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

Not Applicable

Completed

• Conditions: ow Back Pain; Musculoskeletal Diseases; Low Back Pain

• Registration Number: ISRCTN08714168
• Lead Sponsor: Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-14
• Study Completion: 2012-01-06
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified