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

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto Politécnico de Setúbal

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,

Pregnancy

Spinal surgery in the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual Care

    Other intervention

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

  • MyBack Program

    Other intervention

    A tailored exercise and behavioural change program

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Usual CareOther 1 intervention
Group B: MyBackExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month after baseline
2

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.

Time frame
2 months after baseline
3

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.

Time frame
3 months after baseline
4

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.

Time frame
4 months after baseline

Secondary outcomes

1

Pain intensity

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.

Time frame
Baseline, 3, 6 and 12 months after baseline
2

Functional Disability

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.

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

Musculoskeletal Health

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.

Time frame
Baseline, 3, 6 and 12 months after baseline
4

Health-related quality of life

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Politécnico de Setúbal

Lead sponsor

Universidade Nova de Lisboa

Collaborator