Hagen 2003.
Methods | Randomised, controlled, concealed allocation, and intention‐to‐treat basis. | |
Participants | Patients sick‐listed for at least 8 weeks for LBP, mean age 41 years. Total 437 participants were randomised into: Intervention group, N = 237; Control group, N = 220; Inclusion criteria: age 18 to 60 years, a sick leave of 8 to 12 weeks. Exclusion criteria: pregnancy, recent low‐back trauma, and concurrent disorders. |
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Interventions | Exercise group: Subjects were advised and instructed individually by physiotherapists in how to train and stretch at home, coping with daily activities at home and work, and how to resume normal activities. Control group: Subjects were treated within the primary health care. |
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Outcomes | Number of subjects with recurrent LBP, and days of sick leaves due to LBP. | |
Notes | 510 people were randomised. The study analysis is based on the following distribution: Intervention, N = 237; Control, N = 220; It appears that 53 participants dropped out after being randomised, which is 10.4% of the population, but before the beginning of the intervention. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | |
Allocation concealment? | Low risk | Adequate. |
Blinding? All outcomes | High risk | Patients and providers not blinded; unclear if outcome assessors were blinded: 'data from the National Insurance Office'. |
Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
Similarity of baseline characteristics? | Low risk | |
Co‐interventions avoided or similar? | Low risk | There were no significant differences between the intervention and the control group in the use of analgesics, contacting the physician and relaxation as coping strategies to reduce LBP. |
Compliance acceptable? | Low risk | |
Timing of outcome assessments similar? | Low risk |