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

Mazloum 2018.

Study characteristics
Methods Study design: RCT
Setting: Iran, healthcare
Exercise groups: 2
Comparison groups: 1
Participants Number of participants: 60 (E1 = 20, E2 = 20, C1 = 20)
Chronic LBP duration: 32 months (moderate)
Neurological/radicular symptoms: No participants
Mean age (years): 40
Sex (female): Not reported
Interventions Exercise Group 1 (E1): Selective Pilates moves: shoulder bridge, side kick, one leg stretch, hundred, roll up, swan dive, swimming, one leg circle, double arm stretch, spine twist; type = Pilates; duration = 6 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Extension‐based exercises: deep breathing in prone, passive trunk extension on elbows in prone, passive trunk extension on hands in prone, passive trunk extension in standing, knee to chest in crook lying, trunk flexion in sitting on a chair; type = stretching; duration = 6 weeks; dose = low; design = standardised; delivery = not specified; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention)
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 10 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) Unclear risk Participants were "randomly allocated".
Allocation concealment (selection bias) High risk Insufficient information to determine whether treatment allocation was concealed
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. Unlikely that lack of patient blinding caused deviations from intended interventions; experimental group was structured and controlled by care providers, and control group was purposely broad
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 intended interventions; experimental group was structured, and control group was purposely broad
Blinding of outcome assessment (detection bias)
All outcomes High 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. Likely that lack of patient blinding introduced bias to outcome assessments, as the experimental groups were clearly "better" than the control; study results for all outcomes supported this.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. Dropout rate was 22% (13/60); 2. No comparison of dropout subjects to non‐dropouts to determine if missing data introduced selection bias; 3. Missingness could be caused by increased disability from low back pain; 4. Rate of missing subjects in each group was very similar.
Participants analysed in group allocated (attrition bias) Low risk 1. All patients were analysed according to the allocation to which they were randomised.
Selective reporting (reporting bias) Low risk 1. No linked protocol or statistical analysis plan found: within this article everything was fully reported.
Groups similar at baseline (selection bias) Low risk Both treatment groups were similar on all relevant baseline characteristics, except there was no report of patient sex.
Co‐interventions avoided or similar (performance bias) Low risk Avoided co‐interventions by excluding patients receiving physical therapy or other treatment interventions in the past six months; no mention of medication use
Compliance acceptable in all groups (performance bias) High risk No information about compliance/adherence/attendance of interventions in this study
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