| Study characteristics |
| Methods |
Study design: RCT
Setting: Iran, healthcare
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 40 (E1 = 20, C1 = 20)
Chronic LBP duration: 40.42 months (long)
Neurological/radicular symptoms: No participants
Mean age (years): 31
Sex (female): 0% |
| Interventions |
Exercise Group 1 (E1): Stabilisation exercises plus physiotherapy, including some stretching; type = core strengthening; duration = 4 weeks; dose = not reported; design = partially individualised; delivery = individual; additional intervention = electrotherapy & physiotherapy
Comparison Group 1 (C1): Other conservative treatment (physical therapy) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 4 weeks (short) |
| Notes |
Conflicts of interest: Not reported
Funding source: Not reported
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Subjects 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. Both groups getting in depth care |
| 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. One physiotherapist treated both groups; protocol was explicit, no decision‐making by personnel; opinion may have transferred to patients but no clear deviations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcomes in question were assessed by the patients who were not blinded to the intervention; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Although control group was receiving no thorough active component, likely that to the participants it was classified as activity, no reason to alter response |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Technically, the dropout rate was zero because the two patients who did drop out were replaced. |
| Participants analysed in group allocated (attrition bias) |
Unclear risk |
1. Subjects were replaced if dropped out; 2. Dropout rate was sufficiently small that the missing data (and lack of intention‐to‐treat analysis) was unlikely to have affected overall conclusions. |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication all outcomes and analyses fully reported; no obvious omissions |
| Groups similar at baseline (selection bias) |
Low risk |
Both treatment groups were similar on all relevant baseline characteristics. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
No report or description of dealing with co‐interventions in this study |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Seemed like protocol had to completed in full for inclusion in the analysis; assuming compliance was 100% |
| Timing of outcome assessment similar in all groups (detection bias) |
High risk |
1. There were two patients that dropped out part‐way through the study, and replaced; while these patients had the same length of study period, their start and end were staggered from the rest; 2. Oswestry Disability Index (for function), and Visual Analogue Scale (for pain) are all well‐validated tools in the low back pain context. |
| Other bias |
High risk |
Five subjects were substituted for new ones due to inability to complete the treatment; these patients had an Oswestry and pain higher than average; no mention on how randomisation was preserved |
