| Methods |
Randomised |
| Participants |
98 participants, aged 18 to 60 years (mean age 39.2 (10.2) and 41.4 (9.9) years), male and female who underwent microdiscectomy after first sciatica 33.1 (67.6) to 38.7(69.8) months ago. Level of surgery: L2‐3: 1, L4‐5: 43, L5‐S1: 54 |
| Interventions |
Intervention (I: n = 51): USC Spine Exercise Programme + one back care education session. Back extensor strength and endurance training (using a variable‐angle Roman chair) and mat and therapeutic exercise training. 12 weeks of training, 3/wk, start four to six weeks postoperatively. Control (C: n = 47): a one‐hour back care education single session, four to six weeks postoperatively. |
| Outcomes |
Functional status (ODI) post‐treatment, mean change score and 95% CI: (I) ‐18.4 (‐22.5 to ‐14.3) and (C) ‐9.4 (‐13.0 to ‐5.8); significant difference P < 0.001 |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Blocked randomisation/method interventions paragraph one |
| Allocation concealment (selection bias) |
Low risk |
Personal communication: data management provided the random participant number to the study coordinator, who provided it to the blinded tester and interventionist |
| Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
Education versus education + exercise |
| Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
Education versus education + exercise |
| 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? |
High risk |
Dropouts 11.8%, 31.9% (Figure 2) |
| Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
ITT and as treated, but dropouts |
| Selective reporting (reporting bias) |
High risk |
Protocol: ODI/RDQ/VAS: 'administered immediately after sitting for 10 min, after 5MWT' (POM paragraph five, p 10). Reported: ODI, not pain (OM) ODI, not pain (results, Tables 2 + 3) |
| Similarity of baseline characteristics? |
Low risk |
Demographics, history, neurological symptoms, ODI Table1 |
| Co‐interventions avoided or similar? |
High risk |
Education: 19/32 to PT Figure 2, results, recruitment and retention paragraph one. Analysis post hoc: three groups |
| Compliance acceptable? |
High risk |
Cross‐over to PT or other group (results, recruitment and retention paragraph one) |
| Timing outcome assessments similar? |
Low risk |
Outcome measures paragraph one: four to six weeks postop/Abstract I&O: four to six weeks, 12 weeks later. Protocol: methods/design: pre/post interv outcome measures: pre/post interv, one year Q/VAS: every six months for four years |
