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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08714168

Enrollment

Registered

2011-03-14

Start date

2011-01-03

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain Musculoskeletal Diseases Low Back Pain

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, plan

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
SMATH therapy effectiveness evaluation versus sham therapy meausered by RMDQ questionnaire	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026