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

Sponsor
Azienda Ospedaliera Universitaria Integrata Verona (Other)
Overall Status
Completed
CT.gov ID
NCT04651426
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled studProspective analysis in a 3-arm, randomized double-blind and placebo-controlled stud
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Oct 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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
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.
Active Comparator: F3 Patch

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
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.
Active Comparator: F4 Patch

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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. [The VAS scale results were compared, between the different patches, at day 0, 5, 8 and 14.]

    VAS scale (Visual Analogic Scale)

Secondary Outcome Measures

  1. Changes in the Range Of Motion (ROM) [The degrees of motion were absessed at day 0, day 8 and day 14]

    Degrees of flexion-extension and lateral bending of the patient.

Other Outcome Measures

  1. Changes in lifestyle. [The results of the RMDQ were absessed at day 0, day 8 and day 14]

    Evaluated on the median values of the RMDQ (Roland Morris Disability Questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliera Universitaria Integrata Verona Italy 37126

Sponsors and Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Principal Investigator: Matteo Ricci, Professor, Azienda Ospedaliera Universitaria Integrata Verona

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Matteo Ricci, Associate Professor at Department of Orthopaedic Surgery, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:
NCT04651426
Other Study ID Numbers:
  • 2128CESC
First Posted:
Dec 3, 2020
Last Update Posted:
Dec 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Matteo Ricci, Associate Professor at Department of Orthopaedic Surgery, Azienda Ospedaliera Universitaria Integrata Verona
non-medicated plaster, lumbar back pain, FIT Therapy
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Dec 3, 2020