Back PainCERFITNCT04651426
Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.
A study testing The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 in people with Back Pain, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic lumbar spine pain due to muscle contractures or over-use
- a signed informed consent
- patients 30 years of age or older.
Who cannot join
- infections
- neoplastic masses
- neuropathies
- metabolic disorders triggering the lumbar pain
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Back Pain
- Being tested
- The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1
- Keywords
- non-medicated plaster, lumbar back pain, FIT Therapy
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Degrees of flexion-extension and lateral bending of the patient.
Measured: The degrees of motion were absessed at day 0, day 8 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Aug 2019
- Primary completion15 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled stud
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Ricci, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Matteo Ricci, Professor, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651426
- Sponsor's protocol ID
- 2128CESC
- Acronym
- CERFIT
- Status last verified
- Nov 2020
- First submitted
- 17 Oct 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong CH, Lin LC, Lee HH, Liu CF. The analgesic effect of thermal therapy after total knee arthroplasty. J Altern Complement Med. 2012 Feb;18(2):175-9. doi: 10.1089/acm.2010.0815.
PubMed 22339105Lee CH, Roh JW, Lim CY, Hong JH, Lee JK, Min EG. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of a far infrared-emitting sericite belt in patients with primary dysmenorrhea. Complement Ther Med. 2011 Aug;19(4):187-93. doi: 10.1016/j.ctim.2011.06.004. Epub 2011 Jul 16.
PubMed 21827932Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
PubMed 27408698Bagnato GL, Miceli G, Atteritano M, Marino N, Bagnato GF. Far infrared emitting plaster in knee osteoarthritis: a single blinded, randomised clinical trial. Reumatismo. 2012 Dec 20;64(6):388-94. doi: 10.4081/reumatismo.2012.388.
PubMed 23285483Lai CH, Leung TK, Peng CW, Chang KH, Lai MJ, Lai WF, Chen SC. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study. J Altern Complement Med. 2014 Feb;20(2):123-9. doi: 10.1089/acm.2013.0122. Epub 2013 Oct 23.
PubMed 24152215Ricci M, Micheloni GM, Perusi F, Corbo VR, Vecchini E, Magnan B. Use of a non-medicated plaster in shoulder tendinopathies. Acta Biomed. 2016 Apr 15;87 Suppl 1:90-4.
PubMed 27104326Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Ma K, Zhuang ZG, Wang L, Liu XG, Lu LJ, Yang XQ, Lu Y, Fu ZJ, Song T, Huang D, Liu H, Huang YQ, Peng BG, Liu YQ. The Chinese Association for the Study of Pain (CASP): Consensus on the Assessment and Management of Chronic Nonspecific Low Back Pain. Pain Res Manag. 2019 Aug 15;2019:8957847. doi: 10.1155/2019/8957847. eCollection 2019.
PubMed 31511784Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
PubMed 30252425Santos LF, Correia IJ, Silva AS, Mano JF. Biomaterials for drug delivery patches. Eur J Pharm Sci. 2018 Jun 15;118:49-66. doi: 10.1016/j.ejps.2018.03.020. Epub 2018 Mar 20.
PubMed 29572160Pastore MN, Kalia YN, Horstmann M, Roberts MS. Transdermal patches: history, development and pharmacology. Br J Pharmacol. 2015 May;172(9):2179-209. doi: 10.1111/bph.13059. Epub 2015 Mar 18.
PubMed 25560046Miller K. Transdermal patches: past, present and future. Ther Deliv. 2015;6(6):639-41. doi: 10.4155/tde.15.16. No abstract available.
PubMed 26149780Tsai SR, Hamblin MR. Biological effects and medical applications of infrared radiation. J Photochem Photobiol B. 2017 May;170:197-207. doi: 10.1016/j.jphotobiol.2017.04.014. Epub 2017 Apr 13.
PubMed 28441605Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015.
PubMed 26793049Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.
PubMed 23833705
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Non-medicated Plaster in Chronic Lumbar Back Pain.
- ClinicalTrials.gov ID
- NCT04651426
- Acronym / sponsor ID
- CERFIT / 2128CESC
- Conditions
- Back Pain
- Keywords
- non-medicated plaster, lumbar back pain, FIT Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective analysis in a 3-arm, randomized double-blind and placebo-controlled stud
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1The Placebo is a Patch identical to the F3 and F4 patches in aesthetics but without any biomineral, therefore with no reflectance ability. |
| F3 Patch | Active comparator | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1The 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 |
| F4 Patch | Active comparator | Device: The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1The 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic lumbar spine pain due to muscle contractures or over-use
- a signed informed consent
- patients 30 years of age or older.
Key exclusion criteria (4 listed)
- infections
- neoplastic masses
- neuropathies
- metabolic disorders triggering the lumbar pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1The 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. | Device | F3 Patch, F4 Patch, Placebo |
Primary outcome
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.
Time frame: The VAS scale results were compared, between the different patches, at day 0, 5, 8 and 14.
VAS scale (Visual Analogic Scale)
1 secondary outcome
Changes in the Range Of Motion (ROM)
Time frame: The degrees of motion were absessed at day 0, day 8 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 22339105Wong CH, Lin LC, Lee HH, Liu CF. The analgesic effect of thermal therapy after total knee arthroplasty. J Altern Complement Med. 2012 Feb;18(2):175-9. doi: 10.1089/acm.2010.0815.
- Background: PubMed 21827932Lee CH, Roh JW, Lim CY, Hong JH, Lee JK, Min EG. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of a far infrared-emitting sericite belt in patients with primary dysmenorrhea. Complement Ther Med. 2011 Aug;19(4):187-93. doi: 10.1016/j.ctim.2011.06.004. Epub 2011 Jul 16.
- Background: PubMed 27408698Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
- Background: PubMed 23285483Bagnato GL, Miceli G, Atteritano M, Marino N, Bagnato GF. Far infrared emitting plaster in knee osteoarthritis: a single blinded, randomised clinical trial. Reumatismo. 2012 Dec 20;64(6):388-94. doi: 10.4081/reumatismo.2012.388.
- Background: PubMed 24152215Lai CH, Leung TK, Peng CW, Chang KH, Lai MJ, Lai WF, Chen SC. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study. J Altern Complement Med. 2014 Feb;20(2):123-9. doi: 10.1089/acm.2013.0122. Epub 2013 Oct 23.
- Background: PubMed 27104326Ricci M, Micheloni GM, Perusi F, Corbo VR, Vecchini E, Magnan B. Use of a non-medicated plaster in shoulder tendinopathies. Acta Biomed. 2016 Apr 15;87 Suppl 1:90-4.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background: PubMed 31511784Ma K, Zhuang ZG, Wang L, Liu XG, Lu LJ, Yang XQ, Lu Y, Fu ZJ, Song T, Huang D, Liu H, Huang YQ, Peng BG, Liu YQ. The Chinese Association for the Study of Pain (CASP): Consensus on the Assessment and Management of Chronic Nonspecific Low Back Pain. Pain Res Manag. 2019 Aug 15;2019:8957847. doi: 10.1155/2019/8957847. eCollection 2019.
- Background: PubMed 30252425Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- Background: PubMed 29572160Santos LF, Correia IJ, Silva AS, Mano JF. Biomaterials for drug delivery patches. Eur J Pharm Sci. 2018 Jun 15;118:49-66. doi: 10.1016/j.ejps.2018.03.020. Epub 2018 Mar 20.
- Background: PubMed 25560046Pastore MN, Kalia YN, Horstmann M, Roberts MS. Transdermal patches: history, development and pharmacology. Br J Pharmacol. 2015 May;172(9):2179-209. doi: 10.1111/bph.13059. Epub 2015 Mar 18.
- Background: PubMed 26149780Miller K. Transdermal patches: past, present and future. Ther Deliv. 2015;6(6):639-41. doi: 10.4155/tde.15.16. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Ricci, Professor principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 in people with Back Pain, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: The VAS scale results were compared, between the different patches, at day 0, 5, 8 and 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651426, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.