Kole‐Snijders 1996.
| Methods | RCT; 'before first pretreatment measurement each patient was given a number written down on a card and folded up. An independent researcher blindly drew a card and assigned it to one of the three treatments.' | |
| Participants | 148 patients with CLBP for at least 6 months, aged 18‐65 years, observable pain behaviour, partner willing to participate, referred by general practitioner or specialist. Criteria to exclude patients included: illiteracy, pregnancy, involvement in litigation, alcohol or drug abuse, serious psychopathology, and specific medical pathology. | |
| Interventions | Behavioural treatment (I1): operant treatment (graded aerobic exercises, partner involvement) and cognitive treatment plus relaxation (decreasing distorted pain cognitions, increasing self‐expectations, imagery, applied relaxation) (N = 59). Behavioural treatment (I2): operant treatment plus group discussion, groups of 5 patients (N = 58). Reference treatment (R): waiting list control group (N = 31). |
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| Outcomes | Post‐treatment (I1) and (I2) had significantly less negative affect, higher activity tolerance, less pain behaviour, higher pain coping and higher pain control than (R). Post‐treatment (I1) had better pain coping and pain control than (I2). No significant differences at follow‐up on any outcome measure including costs and quality of life. Data in graphs. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | 'before first pretreatment measurement each patient was given a number written down on a card and folded up. An independent researcher blindly drew a card and assigned it to one of the three treatments.' |
| Allocation concealment? | Low risk | Adequate |
| Blinding? All outcomes ‐ patients? | Low risk | |
| Blinding? All outcomes ‐ providers? | High risk | |
| Blinding? All outcomes ‐ outcome assessors? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
| Free of selective reporting? | Low risk | |
| Similarity of baseline characteristics? | Low risk | |
| Co‐interventions avoided or similar? | Low risk | |
| Compliance acceptable? | High risk | |
| Timing outcome assessments similar? | Low risk | |