Dr Paolo Buselli
Isituti Ospitalieri di Cremona Viale della Concordia
Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment: a mono-centre double-blind randomised controlled trial
Low back pain (LBP) affects more than 85% of adult population at least one time during the life. Health and social costs for LBP are increasing rapidly. Actually there is a general insufficient clinical evidence for endorsed treatments. Massage alone is unlikely to be effective while multidisciplinary methods seem to be the most promising approach.
This clinical study will investigate the effectiveness of new therapeutic medical device (SMATH System) in patients with subacute and chronic LBP. This device associates at the same time the mechanic, thermal and infrared energy released on the patient during automatic and perfectly reproducible treatment cycles. The study will compare results of SMATH treatments versus sham version of the same device which is a similar device able to reproduce on the patient the same sensations of the active SMATH System (vibration, pressure and warmth) but without active principles.
Cremona Hospital (Public Hospital Italy) Ethical Committee approved on 29/11/2010 ref:116/2010 LB
Mono-centre double-blind randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Low Back Pain
Automatic thermomechanic massage
SMATH System is a new automatic treatment device for subacute and chronic low back pain.
The treatment arm of the clinical study, plans to treat patients for four weeks with total 14 treatment sessions 45 minutes each. Four sessions will be done during the first and the second week, three treatment sessions will be done during the third and the fourth week.
During these sessions, patient will be treated by the machine with controlled and modulated release of mechanical, thermal and infrared energy. Medical Device simulates a real multidisciplinary treatment for low back pain because it is capable to assocciate at the same time automatically and with the maximum reproducibility the benefits of massage, moxibustion, thermal therapy, infrared, acupressure, bioresonance.
SMATH is full programmable in function of the spine region we'd like to treat (global spine, cervical area , lumbar area). The clinical study plans to treat patients with the following programs:
week 1 Session 1 Global spine treatment
Session 2 Lumbar treatment
Session 3 Lumbar treatment
Session 4 Global spine treatment
week 2 Same as week 1
week 3 Session 1 Global spine treatment
Session 2 and 3 Lumbar treatment
week 4 Same as week 3
Primary outcome measure
SMATH therapy effectiveness evaluation versus sham therapy meausered by RMDQ questionnaire
Secondary outcome measures
1. SMATH therapy effectiveness evaluation comparing RMDQ scores at T1 and QRMD at T4.
2. Pain feeling evaluation by visual analogue scale (VAS) questionnaires scores between T1 and T4.
3. Quality of Life evaluation by EQ-5D questionnaires between T1 and T4
4. Verify feasabilty of this RCT in terms of methodology, sample size, drop-out index, etc. in order to be a Pilot Study in the future clinical trials planning in conformity at the evidence based medecine needs
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Subjects with subacute and chronic low back pain-diagnosis in conformity with general scientific accepted criteria
2. Subjects age between 18 and 65 years
3. Subjects who sign informed consent
4. Subjects availability to fill questionnaires and to complete the study
5. Roland Morris Disability Questionnaire (RMDQ) score more or equal to 4 at trial (T1)
Target number of participants
36 subjects for SMATH arm and 36 for sham arm.
Participant exclusion criteria
2. Subject submitted at physical therapy during 15 days before T1.
3. Subjects submitted at pharmacological cortisone therapy during one month before T1, in this case a 30 days wash-out period will be requested
4. Subjects with active implantable devices
5. Subjects with infusion pumps
6. Subject with spine stabilisation device
7. Subjects with serious osteoporosis
8. Patients with soft or/and bone tissues acute infections
9. Subjects with acute cardiovascular deseases
10. Subjects with neoplastic deseases
11. Subjects with deep vein thrombosis during two months before T1
12. Subjects with rachis traumatic episodes during 3 months before T1
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Isituti Ospitalieri di Cremona Viale della Concordia, 1
Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)
Servizio di Fisioterapia ed U.O. Riabilitazione Specialistica Aziendale Azienda Ospedaliera "Istituti Ospitalieri di Cremona"
Istituti Ospitalieri di Cremona Viale della Concordia
+39 (0)372 405 314
Cremona Hospital (Italy)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21967800
Buselli P, Bosoni R, Busè G, Fasoli P, La Scala E, Mazzolari R, Zanetti F, Messina S, Effectiveness evaluation of an integrated automatic thermomechanic 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., Trials, 2011, 12, 216, doi: 10.1186/1745-6215-12-216.