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

Kim 2018a.

Study characteristics
Methods Study design: RCT
Setting: South Korea, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 77 (E1 = 38, E2 = 39)
Chronic LBP duration: 9.65 months (moderate)
Neurological/radicular symptoms: Not specified
Mean age (years): 43
Sex (female): 57%
Interventions Exercise Group 1 (E1): Sling exercises with elastic bands, focussing on engaging core muscles, with warm‐up (stretching); type = core strengthening; duration = 12 weeks; dose = low; design = individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Traditional trunk stabilisation exercises focussing on core muscles Includes stretching warm‐up as well; type = core strengthening; duration = 12 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Outcomes Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate)
Notes Conflicts of interest: Not reported
Funding source: Not reported
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed "using a stratified randomization procedure with a permuted block size of 4 using a computer that balanced ages (< 40 or ≥ 40 years) and sexes (male or female)".
Allocation concealment (selection bias) Low risk "Randomization codes were kept in sealed envelopes with consecutive numbering" to keep treatment allocation 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 the intended interventions because neither treatment group was better
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 the intended interventions because the two treatment groups were distinct, yet neither was perceived as better
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. Although the sling exercise seemed relatively novel, both groups were receiving similar active treatments; unlikely to alter patient response.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. Dropout rate was 5%.
Participants analysed in group allocated (attrition bias) Low risk 1. Intention‐to‐treat analysis was used.
Selective reporting (reporting bias) Low risk 1. No linked protocol or statistical analysis plan found: within this publication all outcomes and analyses were fully reported.
Groups similar at baseline (selection bias) High risk Groups were balanced on all relevant characteristics at baseline, except one group was almost significantly older than the other.
Co‐interventions avoided or similar (performance bias) Low risk "Participants were not allowed to receive other treatment for back pain during the intervention period".
Compliance acceptable in all groups (performance bias) High risk No information about compliance, adherence or attendance 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 Numeric Rating 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