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

Instituto Politécnico de Setúbal

Status: Enrolling

Conditions: Low Back Pain

Treatments: Other: Usual Care; Other: MyBack Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05841732

PTDC/SAU-SER/7406/2020

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Usual Care

Other group

Description:

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").

Treatment:

Other: Usual Care

MyBack

Experimental group

Description:

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

Treatment:

Other: MyBack Program

Other: Usual Care