal de São Carlos
Departamento de Fisioterapia da Universidade Federal de São Carlos
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; between 18 and 65 years old; with non-specific low back pain lasting three months or longer; a score greater than or equal to 3 on the Numerical Rating Scale (NRS); a score > 14% on the Oswestry Disability Index (ODI); be able to speak and understand Portuguese; and have access to a smartphone, tablet, or computer with internet connectivity
Exclusion criteria
Exclusion criteria: Pregnancy; presence of tumors, infections, or metastases; specific causes of chronic low back pain such as radiculopathy, lumbar stenosis, or chronic degenerative disorders; history of fracture or recent orthopedic surgery (in the last 12 months); surgery scheduled for the next 6 months; heart disease, neurological or rheumatic disorders, as well as any medical contraindication to physical activity; score less than 2 on the Mini-Cog; uncorrected hearing and visual impairments; or any health condition that prevents the safe and adequate performance of exercises
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess average pain intensity over the past 7 days using the 11-point numerical rating scale (NRS). Pain intensity change scores will be calculated at baseline, and at 3, 6, and 9 months after randomization;To assess average exercise adherence using the Exercise Adherence Rating Scale (EARS-Br). Changes in adherence will be calculated at week 2 of the intervention, end of treatment (3 months), and 6- and 9-month follow-ups | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess function using the Oswestry Disability Index (ODI) at baseline, and at 3, 6, and 9 months after randomization;To assess the overall perception of change at the end of the intervention (3 months) using the 11-point Global Perceived Effect (GPE) Scale ;To assess the level of satisfaction at the end of the intervention (3 months) using the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS);To assess pain self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ-10) at baseline, and at 3, 6, and 9 months after randomization;To assess the therapeutic alliance at the end of the intervention (3 months) using the Working Alliance Inventory – Patient (WAI-RS);To assess attendance at appointments through records kept by physiotherapists in treatment notes and by participants in Exercise and Appointment Log;To assess health-related quality of life using the EQ-5D-3L questionnaire at baseline and at 3, 6, and 9 months after randomization;To assess the occurrence of adverse events during treatment and 3 months after randomization, by recording the quantity and type of event reported by participants. Any problem experienced in the back or any other part of the body that the participant considers to be a result of the exercise and/or the guidance provided by the physiotherapist will be considered an adverse event;To assess cost-effectiveness using pain intensity 9 months after randomization and cost-utility using quality-adjusted life years (QALYs). The QALY will be calculated using linear interpolation between the utilities measured at baseline, 3, 6, and 9 months after randomization | — |
Countries
Brazil
Contacts
Public ContactCamila Broisler
Universidade Federal de São Carlos
Outcome results
None listed