| Methods |
Randomised, three groups |
| Participants |
120 patients, male and female, aged 41.8 ± 10.4; 42.3 ± 9.8; 39.8 ± 10.5. Standard laminectomy and (micro)discectomy after mean 5.8 to 6.5 weeks of complaints. Level of surgery: L3–L4: 7; L4–L5: 45; L5–S1: 57 |
| Interventions |
Intervention (PT: n = 40): physiotherapy‐based rehabilitation start one week postoperatively, 12 weeks, 20 sessions of 30 minutes, strength, stretching, ergonomics, improvement in general mobility of the spine, improving muscle coordination and automatic muscle response time. Sham therapy (S: n = 40): 20 sessions “sham” neck massage of 30 minutes’ duration each. Control (C: n = 40): no treatment |
| Outcomes |
Post‐treatment scores (mean, 95% CI) on functional status (LBPRS) were (PT) ‐15.98 (‐18.02 to ‐13.9), (S) ‐13.23 (‐15.35 to ‐11.1) and (C) ‐12.15 (‐14.59 to ‐9.71). Significant difference PT versus C: ‐3.82 (‐6.96 to ‐.69), P = 0.017. No difference PT versus S: ‐2.75 (‐5.65 to 0.15), P = .063. At one year, scores were (PT) ‐13.83 (‐16.71 to ‐10.94), (S) ‐13.2 (‐15.66 to ‐10.74) and (C) ‐11.37 (‐14.16 to ‐8.58). No significant differences: PT versus C: ‐2.45 (‐6.41 to 1.50), P = 0.220 and PT versus S: ‐.63 (‐4.36 to 3.11), P = 0.74. Post‐treatment scores (mean, 95% CI) on pain (LBPRS) were (PT) ‐4.1 (‐6.59 to ‐1.61), (S) ‐2.91 (‐6.53 to 0.7) and (C) 0.82 (‐2.8 to 4.43). Significant difference between PT and C: ‐4.92 (‐9.23 to ‐.60), P = 0.026. No difference between PT and S: ‐1.19 (‐5.51 to 3.14), P = 0.59. At one year, scores were (PT) ‐2.05 (‐6.27 to 2.17), (S) ‐3.81 (‐8.18 to 0.56) and (C) 1.2 (‐3.29 to 5.68). No differences between PT and C: ‐3.24 (‐9.31 to 2.82), P = 0.29 and PT versus S: 1.77 (‐4.21 to 7.74), P = 0.56. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Blocks |
| Allocation concealment (selection bias) |
Low risk |
Sequentially numbered sealed opaque envelopes/randomisation and blinding |
| Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
PT, massage, no treatment |
| Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
PT, massage, no treatment |
| Blinding (performance bias and detection bias)
All outcomes ‐ outcome assessors? |
High risk |
Participant not blinded, patient reported outcomes |
| Incomplete outcome data (attrition bias)
All outcomes ‐ drop‐outs? |
Low risk |
One PT, two sham, six control dropouts, later lost four, six, two/12.5%, 20%, 20% (results/Figure 1) |
| Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
ITT (statistical analysis paragraph two), but dropouts |
| Selective reporting (reporting bias) |
Low risk |
No protocol found, pain, disability: LBP‐RS outcome measures paragraph two. Results presented Table 4 |
| Similarity of baseline characteristics? |
Low risk |
Demographics, history, lasegue Table 2, LBPRS Table 3 + 4 |
| Co‐interventions avoided or similar? |
Unclear risk |
Personal communication: type/frequency of medication: no difference at the end of therapy. Main comparison of PT versus no therapy: P value 0.8 at three months Other interventions not reported |
| Compliance acceptable? |
Low risk |
Personal communication: The weekly amount of home exercise was about 20 minutes and did not differ between groups: Results of main comparison (PT vs no therapy): P value 0.8 at three months and 0.4 at 1.5 years |
| Timing outcome assessments similar? |
Low risk |
Outcome measures paragraph one, Tables 3 and 4 |
