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Recruiting NCT05841732

MyBack - A Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual Care, MyBack Program.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Usual Care
    Education; Pain Medication, imaging, referrals to other health services, other health care appointments
  • Other MyBack Program
    A tailored exercise and behavioural change program

Primary outcome measures

  • Risk of low back pain recurrence [Time frame: 1 month after baseline]
  • Risk of low back pain recurrence [Time frame: 2 months after baseline]
  • Risk of low back pain recurrence [Time frame: 3 months after baseline]
  • Risk of low back pain recurrence [Time frame: 4 months after baseline]
  • Risk of low back pain recurrence [Time frame: 5 months after baseline]
  • Risk of low back pain recurrence [Time frame: 6 months after baseline]
  • Risk of low back pain recurrence [Time frame: 7 months after baseline]
  • Risk of low back pain recurrence [Time frame: 8 months after baseline]
  • Risk of low back pain recurrence [Time frame: 9 months after baseline]
  • Risk of low back pain recurrence [Time frame: 10 months after baseline]
Secondary outcome measures (12)
  • Pain intensity [Time frame: Baseline, 3, 6 and 12 months after baseline]
  • Functional Disability [Time frame: Baseline, 3, 6 and 12 months after baseline]
  • Musculoskeletal Health [Time frame: Baseline, 3, 6 and 12 months after baseline]
  • Health-related quality of life [Time frame: Baseline, 3, 6 and 12 months after baseline]
  • Medical appointments for a low back pain recurrence [Time frame: 3, 6, 9 and 12 months after baseline]
  • Imaging tests prescribed related with a low back pain recurrence [Time frame: 3, 6, 9 and 12 months after baseline]
  • Pain medication for low back pain recurrence [Time frame: 3, 6, 9 and 12 months after baseline]
  • Referral to other interventions and sickness certificates [Time frame: 3, 6, 9 and 12 months after baseline]
  • Impact of LBP recurrence [Time frame: 1 month after baseline]
  • Impact of LBP recurrence [Time frame: 2 months after baseline]
  • Impact of LBP recurrence [Time frame: 3 months after baseline]
  • Impact of LBP recurrence [Time frame: 4 months after baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • Instituto Politécnico de Setúbal — Setúbal

Publications

  • Pires D, Duarte S, Rodrigues AM, Caeiro C, Canhao H, Branco J, Alves J, Marques M, Aguiar P, Fernandes R, Sousa RD, Cruz EB. MyBack - effectiveness and implementation of a behavior change informed exercise programme to prevent low back pain recurrences: a hybrid effectiveness-implementation randomized controlled study protocol. BMC Musculoskelet Disord. 2024 Jun 5;25(1):440. doi: 10.1186/s12891-02 PMID 38840084

Identifiers

NCT: NCT05841732 · PTDC/SAU-SER/7406/2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗