Hsieh 1992.
Methods | RCT | |
Participants | Subjects: 164 patients, 62 women and 102 men with non‐specific LBP and no sciatica. Median age 32 and mean duration of complaints between 3 weeks and 6 months. Inclusion criteria: 1) age 18‐55 years, 2) LBP between 3 weeks and 6 months duration, 3) good health. | |
Interventions | Treatment intervention:
1) Corset (n=29),
lumbosacral canvas corset with metal stays in the back. Corset use during waking hours, 3 weeks. Control interventions: 2) Spinal manipulation (n=70), 3 times / week. 3) Soft tissue massage (n=37), 3 times / week. 4) TMS (n=28), unit should be worn for 8 hours / day. |
|
Outcomes | Pain, functional status. No differences in pain. Functional status only after 4 weeks better compared to massage, not to manipulation and TMS. | |
Notes | 88% of the original patients completed the assessments at baseline and at 4 weeks. Data of RDQ and revised Oswestry are reported by Hsieh (1992) for a subgroup of 83 patients from the study population of Pope. Compliance: 65% wore the belt more than 7 hours a day during the intervention period. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | |
Allocation concealment? | Low risk | A ‐ Adequate |
Blinding? All outcomes ‐ patients? | High risk | |
Blinding? All outcomes ‐ outcome assessor? | Low risk | |
Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | High risk | |
Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | |
Similarity of baseline characteristics? | Low risk | |
Co‐interventions avoided or similar? | Low risk | |
Compliance acceptable? | Low risk | Compliance: 65% wore the belt more than 7 hours a day during the intervention period. |
Timing outcome assessments similar? | Low risk |