Low Back Pain
Conditions
Keywords
Low back pain, Recurrences, Exercise, Behaviour change, Primary health care
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.
Interventions
OTHERUsual Care
Education; Pain Medication, imaging, referrals to other health services, other health care appointments
OTHERMyBack Program
A tailored exercise and behavioural change program
Sponsors
Universidade Nova de Lisboa
Instituto Politécnico de Setúbal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of low back pain recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability | 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. |
| Musculoskeletal Health | 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. |
| Health-related quality of life | 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. |
| Medical appointments for a low back pain recurrence | 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 |
| Pain intensity | 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. |
| Pain medication for low back pain recurrence | 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 |
| Referral to other interventions and sickness certificates | 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. |
| Impact of LBP recurrence | 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. |
| Imaging tests prescribed related with a low back pain recurrence | 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 |
Countries
Portugal
Contacts
Primary ContactEduardo Cruz, PhD
Outcome results
None listed