MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Instituto Politécnico de Setúbal
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Risk of low back pain recurrence
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eduardo B. Cruz
Professor
Instituto Politécnico de Setúbal
Eligibility Criteria
Inclusion Criteria
- •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;
- •Having a mobile phone capable of receiving and sending text messages;
- •No medical contraindication to exercise.
Exclusion Criteria
- •Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
- •Pregnancy
- •Spinal surgery in the last 6 months
Outcomes
Primary Outcomes
Risk of low back pain recurrence
Time Frame: 12 months after baseline
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(Baseline, 3, 6 and 12 months after baseline)
- Functional Disability(Baseline, 3, 6 and 12 months after baseline)
- Musculoskeletal Health(Baseline, 3, 6 and 12 months after baseline)
- Health-related quality of life(Baseline, 3, 6 and 12 months after baseline)
- Medical appointments for a low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Imaging tests prescribed related with a low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Pain medication for low back pain recurrence(3, 6, 9 and 12 months after baseline)
- Referral to other interventions and sickness certificates(3, 6, 9 and 12 months after baseline)
- Impact of LBP recurrence(12 months after baseline)