| Methods |
Randomised |
| Participants |
93 patients, aged 17 to 63 years (mean 41, range 17 to 63, and 42, range 25 to 63) male and female, who had standard open lumbar discectomy (Sprengler technique) |
| Interventions |
Intervention (I, n = 47): six‐month progressive training, start six weeks postop, three sets of repetitions per exercise. Three phases: conditioning, hypertrophy and strength. Abdominals and lifting technique. Control (C: n = 46): surgical advice |
| Outcomes |
Participants in both groups improved significantly from the six‐week baseline measures to the 58‐week outcome measures. No significant between‐group differences. Functional status (ODI): at 58 weeks, mean score and SD (I) 11.66 (2.25) and (C) 12.00 (1.84); P = 0.90. Functional status (RMDQ): at 58 weeks, mean score and SD (I) 4.03 (.91) and (C) 4.53 (.74); P = 0.83. Differences in SF36 not significant: physical category (P = 0.19) and mental category (P = 0.85). Median time to return to work (I) 35 days and (C) 37 days (P = 0.65). Intervention started six weeks postsurgery |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated/methodology paragraph one |
| Allocation concealment (selection bias) |
Unclear risk |
Blinded assessor made use of computer‐generated randomisation |
| Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
Treatment versus no treatment |
| Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
Treatment versus 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? |
High risk |
One lost per group, two and seven did not complete 58‐week measures = 6.5% and 17%, 11 non‐completers intervention (results par 2 & 4) |
| Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
Dropouts, also Fig. 1 |
| Selective reporting (reporting bias) |
High risk |
No protocol, introduction last par: levels of pain; levels of function/methodology par 2: RMDQ, ODI, pain not mentioned/results: RMDQ, ODI no pain measures. Abstract mentions pain |
| Similarity of baseline characteristics? |
Low risk |
Age, gender, history, ODI similar table 2/neurological symptoms and pain not reported |
| Co‐interventions avoided or similar? |
Low risk |
GP eight‐two, therapist seven‐five non‐significant differences (results last paragraph) |
| Compliance acceptable? |
Low risk |
36 (77%) completed intervention, four partially (results paragraph three) |
| Timing outcome assessments similar? |
Low risk |
Study design paragraph one: six‐weeks, paragraph two: three years + annual questionnaire |
