Use of a non-medicated plaster in chronic lumbar back pain: a randomized controlled trial

Use of a non-medicated plaster in chronic lumbar back pain: a randomized controlled trial


  • Matteo Ricci AOUI Verona
  • Alessio Mulone AOUI Verona
  • Nicholas Elena a:1:{s:5:"en_US";s:11:"AOUI Verona";}
  • Eugenio Vecchini AOUI Verona
  • Roberto Valentini AOUI Verona
  • Margherita Gelmini AOUI Verona


lumbar pain, non-medicated patches, FIR, conservative treatment



The latest technology on far infrared radiations reflects the radiations emitted by the human body and induces an antalgic and anti-inflammatory effect without active ingredients. Our primary aim was to assess pain level modifications throughout the treatment period with two different types of patches, compared to a placebo. As secondary aims, we focused on addressing patients’ quality of life and range of motion changes with each patch.

METHODS: We assessed 54 patients with chronic lumbar back pain treated with FIT Therapy (far infrared technology) patch. Three different types of FIT Therapy patches (F4, F3, and placebo) were used according to the different power of action and patients allocated in a randomized fashion into the 3 arms of the study. Every single patient was assessed during the study using the VAS pain scale, the Roland Morris Disability Questionnaire for quality of life, and ROM for a total of 14 days.

RESULTS: Only the F4 patch group significantly reduced pain level at T14 compared to the placebo group (p<0.05). Meanwhile, F3 showed only a non-significant decrease compared to placebo (p=0.254). In terms of lifestyle improvements, both F3 and F4 recorded a decrease on the RMDQ of 4 and 6 points, respectively.

CONCLUSIONS: Currently, we still need further studies with longer follow-up to consider the FIT Therapy patches F4 a valid alternative as a “non-medicated pain relief”, but it proved to have a role in alleviating painful symptoms and improving function in chronic lumbar back pain without adverse events.


Miller JAA, Schmatz C, Schultz AB. Lumbar disc degeneration: Correlation with age, sex, and spine level in 600 autopsy specimens. Spine. 1988; 13:173–178 PMID: 3406837

Boos N, Weissbach S, Rohrbach H, Weiler C, Spratt KF, Nerlich AG. Classification of age-related changes in lumbar intervertebral discs: 2002 Volvo Award in basic science. Spine. 2002; 27:2631–44

Fujiwara A, Lim TH, An HS, Tanaka N, Jeon CH, Andersson GB, Haughton VM. The effect of disc degeneration and facet joint osteoarthritis on the segmental flexibility of the lumbar spine. Spine. 2000; 25:3036–44.

Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508

Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians, Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. PMID: 28192789.

Li K, Zhang Z, Liu NF, Feng SQ, Tong Y, Zhang JF, Constantinides J, Lazzeri D, Grassetti L, Nicoli F, Zhang YX. Efficacy and safety of far infrared radiation in lymphedema treatment: clinical evaluation and laboratory analysis. Lasers Med Sci. 2017 Apr;32(3):485-494 DOI: 10.1007/s10103-016-2135-0

Wang YH, Cheng FY, Chao YC, Liu CY, Chang Y. Effects of Far-Infrared Therapy on Foot Circulation Among Hemodialysis Patients With Diabetes Mellitus. Biol Res Nurs. 2020 Jul;22(3):403-411 DOI: 10.1177/1099800420923730

Lee, C. H. et al. 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; 19, 187–193. DOI: 10.1016/j.ctim.2011.06.004

Wong, C. H., Lin, L. C., Lee, H. H. & Liu, C.-F. The analgesic effect of thermal therapy after total knee arthroplasty. J Altern Complement Med 2012; 18, 175–179 (2012). DOI: 10.1089/acm.2010.0815

Allegri 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;5. DOI: 10.12688/f1000research.8105.2

Bagnato, G. L., Miceli, G., Atteritano, M., Marino, N. & Bagnato, G. F. Far infrared emitting plaster in knee osteoarthritis: a single blinded, randomised clinical trial. Reumatismo 2012; 64, 388– 394. DOI: 10.4081/reumatismo.2012.388

Lai, C.-H. et al. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study. J Altern Complement Med 2014; 20, 123–129. DOI: 10.1089/acm.2013.0122

Nunes RFH, Cidral-Filho FJ, Flores LJF, Nakamura FY, Rodriguez HFM, Bobinski F, De Sousa A, Petronilho F, Danielski LG, Martins MM, Martins DF, Guglielmo LGA. Effects of Far-Infrared Emitting Ceramic Materials on Recovery During 2-Week Preseason of Elite Futsal Players. J Strength Cond Res. 2020 Jan;34(1):235-248. doi: 10.1519/JSC.0000000000002733

Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14. PMID: 28192793.

Lai YT, Chan HL, Lin SH, Lin CC, Li SY, Liu CK, Teng HW, Liu WS. Far-infrared ray patches relieve pain and improve skin sensitivity in myofascial pain syndrome: A double-blind randomized controlled study. Complement Ther Med. 2017 Dec;35:127-132. doi: 10.1016/j.ctim.2017.10.007. Epub 2017 Nov 4. PMID: 29154057.

Chang Y. The effect of far infrared radiation therapy on inflammation regulation in lipopolysaccharide-induced peritonitis in mice. SAGE Open Med. 2018 Sep 10;6:2050312118798941. DOI: 10.1177/2050312118798941.

Palmieri, B., Vadalà, M., & Laurino, C. The FIT therapy for the treatment of musculoskeletal and neurological disorders related symptoms: A retrospective observational study. Asian Journal of Medical Sciences. 2019; 10(5), 6-12. DOI: 10.3126/ajms.v10i5.21230

Santos 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

Predel HG, Connolly MP, Bhatt A, Giannetti B. Efficacy and safety assessment of acute sports-related traumatic soft tissue injuries using a new ibuprofen medicated plaster: results from a randomized controlled clinical trial. Phys Sportsmed. 2017 Nov;45(4):418-425. DOI: 10.1080/00913847.2017.1382305

Pastore 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. DOI: 10.1111/bph.13059

Miller K. Transdermal patches: past, present and future. Ther Deliv. 2015;6(6):639-41. DOI: 10.4155/tde.15.16

Nunes RFH, Dittrich N, Duffield R, Serpa MC, Coelho TM, Martins DF, Guglielmo LGA.Effects of Far-Infrared Emitting Ceramic Material Clothing on Recovery after Maximal Eccentric Exercise. J Hum Kinet. 2019 Nov;70:135-144. DOI: 10.2478/hukin-2019-0028

Tsai 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

Vatansever 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. PMID: 23833705; PMCID: PMC3699878.

Johnstone DM, et al. Turning-On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Frontiers in Neuroscience. 2016; 9(500) DOI: 10.3389/fnins.2015.00500

Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012; 4:255–266. DOI: 10.1515/plm-2012-0034

Oosterveld FG, et al. Infrared sauna in patients with rheumatoid arthritis and ankylosing spondylitis. A pilot study showing good tolerance, short-term improvement of pain and stiffness, and a trend towards long-term beneficial effects. Clin Rheumatol. 2009; 28(1):29–34 DOI: 10.1007/s10067-008-0977-y

Loturco I, Abad C, Nakamura FY, Ramos SP, Kobal R, Gil S, Pereira LA, Burini F, Roschel H, Ugrinowitsch C, Tricoli V. Effects of far infrared rays emitting clothing on recovery after an intense plyometric exercise bout applied to elite soccer players: a randomized double-blind placebo-controlled trial. Biol Sport. 2016 Sep;33(3):277-83. DOI: 10.5604/20831862.1208479

Hausswirth C, Louis J, Bieuzen F, Pournot H, Fournier J, Filliard JR, Brisswalter J.Effects of whole-body cryotherapy vs. far-infrared vs. passive modalities on recovery from exercise-induced muscle damage in highly-trained runners. PLoS One. 2011;6(12):e27749. DOI: 10.1371/journal.pone.0027749

Romanenko S, Begley R, Harvey AR, Hool L and Wallace VP. The interaction between electromagnetic fields at megahertz, gigahertz and terahertz frequencies with cells, tissues and organisms: risks and potential. J R Soc Interface. 2017 Dec;14(137). DOI: 10.1098/rsif.2017.0585

Ervolino F, Gazze R. Far infrared wavelength treatment for low back pain: Evaluation of a non-invasive device. Work. 2015;53(1):157-62. doi: 10.3233/WOR-152152

Hashish I, Hai HK, Harvey W, et al. Reduction of postoperative pain and swelling by ultrasound treatment: A placebo effect. Pain 1988;33:303–311. DOI: 10.1016/0304-3959(88)90289-8

Vase L, Robinson ME, Verne GN, Price DD. The contributions of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients: An empirical investigation. Pain 2003;105:17–25. DOI: 10.1016/s0304-3959(03)00073-3.

Ervolino F, Gazze R. Far infrared wavelength treatment for low back pain: Evaluation of a non-invasive device. Work. 2015;53(1):157-62. DOI: 10.3233/WOR-152152.

Gale GD, Rothbart PJ, Li Y. Infrared therapy for chronic low back pain: a randomized, controlled trial. Pain Res Manag. 2006 Autumn;11(3):193-6. DOI: 10.1155/2006/876920.







How to Cite

Use of a non-medicated plaster in chronic lumbar back pain: a randomized controlled trial. Acta Biomed [Internet]. 2022 Aug. 31 [cited 2024 Jun. 13];93(4):e2022260. Available from:

Most read articles by the same author(s)

1 2 3 > >>