Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain.
To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost.
There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device.
This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments.
One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 ± 4.4 vs. de 6.1 ± 4.7;P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 ± 21.4 vs. 32.0 ± 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG;P = 0.029).
Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.
This randomized, multicentric, and controlled study with 197 subacute patients with low back pain (2 groups, 1 treated with a lumbar belt and 1 control group) shows that lumbar belt wearing is consequent to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.
From *Service de Médecine Physique et Réadaptation, Université Jean Monnet, Hôpital Bellevue, Saint Etienne, France; †Centre Hospitalier de Saint Etienne, Saint-Etienne, France; ‡Service de Médecine Physique et Réadaptation, Hôtel-Dieu, Paris, France; §Aramis Consultants, Neuilly sur Seine, France; and ¶Service de Rééducation Neuro-Orthopédique Hôpital Rothschild APHP, Paris, France.
Acknowledgment date: January 4, 2008. First revision date: July 13, 2008. Second revision date: August 27, 2008. Acceptance date: August 27, 2008.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Paul Calmels, PhD, MD, Service de Médecine Physique et Réadaptation, CHU Saint-Etienne, Hôpital Bellevue, 42055 Saint Etienne Cedex 2, France. E-mail: email@example.com