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

Lee 2016a.

Study characteristics
Methods Study design: RCT
Setting: South Korea, healthcare
Exercise groups: 2
Comparison groups: 1
Participants Number of participants: 36 (E1 = 15, E2 = 15, C1 = 6)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 44
Sex (female): Not reported
Interventions Exercise Group 1 (E1): Strength exercises performed on a mat and with an exercise ball (e.g. bridge, plank, squat, push‐ups, back extension), walking exercises were performed with a step box, warm‐up and cool‐down stretching step exercises; type = mixed; duration = 12 weeks; dose = high; design = standardised; delivery = not specified; additional intervention = none
Exercise Group 2 (E2): Strength training exercises including bridge, plank, squat, push‐ups and back extension, warm‐up and cool‐down stretching: core focussed; type = stretching & core strengthening; duration = 12 weeks; dose = high; design = standardised; delivery = not specified; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no description)
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 12 weeks (short)
Notes Conflicts of interest: None to declare
Funding source: Sangmyung University
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients were randomly divided; no further information given.
Allocation concealment (selection bias) High risk No information on treatment allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk 1. Patients could not be blinded to intervention because of the distinct nature of each treatment group; 2. Unlikely that patients' lack of blinding led to deviations from intended interventions because patients have little control over how the intervention is delivered
Blinding of care provider (performance bias) Low risk 1. Participants did not necessarily have a regular care provider; exercise instructors were not blinded to intervention, as they were delivering distinct exercise protocols; 2. Exercise instructors were delivering a group (probably) exercise that was standard, so unlikely that they deviated from exercise protocol for any participants
Blinding of outcome assessment (detection bias)
All outcomes High risk 1. Assessors of outcomes of interest (pain and disability) were participants themselves, who were not blinded to allocation because of how different each treatment group was; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Due to the differences between the control group and the active exercise groups, there is significant potential for patients' judgement to be biased when self‐evaluating pain and disability outcomes.
Incomplete outcome data (attrition bias)
All outcomes High risk 1. No description of dropout rate; 2. No evidence of non‐biased analysis; 3. Increased pain and decreased function could cause missing outcome; 4. No information; 5. No information
Participants analysed in group allocated (attrition bias) Low risk 1. Reasonable to assume that participants were analysed according to their original group allocation
Selective reporting (reporting bias) Low risk 1. No linked protocol found but within this paper all outcomes and analyses fully reported; no obvious omissions
Groups similar at baseline (selection bias) High risk All groups were similar at baseline on age; and body mass index, pain duration and sex were not reported, and nearly all outcome measures (including pain and disability) were very different among groups.
Co‐interventions avoided or similar (performance bias) High risk No reporting of co‐interventions; participants were all sedentary, and so were not likely participating in any physical activity outside of the study.
Compliance acceptable in all groups (performance bias) High risk No information on compliance
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. Assessment protocol was identical between groups; assuming survey delivery was the same for the control group; 2. Visual Analogue Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are well‐validated tools in the context of low back pain.
Other bias Low risk Under reported, no other apparent sources of bias