At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.
In Brief
A clinical study evaluating The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 for Back Pain. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The investigator assessed 54 patients with chronic lumbar back pain treated with FIT Therapy (far infrared technology) patch. The criteria for inclusion were chronic lumbar back pain due to overstress or to contracture and patients over 30 years old. Patients with tumors, infections, neurological and metabolic diseases were excluded. Three different types of FIT Therapy patches (F4, F3 and the placebo) were used according to the different power of action. The patches were self-removed after 5 days. At day 8 new ones were applied for other five days and at day 14 patients were dismissed. Every single patient was assessed during the study using the VAS pain scale, the Roland Morris questionnaire for quality of life and the range of motion (ROM).
Study Details
Timeline
Interventions
The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 which mechanism of action is through the ability of biominerals to reflect the far infrared radiation (FIR). Normally the human body temperature would dissipate regular far infrared radiations but, thanks to the FIT Therapy (Far Infrared Technology), these waves are reflected and allowed to reach deeper areas in the human body (wavelength spectrum is 4-21 µm with a denser concentration around 11 µm). Every FIT device act as a mirror and they are able to induce an antalgic effect simply thanks to this biophysical process, therefore without releasing any active ingredient or creating a thermic shock. The plasters are made of 100% polypropylene non-woven fabric, an acrylic adhesive mass and a mix of titanium dioxide printed on. This particular mix in powder form is characterized by particles sizes above 100 nm.