Exclusion criteria | Rationale |
---|---|
Pregnancy (real or suspected) and breast-feeding | These patients have a risk of some alteration due to the mechanical and thermal energy release |
Subjects who received physical therapy treatments in the 15 days preceding T1 | These treatments could influence the results of the study |
Subjects treated with cortisone in the month preceding T1 | This treatment could influence the results of the study |
Subjects implanted with pacemakers and ICDs (implantable cardioverter defibrillators); more generally, users of active implantable devices | In order to prevent possible electromagnetic interference between SMATH® and the implantable device, which is potentially dangerous for the patient (cautelative criteria) |
Subjects with medullar stimulators and infusion pumps with recent or ongoing DVT (deep venous thrombosis) | To prevent possible electromagnetic and mechanical interference between SMATH® and the implantable device, which is potentially dangerous for the patient (cautelative criteria) |
Subjects with spine stabilization devices | These treatments could influence the results of the study |
Subjects with serious osteoporosis associated with bone fracture risk | Mechanical energy release on these patients could increase bone fracture risk |
Subjects with logically soft or acute infection of bone tissues | Thermal and mechanical energy release could increase infection diffusion |
Subjects with acute cardiovascular disease | These patients need to be submitted to specific clinical evaluation before being treated for LBP |
Subjects with neoplastic disease | These patients need to be submitted to specific clinical evaluation before being treated for LBP |
Subjects with systemic rheumatic disease | These patients need to be submitted to specific clinical evaluation before being treated for LBP. |
Subjects with traumatic spinal episodes the 3 months preceding T1 | Mechanical energy release on these patients could be dangerous. |