| Methods |
Randomised according to a table of random numbers |
| Participants |
60 patients (aged 16 to 70 years), microdiscectomy after not responding to conservative treatment. Patients with reoperation other surgery as microdiscectomy without microscope (e.g. laminectomy). Interventions start immediately after surgery |
| Interventions |
(I) (N = 29) Total duration is 12 weeks, starting directly after surgery: out of bed from prone position, increased ADL and lumbar support (sitting). First six weeks home training (five to six times per day) with mobilisation of neural structures and low back, increased trunk strength (functional positions), correct work posture and pain coping. Second six weeks (five to six times per day) mainly intensive muscle strength and flexion exercises and cardiovascular exercises (in total: four instruction sessions). (C) Total duration 12 weeks, starting directly after surgery out of bed from side position, no increase in ADL and no lumbar support (sitting). First six weeks: abdominal exercises (once a day) lying position. Second six weeks: more intensive strength exercises, mobilisation of spine. No promotion of cardiovascular exercises (total: three instruction sessions) |
| Outcomes |
At two years: satisfaction (I) 88%, (C) 67%. Percentage of positive SLR (three weeks): (I) 0 (C) 7, significant difference. At 6, 12, 52 weeks: no significant differences. At 52 weeks: (I) 30 (14.8) extension increased and (C) flexion 42 (11.5) significantly increased. Patients pain free at 6 weeks: (I) 8 and (C) 4; no differences at 12, 52, 104 weeks. Leg pain intensity (VAS) (in patients with sciatica) at 6, 12, 52 weeks (mean, SD): (I) 1.0 (0.6), 1.5 (0.9) 2.7 (0.5), (C) 4.1 (2.9), 3.4 (2.2), 3.0 (1.9); statistically significant at 6 weeks, 12 weeks, not at 52 weeks. At five to seven years' follow‐up: (I) 52%, (C) 50% pain (leg); (I) 73% (C) 60% pain (back). Participants on sick leave at 12 weeks: (I) 10 (C) 15 (NS). At 52 weeks: (I) 120 (75) days and (C) 153 (107) days on sick leave. At two years: (I) 88% (C) 67% satisfied with result. (I) 10 = 40% (C) 8 = 33% no pain. During two to five years after surgery, no differences in days of sick leave: (I) 146 (SD: 243 days) (C) 157 days (SD: 203). On five to seven years' follow‐up, no differences in numbers of participants with leg pain: (I) 16/30 (C) 15/30 or in numbers of participants with back pain: (I) 22/30, (C) 18/30 |
| Notes |
Unpublished data were used |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Table of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Personal communication: nurse allocated participants |
| Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
Intensive versus less intensive |
| Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
Intensive versus less intensive |
| Blinding (performance bias and detection bias)
All outcomes ‐ outcome assessors? |
High risk |
Patient reported |
| Incomplete outcome data (attrition bias)
All outcomes ‐ drop‐outs? |
High risk |
5/23 = 22% 12‐week control |
| Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
Dropouts |
| Selective reporting (reporting bias) |
High risk |
Pain, not function, reported on a VAS |
| Similarity of baseline characteristics? |
Low risk |
Tables 1, 2, 3 |
| Co‐interventions avoided or similar? |
Unclear risk |
Unclear from text |
| Compliance acceptable? |
Unclear risk |
Uunclear, response low |
| Timing outcome assessments similar? |
Low risk |
12, 52 weeks |
