| Study characteristics |
| Methods |
Study design: RCT (NCT02304120)
Setting: Switzerland, healthcare
Exercise groups: 2
Comparison groups: 0 |
| Participants |
Number of participants: 22 (E1 = 11, E2 = 11)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 55
Sex (female): 50% |
| Interventions |
Exercise Group 1 (E1): Sensorimotor training: balance training involving standing on a labile, swaying platform; type = core strengthening; duration = 4.5 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = physiotherapy
Exercise Group 2 (E2): Low intensity cardio on a treadmill, elliptical, or stationary bike for 15 minutes at a comfortable pace; type = aerobic; duration = 4.5 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = physiotherapy |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 8.5 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Cantonal Department of Health and Social Services, Canton of Argovia; Reha Rheinfelden, Switzerland
Other: Information modified for author contact, SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation schedule using permuted blocks of random sizes; block sizes were not disclosed, to ensure concealment. |
| Allocation concealment (selection bias) |
Low risk |
An independent third party created the randomisation list, which was stored away from the study team to ensure concealment of treatment allocation. |
| 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. Concomitant care was not restricted but sham exercise was also exercise based so the distinction between comparator and treatment group was less obvious; no changes in lifestyle were reported. |
| 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. Protocol was explicit; no decision‐making by study personnel; opinion may have transferred to patients but study personnel were not responsible for other care. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain and function 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. No obvious reason for patient to alter response; potentially due to the novel nature of the experimental group, but control group was receiving exercise which they presumably thought was effective. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate was 4.5% (1/22). |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Intention‐to‐treat analysis was performed; those who dropped out before the end had their missing data imputed based on the carry‐forward method. |
| Selective reporting (reporting bias) |
Low risk |
1. T‐test analysis plan in protocol was not executed due to non‐normal distribution of data and heteroscedasticity of variance. Instead, a more robust method was used. |
| Groups similar at baseline (selection bias) |
Low risk |
Both treatment groups were similar on all relevant baseline characteristics, except duration of symptoms was not measured. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
No mention of co‐interventions in the study report |
| Compliance acceptable in all groups (performance bias) |
Low risk |
81.1% of people attended all sessions and 4 of 22 attended 8 of 9; therefore 100% of people attended at least 8 sessions. |
| 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. Oswestry Disability Index (for function), and Visual Analogue Scale (for pain) are all well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
