Study characteristics |
Methods |
Study design: RCT
Setting: Switzerland, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 103 (E1 = 55, E2 = 48)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 40
Sex (female): 39% |
Interventions |
Exercise Group 1 (E1): Post‐functional restoration programme: warm‐up (15 minutes), core strengthening exercises, exercise for trunk flexor and extensor, upper and lower limb muscle using equipment, functional tasks, stretching (15 minutes); type = mixed; duration = 15 weeks; dose = high; design = partially individualised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Post‐functional restoration programme: written description of the exercises they performed during functional restoration, recommended to continue at home; type = mixed; duration = 15 weeks; dose = high; design = individualised; delivery = independent with follow‐up; additional intervention = psychological therapy |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 15 weeks (moderate); 52 weeks (long) |
Notes |
Conflicts of interest: None to declare
Funding source: No funding received
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation occurred on completion of functional multidisciplinary rehabilitation by means of sequentially numbered envelopes that were prepared in advance by a person who was not involved. |
Allocation concealment (selection bias) |
Low risk |
Randomisation occurred on completion of functional multidisciplinary rehabilitation by means of sequentially numbered envelopes that were prepared in advance by a person who was not involved in the study. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Assumed not possible |
Blinding of care provider (performance bias) |
High risk |
Assumed not possible |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Evaluators were not blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Thirteen subjects (23%) out of the 56 patients enrolled in the exercise programme group did not complete the exercise programme. |
Participants analysed in group allocated (attrition bias) |
Low risk |
According to the intention‐to‐treat principle, analyses were done using all randomised participants who provided any follow‐up data. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
No significant difference was found between groups. |
Co‐interventions avoided or similar (performance bias) |
Unclear risk |
Not described |
Compliance acceptable in all groups (performance bias) |
Low risk |
No patient had to be excluded because of missing more than six exercise sessions. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |