Clinical trial NCT05841732: MyBack - A Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences
Official title: MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Recurrences
Exercise
Behaviour change
Primary health care
Lead sponsor: Instituto Politécnico de Setúbal
Sponsor class: OTHER
Collaborators: name: Universidade Nova de Lisboa
First posted: 2023-05-03
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Risk of low back pain recurrence
timeFrame: 1 month after baseline
measure: Risk of low back pain recurrence
timeFrame: 2 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 3 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 4 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 5 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 6 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 7 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 8 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 9 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 10 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 11 months after baseline
measure: Risk of low back pain recurrence
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline, 3, 6 and 12 months after baseline
measure: Functional Disability
timeFrame: Baseline, 3, 6 and 12 months after baseline
measure: Musculoskeletal Health
timeFrame: Baseline, 3, 6 and 12 months after baseline
measure: Health-related quality of life
timeFrame: Baseline, 3, 6 and 12 months after baseline
measure: Medical appointments for a low back pain recurrence
timeFrame: 3, 6, 9 and 12 months after baseline
measure: Imaging tests prescribed related with a low back pain recurrence
timeFrame: 3, 6, 9 and 12 months after baseline
measure: Pain medication for low back pain recurrence
timeFrame: 3, 6, 9 and 12 months after baseline
measure: Referral to other interventions and sickness certificates
timeFrame: 3, 6, 9 and 12 months after baseline
measure: Impact of LBP recurrence
timeFrame: 1 month after baseline
measure: Impact of LBP recurrence
timeFrame: 2 months after baseline
measure: Impact of LBP recurrence
timeFrame: 3 months after baseline
measure: Impact of LBP recurrence
timeFrame: 4 months after baseline
measure: Impact of LBP recurrence
timeFrame: 5 months after baseline
measure: Impact of LBP recurrence
timeFrame: 6 months after baseline
measure: Impact of LBP recurrence
timeFrame: 7 months after baseline
measure: Impact of LBP recurrence
timeFrame: 8 months after baseline
measure: Impact of LBP recurrence
timeFrame: 9 months after baseline
measure: Impact of LBP recurrence
timeFrame: 10 months after baseline
measure: Impact of LBP recurrence
timeFrame: 11 months after baseline
measure: Impact of LBP recurrence
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Setúbal
country: Portugal
facility: Instituto Politécnico de Setúbal
Study officials:
affiliation: Instituto Politécnico de Setúbal
name: Eduardo Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References: