| Study characteristics |
| Methods |
Study design: RCT
Setting: Spain, general population
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 112 (E1 = 57, C1 = 55)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 71
Sex (female): 100% |
| Interventions |
Exercise Group 1 (E1): Physical therapy and 2, 1‐hour pilates sessions weekly for 6 weeks including: strengthening exercises involving the use of implements such as fitballs, magic rings and TheraBands; flexibility and joint mobility exercises; breathing exercises; and motor control and posture correction tasks; type = Pilates; duration = 6 weeks; dose = low; design = partially individualised; delivery = not specified; additional intervention = electrotherapy & manual therapy
Comparison Group 1 (C1): Other conservative treatment (physical therapy) |
| Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 6 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated table of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Treatment allocations were concealed using sealed, opaque and consecutively numbered envelopes kept in a locked location; opened in sequence by an independent administrator. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to their group assignment due to the nature of the interventions; 2. Patients encouraged to make no changes to current exercise regimen; no information given on deviations |
| 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 caused deviations from the intended intervention, as the only contact with control patients was in physiotherapy sessions, which were structured. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain and function were patients themselves, who could not be blinded to allocation due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Because there was a significant difference between Pilates and control group interventions, there was likely a bias in outcome assessments due to lack of blinding; study results supported this. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate was 8% (9/112) overall. |
| Participants analysed in group allocated (attrition bias) |
Unclear risk |
1. Stated that intention‐to‐treat was done, however, excluded those who were non‐compliant; 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. All planned analyses were executed and reported for all primary and secondary outcomes. |
| Groups similar at baseline (selection bias) |
High risk |
At baseline, the control group was significantly older (by 3 years) than the Pilates group; no report of duration of symptoms; baseline pain and function were similar. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Patients were allowed to continue their regular extra‐curricular exercises without regulation. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Participants were excluded from the study if they missed more than two therapeutic sessions, thus compliance was at least 83% (10/12 sessions). |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All patient outcome assessments were identical, regardless of treatment group allocation; 2. Numeric Rating 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 |
