Study characteristics |
Methods |
Study design: RCT
Setting: Iran, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 41 (E1 = 20, E2 = 21)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 37
Sex (female): Not reported |
Interventions |
Exercise Group 1 (E1): Stabilisation exercises plus routine physiotherapy consisting of electrotherapy and warm‐up exercises which were all stretches; type = core strengthening; duration = 4 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = electrotherapy
Exercise Group 2 (E2): "Routine" exercises: images portray 16 different poses; type = core strengthening; duration = 4 weeks; dose = not reported; design = standardised; delivery = individual; additional intervention = electrotherapy |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale)
Follow‐up time periods available for syntheses: 4 weeks (short) |
Notes |
Conflicts of interest: None to declare
Funding source: University of Social Welfare and Rehabilitation Sciences
Other: SDs imputed |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Block‐style randomisation used |
Allocation concealment (selection bias) |
High risk |
No information reported on concealment of treatment allocation |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Treatments were so similar; doubtful that someone would have known if he/she was in the treatment or comparison groups |
Blinding of care provider (performance bias) |
High risk |
1. Physical therapist delivered treatments to both groups, so he/she would have known which group someone was in; 2. Possible that the lack of physiotherapist blinding could have led patients with severe symptoms in the routine treatment group to receive more care at the physiotherapist's discretion; 3. Unlikely that deviations from intended intervention due to lack of physiotherapist blinding were balanced between groups, as routine care group could be perceived to receive less/inadequate care and need more; 4. If the lack of physiotherapist blinding caused patients in routine care to receive better care than expected, then we would expect smaller differences in outcomes between interventions; we did observe this. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain intensity were patients themselves, who could not be blinded due to the nature of the interventions; 2. If patients perceived one intervention as better than the other, then their lack of blinding may have led patients in the "worse" intervention to feel that they had "worse" outcomes; 3. If lack of patient blinding caused bias toward "worse" outcome assessment, we would expect a greater difference in outcomes between intervention groups; we observed no significant group differences. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate was zero, as all patients who were randomised completed the trial. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. No dropouts from baseline, so they were just analysed in the groups they were treated in. |
Selective reporting (reporting bias) |
Low risk |
1. No linked protocol but within the article there were no obvious omissions. Pain reported and biomechanical function reported |
Groups similar at baseline (selection bias) |
Low risk |
No significant differences between the intervention groups on age, pain intensity or body mass index at baseline; neither sex nor duration of symptoms were reported. |
Co‐interventions avoided or similar (performance bias) |
High risk |
No report on whether co‐interventions were controlled in this study |
Compliance acceptable in all groups (performance bias) |
High risk |
Compliance not assessed |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcomes assessed at same time of day, blinded assessors used across all groups; 2. Visual Analogue Scale for pain (our outcome of interest here) |
Other bias |
Low risk |
Appeared free from other sources of bias |