Schweikert 2006.
| Methods | RCT; 'randomisation performed... using Rancode Professional 3.6' | |
| Participants | 409 patients with non‐specific LBP for at least 6 months, pre‐screened by pension insurance administration. Exclusion criteria were severe co‐morbidities, an indication of severe spinal pathology such as rheumatoid arthritis, osteoporosis, fibromyalgia, oncologic diseases, or radiologically proven intervertebral disc rupture. Further, patients were excluded if they had filed an application for early retirement or if they were unemployed for more than 12 months. | |
| Interventions | Behavioural treatment (I): cognitive‐behavioural pain management program (relaxation, distraction of attention, cognitive reappraisal of pain and stress, coping strategies) in 6 group sessions, in addition to standard inpatient rehabilitation (N = 200). Reference treatment (R): standard inpatient rehabilitation (conventional 3‐week inpatient rehabilitation program consisting of physiotherapy in small groups, massage, electrotherapeutic measures, education, twice‐daily exercise program) (N = 209). |
|
| Outcomes | Post‐treatment, none of the behavioral, pain, or disability outcome measures displayed significant differences between (I) and (R). After 6 months, there were no significant differences between groups in quality‐adjusted life‐years gained or in direct medical or non‐medical costs. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | 'randomisation performed... using Rancode Professional 3.6' |
| Allocation concealment? | Low risk | Adequate |
| Blinding? All outcomes ‐ patients? | High risk | "Blinding of patients, clinic physicians, and the psychologists administering the treatment was not possible due to the nature of the intervention." |
| Blinding? All outcomes ‐ providers? | High risk | as above |
| Blinding? All outcomes ‐ outcome assessors? | High risk | as above |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | High risk | Figure 1 |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | Table 2, only analysed patients who completed treatment |
| Free of selective reporting? | Low risk | all specified outcomes are reported |
| Similarity of baseline characteristics? | Low risk | Table 1 |
| Co‐interventions avoided or similar? | Unclear risk | Unclear from text |
| Compliance acceptable? | Unclear risk | Unclear from text |
| Timing outcome assessments similar? | Low risk | Figure 1 |