Study characteristics |
Methods |
Study design: RCT (NCT02221609)
Setting: Brazil, mixed
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 148 (E1 = 74, E2 = 74)
Chronic LBP duration: 85.05 months (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 42
Sex (female): 61% |
Interventions |
Exercise Group 1 (E1): Movement system impairment‐based classification treatment: involved patient education, analysis and modification of daily activities, and prescription of specific exercises; type = functional restoration; duration = 8 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education
Exercise Group 2 (E2): Strengthening and stretching of the core and lower limbs; type = strengthening & stretching; duration = 8 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = advice/education |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale))
Follow‐up time periods available for syntheses: 8.7 weeks (short); 26 weeks (moderate) |
Notes |
Conflicts of interest: None to declare
Funding source: Conselho Nacional de Desenvolvimento Cientifico e Tecnologico/Brazil (CNPQ grant number 470273/2013‐5); Coordenacao de Aperfeicoamento de Pessoal de Nıvel Superior
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation method entailed "generating a randomization schedule in Excel". |
Allocation concealment (selection bias) |
Low risk |
Allocations were concealed using sealed, opaque, and sequentially numbered envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviation from intended interventions because patients had no control over the delivery of intervention. |
Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Protocol and progression of exercises was provided in the appendix; one arm involved movement and alignment information which could have been provided to the other group in casual physiotherapy sessions. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain and function were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Neither treatment is obviously better than the other; no reason to alter patient response. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Loss to follow‐up at each time point was only 2% (3/148). |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Intention‐to‐treat analysis was conducted. |
Selective reporting (reporting bias) |
Low risk |
1. Study was analysed and reported according to registered protocol (NCT02221609). |
Groups similar at baseline (selection bias) |
Low risk |
Groups were similar on all relevant characteristics at baseline. |
Co‐interventions avoided or similar (performance bias) |
High risk |
No information on co‐interventions reported in this study |
Compliance acceptable in all groups (performance bias) |
High risk |
Mean adherence was 67% and 49.3% in the comparator and experimental intervention, respectively. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Numeric Rating Scale (for pain) and Roland‐Morris Disability Questionnaire (for function) are well‐validated tools in the low back pain context. |
Other bias |
Low risk |
No other sources of bias noticed; generally well‐reported |