| Study characteristics |
| Methods |
Study design: RCT (NCT00454792)
Setting: Denmark, healthcare
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 100 (E1 = 51, C1 = 49)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 46
Sex (female): 68% |
| Interventions |
Exercise Group 1 (E1): Exercises for stabilising muscles in the low back and abdomen, dynamic exercises, exercises for postural instability, light physical fitness training; type = core strengthening & aerobic; duration = 10 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (advised to avoid hard physical activity and to rest lying down 2 x 1 hour per day and instructed to wear a lumbar belt) |
| Outcomes |
Core outcomes reported: Pain (Numeric Rating Scale); function (Roland‐Morris Disability Questionnaire); work (sick leave (by text)); HRQoL (EuroQol 5D ); Global Perceived Health or Recovery (Global Perceived Health or Recovery (global assessment (7‐point))
Follow‐up time periods available for syntheses: 10 weeks (short); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: VELUX Foundation
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
On receiving the completed baseline questionnaire, the project secretary allocated each patient into one of the two intervention groups. |
| Allocation concealment (selection bias) |
Low risk |
The researchers were masked to group assignment. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Support for judgement was not available. |
| Blinding of care provider (performance bias) |
High risk |
Support for judgement was not available. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The researchers analysing the data were blinded to patient identification as the study participants were given a random identification number. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
At the end of the intervention period, 78 patients had completed the full treatment programme (dropout rate 22%). |
| Participants analysed in group allocated (attrition bias) |
Low risk |
All data were analysed using the intention‐to‐treat (ITT) principle. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
There were no significant differences between the two groups regarding any of the baseline variables, including patient expectations of treatment effectiveness. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
interventions equal between groups |
| Compliance acceptable in all groups (performance bias) |
Low risk |
On average, patients participated in 84% of the sessions in the rest group or 91% of sessions if only those who completed the intervention were considered. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
