Monticone 2013.
| Methods | RCT conducted in Italy | |
| Participants | Patients referred to a rehabilitation centre with LBP >3 months and >18 years. 90 patients randomised, 57.8% female, average age 49.8 years, mean duration of pain 25.8 months | |
| Interventions |
MBR (CBT + Physical): 5 weeks program plus 1 year reinforcement. 1 individual CBT session/week of 60 minutes, then 1 session/month for 12 months. Sessions included fear avoidance beliefs, catastrophising, inappropriate beliefs, negative thoughts, transferring attention, graded exposure, motivation, goal‐setting. Physical program, individually delivered: active and passive mobilisations, stretching, strengthening, postural/motor control exercises. Up to 10 sessions, 2 sessions/week for 5 weeks, plus home exercise program Physical (Control): physical program, individually delivered, active and passive mobilisations, stretching, strengthening, postural/motor control exercises. Up to 10 sessions, 2 sessions/week for 5 weeks, plus home exercise program |
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| Outcomes | Pain (NRS), Disability (RMDQ), General Health (SF‐36), Fear Avoidance (TSK) Follow‐ups: ST (post‐treatment), LT (1 and 2 years) | |
| Notes | Subgroup analyses: Low intensity intervention, High baseline symptom intensity (>60% of maximum scale score) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | pg.2 Randomization. "randomized the patients to one of the 2 treatment programs using a list previously generated by a biostatistician (SAS PROC PLAN)" |
| Allocation concealment (selection bias) | Low risk | pg.2 Randomization. "...delivered to the Principal Investigator with blinded treatment codes" |
| Blinding of participants | High risk | Not possible |
| Blinding of clinicians | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not possible; patient reported outcome |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | pg.4 Participant flow. "No patients dropped out during the course of the study" |
| Intention to treat analysis | Low risk | Flow chart. No dropout, all patients treated as per protocol |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Comparability of groups at baseline | Low risk | Table 3. Groups comparable on relevant demographic and clinical variables |
| Compliance | Unclear risk | Not stated |
| Cointerventions | Unclear risk | Not stated |
| Timing of assessment | Low risk | pg.3 Outcome measures. "questionnaires were completed before treatment (T1), 5 weeks later (at the end of the instructive phase, T2), and then 12 months (post‐treatment analysis, T3) and 24 months after the end of the instructive phase (1‐year follow‐up, T4)" |