Nicholas 1991.
| Methods | RCT; 'randomly assigned'. | |
| Participants | 58 patients with chronic LBP, aged 21‐63 years, selected from patients referred from a pain clinic, and by specialists and general medical practitioners. Data available on 48 patients post‐treatment and 39 at follow‐up. | |
| Interventions | Behavioural treatment (I1): operant conditioning (Fordyce) and physiotherapy; one 2 hour and one 1.5 hour session / week / 5 weeks (N = 10). Behavioural treatment (I2): behavioural and physiotherapy and progressive muscle relaxation training; one 2 hour and one 1.5 hour session / week / 5 weeks (N = 9). Behavioural treatment (I3): cognitive treatment (coping strategies) and physiotherapy; one 2 hour and one 1.5 hour session / week / 5 weeks (N = 10). Behavioural treatment (I4): cognitive treatment and physiotherapy and progressive muscle relaxation training; one 2 hour and one 1.5 hour session / week / 5 weeks (N = 8). Reference treatment (R1): physiotherapy: information, exercises and handouts (one 2 hour and one 1.5 hour session / week / 5 weeks) (N = 11). Reference treatment (R2): physiotherapy (one 2 hour and one 1.5 hour session / week / 5 weeks) and attention (5 sessions) (N = 10). |
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| Outcomes | Posttreatment (I1), (I2), (I3) and (I4) significantly more improved on pain intensity (6‐point nominal scale), self‐rated functional status (SIP) and pain beliefs than (R1) and (R2), but no significant differences after 6 and 12 months. (I1) and (I2) significantly more improved post‐treatment on self‐rated SIP than (I3) and (I4). No other differences between behavioural treatments after 6 and 12 months on any of the outcome measures. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | 'randomly assigned' |
| Allocation concealment? | Unclear risk | Unclear |
| Blinding? All outcomes ‐ patients? | Unclear risk | Unclear from text |
| Blinding? All outcomes ‐ providers? | High risk | |
| Blinding? All outcomes ‐ outcome assessors? | High risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | |
| Free of selective reporting? | Low risk | |
| Similarity of baseline characteristics? | High risk | |
| Co‐interventions avoided or similar? | Low risk | |
| Compliance acceptable? | Low risk | |
| Timing outcome assessments similar? | Low risk | |