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

Monticone 2014.

Study characteristics
Methods Study design: RCT
Setting: Italy, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 20 (E1 = 10, E2 = 10)
Chronic LBP duration: 14.45 months (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 58
Sex (female): 55%
Interventions Exercise Group 1 (E1): Motor training (spinal stabilising exercises), stretching; type = core strengthening; duration = 8 weeks; dose = high; design = individualised; delivery = not specified; additional intervention = advice/education & psychological therapy & manual therapy
Exercise Group 2 (E2): Stretching and muscle strengthening; type = stretching & strengthening; duration = 8 weeks; dose = low; design = individualised; delivery = not specified; additional intervention = advice/education & manual therapy
Outcomes Core outcomes reported: Pain (Numeric Rating Scale); function (Oswestry Disability Index); work (ability to participate/perform usual activities); HRQoL (36‐Item Short Form Survey (Italian))
Follow‐up time periods available for syntheses: 8 weeks (short); 13 weeks (moderate)
Notes Conflicts of interest: Not reported
Funding source: EuroSpine Task Force on Research
Other: Information modified for author contact
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using a list of blinded treatment codes previously generated by a biostatistician
Allocation concealment (selection bias) Low risk Automatic assignment system in order to conceal the allocation
Blinding of participants and personnel (performance bias)
All outcomes Low risk In order to limit expectation bias and reduce problems of cross‐over, the patients were blinded to the study hypothesis.
Blinding of care provider (performance bias) High risk The physiatrists, the psychologist, the physiotherapists, and the patients could not be blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk In order to limit expectation bias and reduce problems of cross‐over, the patients were blinded to the study hypothesis.
Incomplete outcome data (attrition bias)
All outcomes Low risk All of the participants completed the treatment interventions and all of the assessment tests.
Participants analysed in group allocated (attrition bias) Low risk All of the participants completed the treatment interventions and all of the assessment tests.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk There were no differences between the groups in terms of age, body mass index, or the duration of pain before study enrolment.
Co‐interventions avoided or similar (performance bias) Low risk No major pharmacological agents were allowed, although mild analgesics and non‐steroidal anti‐inflammatory drugs were permitted.
Compliance acceptable in all groups (performance bias) Low risk All of the participants completed the treatment interventions and all of the assessment tests.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.