Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment

ISRCTN	ISRCTN08714168
DOI	https://doi.org/10.1186/ISRCTN08714168
Secondary identifying numbers	RCTSMATH1

Submission date: 14/02/2011
Registration date: 14/03/2011
Last edited: 18/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paolo Buselli
Scientific

Isituti Ospitalieri di Cremona Viale della Concordia, 1
Cremona
26100
Italy

Email	buselli.paolo@gmail.com

Study information

Study design	Mono-centre double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	RCTSMATH1
Study objectives	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.
Ethics approval(s)	Cremona Hospital (Public Hospital Italy) Ethical Committee approved on 29/11/2010 ref:116/2010 LB
Health condition(s) or problem(s) studied	Low Back Pain
Intervention	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
Intervention type	Other
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 study start date	03/01/2011
Completion date	06/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	36 subjects for SMATH arm and 36 for sham arm.
Key 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)
Key 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
Date of first enrolment	03/01/2011
Date of final enrolment	06/01/2012

Locations

Countries of recruitment

Italy

Study participating centre

Isituti Ospitalieri di Cremona Viale della Concordia, 1

Cremona
26100
Italy

Sponsor information

Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)
Hospital/treatment centre

Servizio di Fisioterapia ed U.O. Riabilitazione Specialistica Aziendale Azienda Ospedaliera "Istituti Ospitalieri di Cremona"
Istituti Ospitalieri di Cremona Viale della Concordia, 1
Cremona
26100
Italy

Phone	+39 (0)372 405 314
Email	buselli.paolo@gmail.com
"ROR"	https://ror.org/05w07vs91

Funders

Funder type

Hospital/treatment centre

Cremona Hospital (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	study protocol	04/10/2011		Yes	No

Editorial Notes

18/12/2020: Internal review.