%0 Journal Article
%T Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH£¿ system) in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial
%A Paolo Buselli
%A Roberto Bosoni
%A Gabriella Bus¨¨
%A Paola Fasoli
%A Elide La Scala
%A Rita Mazzolari
%A Federica Zanetti
%A Sara Messina
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-216
%X This paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH£¿ versus sham therapy (medical device without active principles) determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ) scores after 4 weeks of treatment (end of treatment). Major secondary outcome will be effectiveness of SMATH£¿ determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm). The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010.Compared to other medical specialties, physical and rehabilitation medicine (PRM) has not yet received the deserved recognition from clinicians and researchers in the scientific community, especially for medical devices. The best way to change this disadvantage is through well-conducted clinical research in sham-controlled randomized trials. Sham treatment groups are essential for improving the level of evidence-based practice in PRM. The present trial will counter the general lack of evidence concerning medical devices used in LBP therapy.ISRCTN: ISRCTN08714168Low back pain (LBP) is a major health problem in modern society; 70-85% of the population will experience LBP at some time in their lives [1]. Each year, 5-10% of the workforce misses work due to LBP, the majority for less than 7 days [2]. Almost 10% of all patients are at risk of developing chronic pain and disability, accounting for more than 90% of the costs associated with back-related disability [3]. LBP incurs substantial treatment and productivity costs worldwide [4]. Healthcare and social costs for LB
%U http://www.trialsjournal.com/content/12/1/216