Clinical Trials in Portugal / NCT05841732
Recruiting
Not applicable
MyBack - A Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences
NCT05841732 · tracked via the Priya Life Science Portugal tracker
Condition(s) studied
Low Back Pain
Investigational drug(s) / intervention(s)
Usual CareMyBack Program
Usual Care: Education; Pain Medication, imaging, referrals to other health services, other health care appointments
MyBack Program: A tailored exercise and behavioural change program
Study 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
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 outcome measure(s)
- Risk of low back pain recurrence — 1 month 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. - Risk of low back pain recurrence — 2 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. - Risk of low back pain recurrence — 3 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. - Risk of low back pain recurrence — 4 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. - Risk of low back pain recurrence — 5 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. - Risk of low back pain recurrence — 6 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. - Risk of low back pain recurrence — 7 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. - Risk of low back pain recurrence — 8 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. - Risk of low back pain recurrence — 9 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. - Risk of low back pain recurrence — 10 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. - Risk of low back pain recurrence — 11 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. - Risk of low back pain recurrence — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Instituto Politécnico de Setúbal | Setúbal | Setúbal District | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05841732 on ClinicalTrials.gov ↗ ← All trials in Portugal