Million 1981.
Methods | RCT | |
Participants | Subjects: 19 patients, 13 women and 6 men. Mean age 47.1. Inclusion criteria: 1) over 18 years of age, 2) suffering from chronic non‐specific LBP > 6 months, 3) not responding to any form of treatment. | |
Interventions | Treatment intervention:
1) Corset and lumbar support (n=9). Support is of rigid material. Corset use during the day, 8 weeks. Control intervention: 2) Corset (n=10), lumbosacral corset use during the day, 8 weeks. |
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Outcomes | Subjective and objective index. Rigid support better subjective index after 4 and 8 weeks. | |
Notes | The subjective index is an overall measurement of the severity of symptoms and of the interference of these symptoms with normal activities. The objective index is an overall measurement of the straight leg raising and of spinal movements. No data on compliance. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | |
Allocation concealment? | Low risk | A ‐ Adequate |
Blinding? All outcomes ‐ patients? | Low risk | |
Blinding? All outcomes ‐ outcome assessor? | High risk | |
Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
Similarity of baseline characteristics? | High risk | |
Co‐interventions avoided or similar? | High risk | |
Compliance acceptable? | High risk | No data on compliance. |
Timing outcome assessments similar? | Low risk |