Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.

Study Overview
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Brief Summary
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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).

Detailed Description
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First and foremost, the investigators obtained the ethical committee approval, then 54 patients were enrolled since May 2019 to November 2019, at the AOUI (Azienda Ospedaliera Universitaria Integrata) Verona. Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled study was performed to assess the effect of FIT Therapy patches on the chronic lumbar spine pain and on the ROM. 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. The intrinsic properties of the FIT technology are due to the mix of titanium dioxides that reflect the FIR emitted by the human body. Three different plasters were used: a placebo (without any biomineral, therefore with no reflectance ability); an F3 patch and an F4 one, characterized by different power of action (F4 has a broader spectrum of refrigency than F3). The 3 plasters presented no difference in size, color and shape. Patients were subdivided in 3 randomized groups.The Visual Analogic Scale (VAS) and the Roland Morris Disability Questionnaire (RMDQ) were used. The Range of Motion (ROM) evaluation consisted of flexion and extension, lateral bending and rotation of the lumbar spine. The trial consisted of a total of 14 days for each patient. At day 0, during the first clinical encounter, patients were enrolled by signing an informed consent. Still during the encounter, the lumbar spine ROM was measured, the VAS and the RMDQ administered. Only after all these necessary steps the first patch was applied. Every patient was given a RMDQ and a journal, which had to be updated daily, and at the same time every day, with the pain level experienced and any adverse effect to the FIT Therapy patch. At day 5 the patch was self-removed and the RMDQ given during the first encounter filled. The second clinical encounter was at day 8. The patients' ROM and VAS were tested for the second time and a new FIT Therapy patch was applied. At day 13 the FIT Therapy patch was dismissed and a second RMDQ filled at home. The last clinical encounter was held at day 14 and once again all 54 patients' ROM and VAS were assessed. Finally, the daily journal was collected, and patients were asked if any other pain medication was self-administered during the entirety of the tests.

Official Title
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Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.

Conditions
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Back Pain

Intervention / Treatment
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* Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:: chronic lumbar spine pain due to muscle contractures or over-use a signed informed consent patients 30 years of age or older. Exclusion Criteria: infections neoplastic masses neuropathies metabolic disorders triggering the lumbar pain

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled stud
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The Placebo is a Patch identical to the F3 and F4 patches in aesthetics but without any biomineral, therefore with no reflectance ability. | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1<br>* 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.<br>|
| Active Comparator: F3 Patch<br>The F3 is a patch made of 100% polypropylene non-woven fabric, an acrylic adhesive mass and a mix of titanium dioxide printed on with a refringency spectrum 2 m x kg | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1<br>* 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.<br>|
| Active Comparator: F4 Patch<br>The F4 is a patch made of 100% polypropylene non-woven fabric, an acrylic adhesive mass and a mix of titanium dioxide printed on with a refringency spectrum of 4 m x kg | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes induced by the different types of FIT Therapy patches (placebo, F3 and F4), in the pain level due to lower back pain, measured on the VAS scale. | VAS scale (Visual Analogic Scale) | The VAS scale results were compared, between the different patches, at day 0, 5, 8 and 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Range Of Motion (ROM) | Degrees of flexion-extension and lateral bending of the patient. | The degrees of motion were absessed at day 0, day 8 and day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-medicated plaster, lumbar back pain, FIT Therapy