| Methods |
Randomised by drawing of lots |
| Participants |
96 patients (49 men, 47 women) who had undergone first‐time discectomy for lumbar disc protrusion, aged 18 to 70 years. Interventions start five weeks after surgery |
| Interventions |
Both groups: (in classes of two to six patients) in total 14 hours, including five instruction and ergonomics sessions. (I) Intensive exercises: (start session hot packs and five heavy exercises: (1) leg lifting, (2) trunk lifting (one and two from 45 degrees flexion to 0 degrees), (3) abdominal exercise, (4) leg abduction, (5) leg adduction (10 repetitions each). End of session: six minutes submaximal bicycle training and five stretching exercises. Six one‐hour sessions, twice a week; next three weeks, six 30‐minute sessions in water (same principles, no limits to range of motion) (including rotatory elements). Pain was no reason for stopping. (C) 15 mild general mobilisation exercises, 10 repetitions each, programme started with six 30‐minute sessions (twice a week) in water. Next three weeks, same principles in gymnasium. If pain occurred: stop. |
| Outcomes |
Overall improvement at 52 weeks: (I) 76% (C) 70% "very satisfactory" or "satisfactory, little discomfort". Not significantly different. Medians: pretreatment post‐treatment: 6, 12, 26, 52 weeks: on low back pain scale 0 to 30: (I) 5.5, 2.0, 1.8, 5.2, 3.7; (C) 7.1, 3.4, 2.4, 5.5, 6.5, no significant differences; on leg pain scale (0 to 30): (I) 4.5, 2.2, 3.0, 3.0, 0.8, (C) 4.8, 3.2, 3.0, 5.0, 2.2; no significant differences; on disability scale (0 to 30): (I) 10.8, 4.5, 4.4, 4.0, 4.2, (C) 11.5, 6.1, 4.3, 6.5, 6.0, statistically significant at 26 weeks. Physical impairment scale (0 to 40): pretreatment, post‐treatment and 6 weeks: (I) 16.2, 11.8, 12.5, (C) 16.8, 11.8, 12.3, no significant difference. All scales are subscales of Low‐Back Pain Rating Scale (high scores denote poor outcome). Days off work in (I) significantly less on 26 and 52 weeks. Number of participants not returned to work: (I) 14.3% (C) 30%: statistically significant. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised by drawing of lots |
| Allocation concealment (selection bias) |
Low risk |
Personal communication |
| Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
High‐ versus low‐intensity programme |
| Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
High‐ versus low‐intensity programme |
| Blinding (performance bias and detection bias)
All outcomes ‐ outcome assessors? |
High risk |
Patient reported |
| Incomplete outcome data (attrition bias)
All outcomes ‐ drop‐outs? |
Unclear risk |
Size of intervention and control groups unclear |
| Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
Dropouts |
| Selective reporting (reporting bias) |
Low risk |
Pain and function in methods (last paragraph) and reported in results, Table 3 |
| Similarity of baseline characteristics? |
Low risk |
Results paragraph two |
| Co‐interventions avoided or similar? |
Unclear risk |
Unclear from text |
| Compliance acceptable? |
Low risk |
Personal communication |
| Timing outcome assessments similar? |
Low risk |
6, 26, 52 weeks |
