van der Roer 2008.
| Methods | RCT; 'randomization lists independently generated using random number tables' | |
| Participants | 114 patients, aged 18–65 years, a new episode of non‐specific CLBP lasting > 12 weeks recruited by physiotherapists. Exclusion criteria were: specific LBP, e.g. infection, tumour, osteoporosis, rheumatoid arthritis, fracture, inflammatory process, radicular syndrome, or cauda equina syndrome; advice by medical practitioner not to perform physically straining activities; pregnancy or pelvic girdle pain; and legal involvement related to LBP or work disability. | |
| Interventions | Behavioural treatment (I): Intensive group training (exercise therapy, back school, behavioural principles) 10 individual sessions + 20 group sessions (N = 60) Reference treatment (R): Guideline based treatment (treated individually and the number of treatment sessions was at the discretion of the physiotherapists) approximately 13 sessions (N = 54) |
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| Outcomes | No statistically significant differences were found for functional status. At 26 weeks, (I) reported significantly lower pain intensity, however this difference was absent after 1 year follow‐up. The cost‐effectiveness planes indicated no significant differences in cost‐effectiveness between the two groups. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | 'randomisation lists independently generated using random number tables' |
| Allocation concealment? | Low risk | Adequate |
| Blinding? All outcomes ‐ patients? | High risk | "Due to the pragmatic design both patients and physiotherapists could not be blinded for the interventions." |
| Blinding? All outcomes ‐ providers? | High risk | as above |
| Blinding? All outcomes ‐ outcome assessors? | High risk | self‐reported outcomes, patients not blinded |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | Figure 1 described and acceptable drop out rate |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | "An intention‐to‐treat analysis was conducted for each follow‐up moment using multilevel modelling." |
| Free of selective reporting? | Low risk | physical measures were not reported, but are only a secondary outcome |
| Similarity of baseline characteristics? | Low risk | Table 1 |
| Co‐interventions avoided or similar? | Unclear risk | co‐interventions discouraged but not checked |
| Compliance acceptable? | High risk | "in 18% of the patients the protocol was not adequately followed" |
| Timing outcome assessments similar? | Low risk | Figure 1 |