| Study characteristics |
| Methods |
Study design: RCT
Setting: Germany, general population
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 63 (E1 = 22, E2 = 20, C1 = 21)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 74
Sex (female): 71% |
| Interventions |
Exercise Group 1 (E1): Bridging exercises with biofeedback: participants performed a series of floor exercises aimed at strengthening their core while laying flat on the ground using Wii Fit balance boards; type = core strengthening; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Bridging exercises only: participants performed a series of floor exercises aimed at strengthening their core while laying flat on the ground; type = core strengthening; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention) |
| Outcomes |
Core outcomes reported: Function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 12 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Seventh Framework Programme of the European Commission (Agreement No. 611218)
Other: Information modified for author contact; sufficient data not available for inclusion in meta‐analyses |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was performed with drawing pre‐prepared opaque envelopes containing the group assignment after inclusion and measuring all baseline data. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation was performed with drawing pre‐prepared opaque envelopes containing the group assignment after inclusion and measuring all baseline data. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to their intervention due to the nature of the treatments; 2. Unlikely lack of patient blinding caused deviations; actual exercises in each group were identical and with same therapists; unlikely for participants (65+) to seek biofeedback intervention outside of study |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers (therapists) could not be blinded to the intervention as they were responsible for delivering the interventions; 2. Nature of the intervention made this unlikely, either used the biofeedback or did not; no transfer of opinion because patients had low user acceptance anyway |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for function outcome 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. Exercise versus no treatment was likely to be altered by knowledge of assignment; also possible biofeedback group was frustrated and this influenced outcome assessment |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate was 27% (17/63), which is not an acceptable rate; 2. Reasons for withdrawal from study for most participants were conflicting patient schedules due to a delay in the original study timeline; no data on how dropouts compared to the rest |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Frequent connectivity issues led to the biofeedback group performing exercises similar to the standard group; were still analysed in biofeedback group |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication fully reported and analysed; did not report traditional pain scales, but no obvious omissions from the analysis |
| Groups similar at baseline (selection bias) |
Low risk |
At baseline, participants across all treatment groups were similar on age, body mass index, function, sleep quality and fall risk; there were no data reported on sex or duration of symptoms. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
No mention of whether or not the study limited or measured co‐interventions |
| Compliance acceptable in all groups (performance bias) |
High risk |
Participant attendance was apparently recorded, but exclusion was only reported when participants missed > = 6 sessions (out of 24 total); 24 patients did not complete due to equipment issues. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All participants were assessed identically regardless of treatment group assignment; 2. Oswestry Disability Index and Roland‐Morris Disability Questionnaire (both for function) are both well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
