MyBack

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Participants allocated to the usual care group will be informed that they can access their GP in the usual way (GPs consultation, pain medication, referral for other treatments/ services) and that they should contact their GP if their condition worsens. In addition, they will receive a minimal educational intervention focused on symptom management and promotion of physical activity ("stay active").

Group Type OTHER

Usual Care

Intervention Type OTHER

Education; Pain Medication, imaging, referrals to other health services, other health care appointments

Patients in the MyBack group will participate in a patient-centred, tailored exercise programme informed by a behavioural change approach in addition to receiving usual care. The MyBack intervention programme will consist of 12 bi-weekly sessions (60 minutes each) over 6 weeks complemented by 12 exercise sessions to be carried out autonomously by the participants over the following 6 weeks

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

Education; Pain Medication, imaging, referrals to other health services, other health care appointments

MyBack Program

Intervention Type OTHER

A tailored exercise and behavioural change program

Interventions

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Usual Care

Education; Pain Medication, imaging, referrals to other health services, other health care appointments

Intervention Type OTHER

MyBack Program

A tailored exercise and behavioural change program

Intervention Type OTHER

Other Intervention Names

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Minimal intervention Physiotherapy

Eligibility Criteria

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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.