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 |