Methods |
Randomised |
Participants |
75 patients, mean age 46.09 years, male and female, with primarily leg pain not responding to conservative treatment, who had undergone discectomy |
Interventions |
Intervention (I: n = 35): advice, lumbar extension exercise handout, home exercise for six weeks, then intensive training for 12 weeks. MedX system, which restricts hip and pelvic motion Control (C: n = 40): advice, lumbar extension exercise handout, six weeks of home‐based exercise, continued for another 12 weeks |
Outcomes |
Pain intensity (VAS): largely decreased in both exercise and control groups after 12 weeks of extension exercise. (I) 2.51 and (C) 4.3 (P < 0.05) post‐treatment, (I) 1.5 and (C) 1.3 at one year (no significant difference). Functional status (ODI): Postoperative ODI scores were improved compared with preoperative ODI scores (I) 24.6 and (C) 30.6 post‐treatment (no significant difference). Return to work: More than 92% returned to work within six months after surgery. (I) 87% and (C) 24% returned within four months |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Participants were randomly assigned/participants and methods paragraph one |
Allocation concealment (selection bias) |
Unclear risk |
Participants were randomly assigned/participants and methods paragraph one |
Blinding (performance bias and detection bias)
All outcomes ‐ patients? |
High risk |
Home based versus clinic based |
Blinding (performance bias and detection bias)
All outcomes ‐ care providers? |
High risk |
Home based versus clinic based |
Blinding (performance bias and detection bias)
All outcomes ‐ outcome assessors? |
High risk |
Participants were not blinded, patient reported outcomes |
Incomplete outcome data (attrition bias)
All outcomes ‐ drop‐outs? |
High risk |
Five of 40 IG dropout (patient and methods paragraph two and Table 1), less than 20% but not similar in groups |
Incomplete outcome data (attrition bias)
All outcomes ‐ ITT analysis? |
High risk |
Five dropouts |
Selective reporting (reporting bias) |
Low risk |
Pain VAS, function ODI |
Similarity of baseline characteristics? |
Unclear risk |
Only age reported, 51.05 versus 42.02, = significantly different |
Co‐interventions avoided or similar? |
Unclear risk |
Not described |
Compliance acceptable? |
Unclear risk |
Not described |
Timing outcome assessments similar? |
Low risk |
Patients and methods paragraph four: baseline six weeks, paragraph six: follow‐up at 12 weeks, one year |