About this trial
Low Back Pain is a common heath condition with high rates of recurrence and huge associated costs. Research has focused its efforts on analysing the effects of interventions while knowledge about effective secondary prevention strategies is limited. MyBack study aims to analyse the effectiveness of a tailored exercise and behavioural change program (MyBack program) in the secondary prevention of low back pain, and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack program, through a hybrid type I, randomized, controlled and multicentre study of effectiveness and implementation in the context of primary health care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Recovered (within the last 3 months) from an episode of non-specific LBP (with or without leg pain and of any duration)
Recovery from an LBP episode is defined as having a pain score of "0" or "1" on a 11-point Numeric Pain Rating Scale for, at least, 30 consecutive days
Age between 18 and 65 years;
Read and speak the Portuguese language;
Disqualifiers
Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
Pregnancy
Spinal surgery in the last 6 months
Trial design
Parallel
Treatments tested in this trial
Usual Care
Other interventionEducation; Pain Medication, imaging, referrals to other health services, other health care appointments
MyBack Program
Other interventionA tailored exercise and behavioural change program
Treatment groups
Trial outcomes
Primary outcomes
Risk of low back pain recurrence
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Risk of low back pain recurrence
Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.
Secondary outcomes
Pain intensity
Pain intensity will be measured with a 11-point Numeric Pain Rating Scale. Total scores range from 0 to 10, with higher scores indicating higher levels of pain.
Functional Disability
Functional Disability will be measured through the Roland Morris Disability Questionnaire (RMDQ). Total scores range from 0 to 24, with higher scores indicating higher levels of functional disability.
Musculoskeletal Health
Musculoskeletal Health will be measured through the Musculoskeletal Health Questionnaire (MSK-HQ). Total scores range from 0 to 56, with higher scores indicating higher levels of musculoskeletal health.
Health-related quality of life
Health-related Quality of life (HRQoL) will be measured by the EuroQuol 5 dimensions, 5 levels questionnaire. Total scores range from 0 to 1, with higher scores indicating higher levels of health-related quality of life.
Sponsors and contacts
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Instituto Politécnico de Setúbal
Lead sponsor
Universidade Nova de Lisboa
Collaborator