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. 2008 Apr 23;2008(2):CD001823. doi: 10.1002/14651858.CD001823.pub3

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