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Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment
ISRCTN ISRCTN08714168
DOI 10.1186/ISRCTN08714168
ClinicalTrials.gov identifier
EudraCT number
Public title Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment
Scientific title 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
Acronym RCTSMATH1
Serial number at source RCTSMATH1
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Cremona Hospital (Public Hospital Italy) Ethical Committee approved on 29/11/2010 ref:116/2010 LB
Study design Mono-centre double-blind randomised controlled trial
Countries of recruitment Italy
Disease/condition/study domain Low Back Pain
Participants - 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)
Participants - exclusion criteria 1. Pregnancy
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
Anticipated start date 03/01/2011
Anticipated end date 06/01/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 36 subjects for SMATH arm and 36 for sham arm.
Interventions 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(s) SMATH therapy effectiveness evaluation versus sham therapy meausered by RMDQ questionnaire
Secondary outcome measure(s) 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
Sources of funding Cremona Hospital (Italy)
Trial website
Publications 1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21967800
Contact name Dr  Paolo  Buselli
  Address Isituti Ospitalieri di Cremona Viale della Concordia, 1
  City/town Cremona
  Zip/Postcode 26100
  Country Italy
  Email buselli.paolo@gmail.com
Sponsor Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)
  Address Servizio di Fisioterapia ed U.O. Riabilitazione Specialistica Aziendale Azienda Ospedaliera "Istituti Ospitalieri di Cremona"
Istituti Ospitalieri di Cremona Viale della Concordia, 1
  City/town Cremona
  Zip/Postcode 26100
  Country Italy
  Tel +39 (0)372 405 314
  Fax +39 (0)372 405 750
  Email buselli.paolo@gmail.com
Date applied 14/02/2011
Last edited 11/01/2012
Date ISRCTN assigned 14/03/2011
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