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NCT Number: NCT05841732

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

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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Key information

Conditions

Low Back Pain Back Pain Behavior Disease Attributes Motor Activity Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Politécnico de Setúbal

Setúbal, Setúbal District, 2914-503, Portugal

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

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

Other names: Minimal intervention

MyBack Program

Other

A tailored exercise and behavioural change program

Other names: Physiotherapy

Primary outcomes

  1. Risk of low back pain recurrence

    Time frame: 1 month after baseline

    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. Risk of low back pain recurrence

    Time frame: 2 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 3 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 4 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 5 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 6 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 7 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 8 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 9 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 10 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 11 months after baseline

    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. Risk of low back pain recurrence

    Time frame: 12 months after baseline

    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.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline, 3, 6 and 12 months after baseline

    Pain intensity will be measured with a 11-point Numeric Pain Rating Scale. Total scores range from 0 to 10, with higher scores indicating higher levels of pain.

  2. Functional Disability

    Time frame: Baseline, 3, 6 and 12 months after baseline

    Functional Disability will be measured through the Roland Morris Disability Questionnaire (RMDQ). Total scores range from 0 to 24, with higher scores indicating higher levels of functional disability.

  3. Musculoskeletal Health

    Time frame: Baseline, 3, 6 and 12 months after baseline

    Musculoskeletal Health will be measured through the Musculoskeletal Health Questionnaire (MSK-HQ). Total scores range from 0 to 56, with higher scores indicating higher levels of musculoskeletal health.

  4. Health-related quality of life

    Time frame: Baseline, 3, 6 and 12 months after baseline

    Health-related Quality of life (HRQoL) will be measured by the EuroQuol 5 dimensions, 5 levels questionnaire. Total scores range from 0 to 1, with higher scores indicating higher levels of health-related quality of life.

  5. Medical appointments for a low back pain recurrence

    Time frame: 3, 6, 9 and 12 months after baseline

    The number of primary care visits to the General Practitioner for a low back pain recurrence, for each participant, will be collected from the local medical records

  6. Imaging tests prescribed related with a low back pain recurrence

    Time frame: 3, 6, 9 and 12 months after baseline

    The number of x-rays, MRI and CT-scans of lower back will be collected for each participant from the local medical records

  7. Pain medication for low back pain recurrence

    Time frame: 3, 6, 9 and 12 months after baseline

    The number and name of the medication prescribed will be collected for each participant from the local medical records

  8. Referral to other interventions and sickness certificates

    Time frame: 3, 6, 9 and 12 months after baseline

    Referral to other interventions or to other medical specialities or services or sickness certificates will be recorded will be collected for each participant from the local medical records.

  9. Impact of LBP recurrence

    Time frame: 1 month after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  10. Impact of LBP recurrence

    Time frame: 2 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  11. Impact of LBP recurrence

    Time frame: 3 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  12. Impact of LBP recurrence

    Time frame: 4 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  13. Impact of LBP recurrence

    Time frame: 5 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  14. Impact of LBP recurrence

    Time frame: 6 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  15. Impact of LBP recurrence

    Time frame: 7 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  16. Impact of LBP recurrence

    Time frame: 8 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  17. Impact of LBP recurrence

    Time frame: 9 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  18. Impact of LBP recurrence

    Time frame: 10 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  19. Impact of LBP recurrence

    Time frame: 11 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

  20. Impact of LBP recurrence

    Time frame: 12 months after baseline

    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. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Cruz, PhD

CONTACT

[email protected]

+365 265 709 300

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Setúbal

Other

Collaborators

  • Universidade Nova de Lisboa

Registry information

Official study 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

Acronym: MyBack

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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