Study characteristics |
Methods |
Study design: RCT (NCT00256373)
Setting: Denmark, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 272 (E1 = 129, E2 = 143)
Chronic LBP duration: 1.2 years (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 41
Sex (female): 44% |
Interventions |
Exercise Group 1 (E1): Warm‐up (aerobic training), back, gluteus, and abdominal strengthening using machines and circuit training, sports; type = mixed; duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = advice/education & psychological therapy & other & physiotherapy
Exercise Group 2 (E2): Specific muscle training exercises to strengthen and shorten the muscles in back and gluteus region (developed by Oefeldt); type = core strengthening; duration = 12 weeks; dose = high; design = partially individualised; delivery = individual; additional intervention = none |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); work (ability to work); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (global perceived outcome (3‐point))
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
Notes |
Conflicts of interest: None to declare
Funding source: Apotekerfonden af 1999, Sygekassernes Helsefond; The Danish National Board of Health
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Patients were allocated by a separate secretary. |
Allocation concealment (selection bias) |
Low risk |
Allocated by a separate secretary |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The study was designed as a prospective, single‐blinded clinical trial. |
Blinding of care provider (performance bias) |
Low risk |
Assumed not possible |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
All physical examinations at trial visits were performed by one physician who was blinded to the treatment group. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Eleven patients in each group: A (9%)/B (8%) dropped out during the treatment period. |
Participants analysed in group allocated (attrition bias) |
Low risk |
Whether analysed on an intention‐to‐treat basis or based on actual data, the outcome obtained using comparative statistics was similar. |
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 groups. |
Co‐interventions avoided or similar (performance bias) |
Unclear risk |
Not described |
Compliance acceptable in all groups (performance bias) |
Low risk |
All patients were encouraged to increase physical activity during everyday life. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |