McGregor 2011.
| Methods | Randomised, four groups | |
| Participants | 140 participants, mean (SD) age 43 (11); 44 (10); 44 (11); 46 (11) years, male and female, with root symptoms and signs and MRI confirmation of lumbar disc herniation, primarily leg pain for a median of 20 to 32 months, who had discectomy, according to the surgeons’ routine practice | |
| Interventions | Rehabilitation (I1, n = 37): start six to eight weeks postop rehab programme, 12 one‐hour classes, aerobic fitness; stretching; stability exercises; strengthening and endurance training for the back, abdominal, and leg muscles; ergonomic training; advice on lifting and setting targets; and self motivation. Rehabilitation and booklet (I2, n = 42): same programme and educational booklet ‘Your Back Operation’. Control (C, n = 40): managed according to the relevant surgeon’s usual practice, which varied and was limited |
|
| Outcomes | Functional status (ODI) post‐treatment, mean change and 95% CI: (I1) ‐20 (‐14 to ‐25), (I2) ‐23 (‐16 to ‐29) and (C) ‐24 (‐19 to ‐29). At one year: (I1) ‐24 (‐18 to ‐29), (I2) ‐25 (‐20 to ‐31) and (C) ‐26 (‐21 to ‐31). Leg pain (VAS) post‐treatment, mean change and 95% CI: (I1) ‐33 (‐24 to ‐42), (I2) ‐37 (‐27 to ‐47) and (C) ‐39 (‐33 to ‐46). At one year: (I1) ‐40 (‐32 to ‐48), (I2) ‐43 (‐36 to ‐51) and (C) ‐41 (‐33 to ‐48) | |
| Notes | Only data from three of four groups are used for this review and are presented here | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central telephone randomisation, random permuted blocks/methods paragraph two |
| Allocation concealment (selection bias) | Unclear risk | Not described how/methods paragraph two |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | Exercise versus no exercise, booklet versus no booklet |
| Blinding (performance bias and detection bias) All outcomes ‐ care providers? | High risk | Exercise versus no exercise, booklet versus no booklet |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Participant was not blinded, patient reported outcomes |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | 3/37 = 8.1% dropouts rehab, 1/42 = 2.4% dropouts rehab + booklet, 4/40 = 10% usual care |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | Intention‐to‐treat (statistical analysis paragraph two)/imputation (paragraph three) |
| Selective reporting (reporting bias) | Low risk | ODI, VAS for pain (OM), reported in analysis of trial interventions + supplement tables |
| Similarity of baseline characteristics? | Low risk | Supplement Table 1 |
| Co‐interventions avoided or similar? | Low risk | Personal communication: Participants were asked if they instigated any treatments; this was minimal if any |
| Compliance acceptable? | High risk | Relatively high % non‐compliance |
| Timing outcome assessments similar? | Low risk | Methods last line: preop, six weeks, 3/6/9/12 months, tables |