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

Sousa 2009.

Study characteristics
Methods Study design: RCT
Setting: Brazil, healthcare
Exercise groups: 1
Comparison groups: 1
Participants Number of participants: 60 (E1 = 30, C1 = 30)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 46
Sex (female): 72%
Interventions Exercise Group 1 (E1): Global muscular relaxation, exercises to strengthen the abdominal muscles with and without biofeedback; type = strengthening; duration = 8 weeks; dose = low; design = standardised; delivery = group; additional intervention = psychological therapy & anti‐inflammatory/analgesics
Comparison Group 1 (C1): Other conservative treatment (anti‐inflammatory/analgesics)
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 8 weeks (short)
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) Unclear risk Patients were randomised in either the control group or the treatment groups.
Allocation concealment (selection bias) High risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described
Blinding of care provider (performance bias) High risk Not described
Blinding of outcome assessment (detection bias)
All outcomes Low risk The instruments used for assessment were a Visual Analogue Scale, Schober Index, Roland Morris Disability Questionnaire, Becks Depression Scale.
Incomplete outcome data (attrition bias)
All outcomes Low risk Seven patients were excluded as a result of being absent during the two‐month period, and one from the treatment group due to reported symptoms.
Participants analysed in group allocated (attrition bias) High risk Not included
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk The groups were homogenous in relation to demographic variables (Table 1).
Co‐interventions avoided or similar (performance bias) Unclear risk Both groups were instructed to use paracetamol, 500 mg, every six hours, if necessary, when feeling pain.
Compliance acceptable in all groups (performance bias) Low risk Not described
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.