Study characteristics |
Methods |
Study design: RCT
Setting: Italy, healthcare
Exercise groups: 1
Comparison groups: 1 |
Participants |
Number of participants: 14 (E1 = 7, C1 = 7)
Chronic LBP duration: 14.58 months (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 52
Sex (female): 57% |
Interventions |
Exercise Group 1 (E1): Posture called "standing posture with flexion of the trunk" in addition to physiotherapy: position maintained from 30 to 60 seconds and was repeated 5 times, with a one‐minute break between repetitions; type = core strengthening & stretching; duration = 4 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Other conservative treatment (physical therapy) |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 4 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 |
Randomisation not described beyond the fact that patients were "randomly divided" into treatment groups |
Allocation concealment (selection bias) |
High risk |
Not described beyond the fact that patients were "randomly divided" into treatment groups |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Unlikely that the patients could be blinded as to whether or not they received an extra exercise at the end of their physiotherapy routines; 2. Unlikely that a lack of patient blinding led to deviations from the intended intervention because the difference between treatment groups was only a single exercise, and it required physiotherapy guidance |
Blinding of care provider (performance bias) |
Unclear risk |
1. Care providers (physiotherapist) could not be blinded to intervention because they delivered it, and had to know whether or not to deliver the exercise of interest; 2. Very possible that lack of physiotherapy blinding led to deviations from intervention because the article explicitly stated that physiotherapists could use their discretion and did not use a strict protocol; 3. Likely that any deviations from intended intervention due to lack of physiotherapist blinding were balanced between groups because both groups received the same unstructured physio treatment |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Since the outcome assessors for pain and disability were the patients, it is unlikely they were blinded to the intervention allocation; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. One group was getting "conventional" care while the other was getting something supplemental; could alter assessment. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. No dropouts from baseline to time point 1; there were dropouts at time point 2, but these outcome data were incomplete and not extracted for systematic review. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to their assigned treatment group, according to intention‐to‐treat analysis |
Selective reporting (reporting bias) |
Low risk |
1. No linked protocol found: no obvious omissions in outcomes or analyses |
Groups similar at baseline (selection bias) |
Low risk |
No statistically significant between‐group differences in baseline age, sex, body mass index, symptom duration, pain or disability; nearly clinically significant difference in body mass index and disability: worse in control |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Care providers were not given any strict protocols (especially around co‐interventions) to follow in their "usual care", but they could have applied this equally to both treatment groups. |
Compliance acceptable in all groups (performance bias) |
High risk |
Compliance (attendance) was not reported in the study, and so not able to determine exact compliance |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All outcome assessments were carried out with the same tools and at the same time for both treatment groups, up until T1 assessments; only experimental followed to T2; 2. Numeric Rating Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are validated tools in low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |