| Study characteristics |
| Methods |
Study design: RCT (IRCT2014081218760N1)
Setting: Iran, healthcare
Exercise groups: 2
Comparison groups: 0 |
| Participants |
Number of participants: 60 (E1 = 30, E2 = 30)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 53
Sex (female): 100% |
| Interventions |
Exercise Group 1 (E1): Pelvic floor muscle exercises plus usual physiotherapy care with transcutaneous electrical nerve stimulation, hot pack and therapeutic ultrasound; type = core strengthening; duration = 12 weeks; dose = low; design = standardised; delivery = independent with follow‐up; additional intervention = electrotherapy & heat/ice
Exercise Group 2 (E2): Regular physiotherapy exercises (focussing on abdominal and paravertebral muscles); type = core strengthening; duration = 12 weeks; dose = low; design = standardised; delivery = independent with follow‐up; additional intervention = electrotherapy & heat/ice |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 12 weeks (short) |
| Notes |
Conflicts of interest: Not reported
Funding source: Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Participants were "randomly assigned". |
| Allocation concealment (selection bias) |
High risk |
No information on treatment allocation concealment |
| 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. Unlikely that lack of care provider blinding led to deviation from intended intervention because interventions were all defined with specific protocols |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain 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. Likely that lack of patient blinding could have caused bias in outcome assessment because the experimental group could be perceived as better than the control |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. No description of dropout rate 2. Analysis dropped any missing values and there was no sensitivity analysis; 3. Increased pain and disability could cause missing data; 4. No information on dropout rate in either group; 5. No information on reasoning for any dropouts |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to the allocation to which they were randomised |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication all analyses and outcomes were fully reported. |
| Groups similar at baseline (selection bias) |
Low risk |
Groups were similar on age, sex (all female patients), body size, function and pain at baseline; duration of symptoms not reported |
| Co‐interventions avoided or similar (performance bias) |
High risk |
No information on co‐interventions presented in this study |
| Compliance acceptable in all groups (performance bias) |
Low risk |
No information on compliance, adherence or attendance in this study |
| 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. Visual Analogue Scale (for pain) and Oswestry Disability Index (for function) are well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
