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

NCT04651426 | Completed DMC

• 1 other identifier: 2128CESC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Back Pain

Keywords

non-medicated plaster, lumbar back pain, FIT Therapy

Outcome Measures

Primary Outcomes (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.

  VAS scale (Visual Analogic Scale)

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

Secondary Outcomes (1)

• Changes in the Range Of Motion (ROM)

  The degrees of motion were absessed at day 0, day 8 and day 14

Other Outcomes (1)

• Changes in lifestyle.

  The results of the RMDQ were absessed at day 0, day 8 and day 14

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

F3 Patch

ACTIVE COMPARATOR

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

F4 Patch

ACTIVE COMPARATOR

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

Interventions

The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 DEVICE

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.

F3 Patch; F4 Patch; Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic lumbar spine pain due to muscle contractures or over-use
• a signed informed consent
• patients 30 years of age or older.

You may not qualify if:

• infections
• neoplastic masses
• neuropathies
• metabolic disorders triggering the lumbar pain

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37126, Italy

Location

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MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Ricci, Professor

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at Department of Orthopaedic Surgery

Model Details: Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled stud

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: December 3, 2020
• Study Start: August 1, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 30, 2019
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)