Coxhead 1981.
| Methods | RCT; factorial design | |
| Participants | Subjects: 334 patients with pain of sciatic distribution with or without LBP; 185 men and 149 women. Mean age 41.9, mean duration of symptoms 14.3 weeks. Exclusion criteria: specific LBP, patients undergone trunk, lower‐limb or spinal surgery within the previous three months and pregnant & postpartum women. | |
| Interventions | Treatment intervention:
1) Fabric made lumbar support, 4 weeks (n=124). No data on number of hours / day. Control interventions: 2) No lumbar support (n=168). |
|
| Outcomes | Pain, overall improvement and turn to work / normal activities. No differences after 4 weeks, 4 months and 16 months. | |
| Notes | 334 patients entered the study, 12 were later found ineligible. Of these 322 patients, 292 were assessed at 4 weeks. At 4 months 250 patients and at 16 months 258 patients were assessed. No data available regarding compliance. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | |
| Allocation concealment? | High risk | C ‐ Inadequate |
| Blinding? All outcomes ‐ patients? | High risk | |
| Blinding? All outcomes ‐ outcome assessor? | High risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | High risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
| Similarity of baseline characteristics? | Unclear risk | Unclear from text |
| Co‐interventions avoided or similar? | High risk | |
| Compliance acceptable? | High risk | |
| Timing outcome assessments similar? | Low risk | |