Danielsen 2000.
| Methods | Randomisation "by random number table" | |
| Participants | 63 patients aged 22 to 58 years (range), four weeks after operation for lumbar disc herniation (arcotomy in 36 patients, microsurgical in 27 patients, N = 3 at L3‐L4, N = 34 at L4‐L5, N = 24 L5‐S1) | |
| Interventions | (I) Rehabilitation programme (N = 39): from week 4 to week 12, three times per week (40 minutes a session) exercise therapy; exclusively active, no manual intervention or physical therapist, strengthen muscles (various apparatus), participant tailored. (C) (N = 24): weeks 1 through 3: standard programme, then follow‐up consultation (info about clinical course and clinical examination) with physical therapist every two weeks for eight weeks, formula with mild home exercise programme, relaxing and resting the back, and resuming daily activities gradually, avoiding any kind of heavy work at home | |
| Outcomes | Pain intensity (VAS) absolute values (abs) and mean improvement (MI) (95% CI) at six months: (I) abs 2.3 (1.5 to 3.1) (MI) 3.7 (2.7 to 4.7), (C) abs 3.6 (2.5 to 4.7) (MI) 2.0 (0.7 to 3.3); for functional status (RDQ) (I) abs 5.1 (3.1 to 7.1) (MI) 8.9 (7.0 to 10.8), (C) abs 6.2 (4.1 to 8.4) (MI) 5.4 (3.0 to 7.8). For pain at 12 months: (I) abs.2.8 (1.9 to 3.7) (MI) 3.2 (2.1 to 4.3), (R) abs 3.9 (2.6 to 5.7) (MI) 1.8 (0.5 to 3.1); (RDQ) (I) abs 5.3 (3.2 to 7.4) (MI) 8.7 (6.8 to 10.6), (C) abs 6.3 (3.8 to 8.8) (MI): 5.3 (2.6 to 8.0). Absolute RDQ values minor advantage for (I): 6 and 12 months, on MI significantly larger scores for (I). Pain, both abs. MI significantly better for (I), 12 months no differences between groups. Significantly more participants in (I) participation in daily activities (subscale WONCA) at six months. At 6 and 12 months, no significant differences for overall health or sick leave. No significant changes for analysis with only complete follow‐up | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Result of the allocation was handed over to the project co‐ordinator |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | Active rehabilitation versus mild programme at home |
| Blinding (performance bias and detection bias) All outcomes ‐ care providers? | High risk | Active rehabilitation versus mild programme at home |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Patient reported |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | Training three/39 = 8%, five/39 = 13% Control two/24 = 8% |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | ITT, imputation |
| Selective reporting (reporting bias) | Low risk | RDQ, Wonca and VAS |
| Similarity of baseline characteristics? | High risk | Roland and sick leave differences, Table 2 |
| Co‐interventions avoided or similar? | Unclear risk | Unclear from text |
| Compliance acceptable? | Unclear risk | Unclear from text |
| Timing outcome assessments similar? | Low risk | Six, 12 months |