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

NCT05841732 | Recruiting

• 1 other identifier: PTDC/SAU-SER/7406/2020
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Low back pain; Recurrences; Exercise; Behaviour change; Primary health care

Outcome Measures

Primary Outcomes (12)

• Risk of low back pain recurrence

  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.

  1 month after baseline

• Risk of low back pain recurrence

  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.

  2 months after baseline

• Risk of low back pain recurrence

  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.

  3 months after baseline

• Risk of low back pain recurrence

  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.

  4 months after baseline

• Risk of low back pain recurrence

  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.

  5 months after baseline

• Risk of low back pain recurrence

  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.

  6 months after baseline

• Risk of low back pain recurrence

  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.

  7 months after baseline

• Risk of low back pain recurrence

  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.

  8 months after baseline

• Risk of low back pain recurrence

  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.

  9 months after baseline

• Risk of low back pain recurrence

  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.

  10 months after baseline

• Risk of low back pain recurrence

  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.

  11 months after baseline

• Risk of low back pain recurrence

  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.

  12 months after baseline

Secondary Outcomes (20)

• Pain intensity

  Baseline, 3, 6 and 12 months after baseline

• Functional Disability

  Baseline, 3, 6 and 12 months after baseline

• Musculoskeletal Health

  Baseline, 3, 6 and 12 months after baseline

• Health-related quality of life

  Baseline, 3, 6 and 12 months after baseline

• Medical appointments for a low back pain recurrence

  3, 6, 9 and 12 months after baseline

Study Arms (2)

Usual Care

OTHER

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").

Other: Usual Care

MyBack

EXPERIMENTAL

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

Other: Usual Care; Other: MyBack Program

Interventions

Usual Care OTHER

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

Also known as: Minimal intervention

MyBack; Usual Care

MyBack Program OTHER

A tailored exercise and behavioural change program

Also known as: Physiotherapy

MyBack

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
• Pregnancy
• Spinal surgery in the last 6 months

Sponsors & Collaborators

• Instituto Politécnico de Setúbal: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Instituto Politécnico de Setúbal

Setúbal, Setúbal District, 2914-503, Portugal

RECRUITING

Related Publications (1)

• 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/s12891-024-07542-7.

  PMID: 38840084 DERIVED

MeSH Terms

Conditions

Low Back Pain; Recurrence; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Eduardo Cruz, PhD

  Instituto Politécnico de Setúbal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Cruz, PhD

CONTACT

+365 265 709 300; eduardo.cruz@ess.ips.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: April 10, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)