Study characteristics |
Methods |
Study design: RCT (NCT00908102)
Setting: Finland, occupational
Exercise groups: 2
Comparison groups: 1 |
Participants |
Number of participants: 126 (E1 = 43, E2 = 43, C1 = 40)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 45
Sex (female): 32% |
Interventions |
Exercise Group 1 (E1): Light mobilisation and exercises, progressive exercises, home exercises; type = mixed; duration = 12 weeks; dose = high; design = partially individualised; delivery = group; additional intervention = advice/education & psychological therapy & relaxation
Exercise Group 2 (E2): Progressive exercise using equipment to target trunk muscles, stretching, home exercises; type = mixed; duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = advice/education
Comparison Group 1 (C1): Other conservative treatment (education) |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index); work (sickness absence days); HRQoL (HRQoL 15D instrument)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
Notes |
Conflicts of interest: During physical medicine unit (PMU) interventions, MH was the head physician of the PMU. ST is the Medical Director of DBC International.
Funding source: Centenary Foundation of Kymi Corporation; Yrjo Jahnsson Foundation; Juho Vainio Foundation; Finnish Cultural Foundation
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
An independent biostatistician prepared the randomisation scheme using a computer‐generated randomisation table. |
Allocation concealment (selection bias) |
Low risk |
Based on the randomisation scheme, a research assistant prepared sealed envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Due to the nature of the interventions, the participants and occupational health professionals were not blinded for the group assignment after randomisation. |
Blinding of care provider (performance bias) |
High risk |
Due to the nature of the interventions, the participants and OH professionals were not blinded for the group assignment after randomisation. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Author contact: Doctors likely not blinded, patients not blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Author contact: dropout differed. |
Participants analysed in group allocated (attrition bias) |
Low risk |
All statistical analyses were performed at employee level, according to the intention‐to‐treat principle. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
Randomisation was successful and the treatment arms were comparable regarding the relevant demographic factors. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Support for judgement was not available. |
Compliance acceptable in all groups (performance bias) |
Unclear risk |
Author contact: compliance was dropout rate; did not add clarity for this item |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |