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 |