| Study characteristics |
| Methods |
Study design: RCT (NCT01061632)
Setting: Sweden, healthcare
Exercise groups: 2
Comparison groups: 0 |
| Participants |
Number of participants: 70 (E1 = 35, E2 = 35)
Chronic LBP duration: 326 weeks (long)
Neurological/radicular symptoms: No participants
Mean age (years): 42
Sex (female): 56% |
| Interventions |
Exercise Group 1 (E1): High load lifting (deadlifts) focussing on strengthening core back muscles; type = core strengthening; duration = 8 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education
Exercise Group 2 (E2): Low load lifting: stepped programme aiming to train participants to use their back muscles appropriately during everyday activities; type = core strengthening; duration = 8 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 8.7 weeks (short); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: Visare Norr, Sweden; Norrbottens County Council, Sweden
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
For each group, randomisation was performed by applying a computer‐generated procedure of n out of N. |
| Allocation concealment (selection bias) |
Low risk |
An investigator, who had not met any of the participants, and who was blinded to all patient characteristics, performed a blinded randomisation procedure to provide a concealed allocation. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded due to the nature of the interventions; 2. No obvious better intervention; both groups were receiving active care. |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Two different physiotherapists delivered the intervention; each was specialised in the intervention; explicit list of interventions; unlikely to have deviated |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for all outcomes were the patients, who could not be blinded due to the nature of the interventions; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Unlikely that the lack of outcome assessor (participant) blinding altered judgement significantly, as there was no clearly "better" intervention; no significant differences between groups |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 3 patients lost to follow‐up at earliest time point; one gave the reason of adverse effects, the other 2 had no reason. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Participants were analysed according to their allocated treatment group. |
| Selective reporting (reporting bias) |
Low risk |
1. Registered protocol NCT01061632: all analyses conducted as described, except secondary outcome "functional capacity" from protocol not reported, seemed to be reported in another article |
| Groups similar at baseline (selection bias) |
Low risk |
All relevant baseline characteristics were reported and were similar between treatment groups. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Report did not mention any acknowledgement of co‐interventions during treatment period. |
| Compliance acceptable in all groups (performance bias) |
High risk |
High load lifting participants attended a mean of 11/12 sessions (92%), while the low load motor control group attended a mean of 6.1/12 sessions (51%); compliance was not acceptable in the low load motor control group. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All outcome assessments were similar between treatment groups in terms of timing, tools, etc.; 2. Visual Analogue Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are well‐validated tools in the context of low back pain. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
