Study characteristics |
Methods |
Study design: RCT (ACTRN12610000435088)
Setting: Brazil, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 148 (E1 = 74, E2 = 74)
Chronic LBP duration: 22.5 months (moderate)
Neurological/radicular symptoms: Not specified
Mean age (years): 54
Sex (female): 73% |
Interventions |
Exercise Group 1 (E1): Progressive McKenzie exercises after individual assessment, home exercises; type = McKenzie; duration = 4 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = advice/education
Exercise Group 2 (E2): Breathing exercises, kinaesthetic training, stretching of lower back, quadriceps, and hamstring muscles, abdominal strengthening exercises, home exercises; type = mixed; duration = 4 weeks; dose = low; design = standardised; delivery = group; additional intervention = back school |
Outcomes |
Core outcomes reported: Pain (Numeric Rating Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (World Health Organization Quality of Life–BREF [WHOQOL‐BREF])
Follow‐up time periods available for syntheses: 4 weeks (short); 12 weeks (short); 26 weeks (moderate) |
Notes |
Conflicts of interest: Not reported
Funding source: Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Support for judgement was not available. |
Allocation concealment (selection bias) |
Low risk |
The allocation was concealed by using consecutively numbered, sealed, opaque envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Given the nature of the interventions, it was not possible for the therapist or the patients to be blinded. |
Blinding of care provider (performance bias) |
High risk |
Given the nature of the interventions, it was not possible for the therapist or the patients to be blinded. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Given the nature of the interventions, it was not possible for the therapist or the patients to be blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Refer to flow chart |
Participants analysed in group allocated (attrition bias) |
Low risk |
Support for judgement was not available. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
The baseline characteristics of both groups were similar. |
Co‐interventions avoided or similar (performance bias) |
Unclear risk |
Not described |
Compliance acceptable in all groups (performance bias) |
Low risk |
Back School group attended a mean of 3.64 sessions (SD 0.08); this was 3.72 sessions (SD 0.06) for participants allocated to the McKenzie group. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |