Controlled trial of a back support ('Lumbotrain') in patients with non-specific low back pain.

A randomized, controlled, parallel-group clinical trial was carried out in general practice to assess the clinical efficacy of a new back support ('Lumbotrain') compared with 'standard therapy' of advice on rest and lifestyle in the treatment of patients with non-specific low back pain. A total of 216 patients entered this study (111 'Lumbotrain' group, 105 control group). All patients were allowed to take 1 g paracetamol up to 4-times daily if necessary for control of pain. Self-assessments were made daily by patients, over a period of 21 days, of pain levels at rest, on activity, at night, and limitation of activity using visual analogue scales. Details were also recorded of their ability to work or not, and the number of doses of paracetamol taken. At the end of the study period, patients assessed their overall response to treatment and those in the 'Lumbotrain' group were questioned on the comfort and ease of use of the back support. A clinical examination was carried out by the doctor at the start and end of the study period and an assessment made of the total range of active and passive back movement. Analysis of the daily diary records showed there were progressive, significant reductions in mean scores for all the pain and activity criteria in both groups and these were significantly greater in the 'Lumbotrain' group from Day 7 onwards. The times taken for reduction of symptom scores to 10% of initial values were significantly less in the 'Lumbotrain' group, such a degree of recovery occurring 2 to 4 days more rapidly than in the control group. A significantly higher proportion of patients in the 'Lumbotrain' group became able to work normally. After 3 weeks, 85% of patients in the 'Lumbotrain' group could work normally, as compared with 67% in the control group (p less than 0.02). Total analgesic consumption during the trial was significantly lower (p less than 0.0001) in the 'Lumbotrain' group (median 24.5 doses) than in the control group (median 51 doses). Overall clinical assessment scores were significantly superior in the 'Lumbotrain' group (p less than 0.002). Improvement was seen in 106 (95%) of 111 patients in the 'Lumbotrain' group, as compared with 79 (77%) of 103 of those in the control group (p less than 0.0002).(ABSTRACT TRUNCATED AT 400 WORDS)

RCT Entities:   Population Interventions Outcomes