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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Paolucci 2017.

Study characteristics
Methods Study design: RCT (NCT02231554)
Setting: Italy, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 53 (E1 = 26, E2 = 27)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 61
Sex (female): 82%
Interventions Exercise Group 1 (E1): Feldenkrais method: sessions aim to increase self‐awareness of movement and pain, and to improve trunk mobility by teaching participants how to perform functional movements without pain; type = functional restoration; duration = 5 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Back School: sessions run by physicians taught general anatomical information about the spine, muscle stretching, core reinforcement, postural and diaphragmatic breathing exercises; type = mixed; duration = 5 weeks; dose = low; design = standardised; delivery = group; additional intervention = back school
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Waddell Disability Index Score); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 13 weeks (short)
Notes Conflicts of interest: None to declare
Funding source: Not reported
Other: Information modified for author contact
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised to treatment groups at a 1:1 ratio according to a computer‐generated randomisation list (using www.random.org).
Allocation concealment (selection bias) Low risk Patient’s allocation was printed and hidden under a patch by an independent researcher; patch was only removed by another independent researcher with patient; clinical assessor was kept blinded.
Blinding of participants and personnel (performance bias)
All outcomes Low risk 1. Patients could not be blinded due to the nature of the treatments; 2. Both groups receiving novel care; unlikely to be able to access protocols outside of study context
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 here that providers could significantly alter their delivery; most likely situation is for provider in control group to put in extra effort, but here, control intervention was standardised
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk 1. Outcome assessors of the outcomes of interest (pain and disability) were the participants themselves, who could not be blind 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. Neither treatment is obviously better than the other; no reason to alter patient response.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. Two subjects of 53 dropped out during the training and were not considered in the study; one subject was not assessed at T2; thus, we used the last‐observation‐carried‐forward method.
Participants analysed in group allocated (attrition bias) High risk 1. Excluded patients who were not compliant; 2. By excluding non‐compliant patients, analysis was biased to make intervention appear more effective than it otherwise would have been.
Selective reporting (reporting bias) Low risk 1. No published protocol, but all analysis were performed and reported as described in methods.
Groups similar at baseline (selection bias) Low risk Participants in the two treatment groups were similar at baseline on age, sex, body mass index, pain and disability; did not measure duration of pain symptoms
Co‐interventions avoided or similar (performance bias) Low risk All patients were instructed not to take any new medication of nonsteroidal anti‐inflammatory drugs during the study protocol and not to undergo other rehabilitation approaches (those who did so dropped out of the study).
Compliance acceptable in all groups (performance bias) Low risk Excluded patients who attended fewer than 9 (out of 10) lessons; compliance was at least 90%.
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. Within each outcome, participants in each treatment group were measured using the same tool and at the same time point; 2. Visual Analogue Scale (for pain) and Waddell score (for disability) are well‐validated tools in the context of low back pain.
Other bias Low risk Appeared free from other sources of bias