A program to prevent low back pain recurrences through exercise and behavior change
MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study
This study tests if a new exercise and behavior change program can help people with low back pain avoid future episodes better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Instituto Politécnico de Setúbal Academic / other |
| Locations | 1 site (Setúbal, Setúbal District) |
| Trial ID | NCT05841732 on ClinicalTrials.gov |
What this trial studies
The MyBack program aims to prevent recurrences of low back pain by implementing a tailored exercise and behavioral change intervention. This multicenter, randomized controlled trial will evaluate the effectiveness of the MyBack program compared to usual care in primary health care settings. The study will also assess the acceptability, feasibility, and implementation strategies of the program among various stakeholders. Participants will be monitored for their recovery from low back pain and their engagement with the program over time.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 who have recently recovered from an episode of non-specific low back pain and can communicate in Portuguese.
Not a fit: Patients with severe psychiatric conditions, recent spinal surgery, or those who are pregnant may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce the recurrence of low back pain, improving patients' quality of life and reducing healthcare costs.
How similar studies have performed: Other studies have shown promise in using exercise and behavioral change strategies for managing low back pain, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Setúbal, Setúbal District
- Instituto Politécnico de Setúbal — Setúbal, Setúbal District, Portugal (Recruiting)
Study contacts
- Principal investigator: Eduardo Cruz, PhD — Instituto Politécnico de Setúbal
- Study coordinator: Eduardo Cruz, PhD
- Email: eduardo.cruz@ess.ips.pt
- Phone: +365 265 709 300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.