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. |