Condition category
Musculoskeletal Diseases
Date applied
14/02/2011
Date assigned
14/03/2011
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paolo Buselli

ORCID ID

Contact details

Isituti Ospitalieri di Cremona Viale della Concordia
1
Cremona
26100
Italy
buselli.paolo@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RCTSMATH1

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

03/01/2011

Overall trial end date

06/01/2012

Reason abandoned

Eligibility

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36 subjects for SMATH arm and 36 for sham arm.

Participant 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

Recruitment start date

03/01/2011

Recruitment end date

06/01/2012

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)

Sponsor details

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
+39 (0)372 405 314
buselli.paolo@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cremona Hospital (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/21967800

Publication citations

  1. Study protocol

    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.

Additional files

Editorial Notes