Invel® Active Shirt Radiant Light Long Sleeve T-Shirt (Basic Modeling)

CONTROLLED, DOUBLE-BLIND AND RANDOMIZED STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF Invel® Active Shirt Radiant Light Long Sleeve T-Shirt (Basic Modeling) WITH INVEL® TECHNOLOGY 

Manoel Jacobsen Teixeira1, Joaci O. Araújo1, Helena Hideko Seguchi Kaziyama1, Daniel C. Andrade1, Carina Mamy Nishimura1, Mônica Lourdes de Andrade Lima1, Cicília Y. Wada2, Roberta Pessoa Simões3, Sabrina Telles Mathias Pupo3, Marcos Leal Brioschi4 1Pain

Group Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo – USP; 2 Statpharm Scientific Advisory;3 Invel; 4InfraRedMed – Infrared Diagnosis

Introduction

Primary: – Evaluate the effectiveness of the t-shirt, Invel® Activive Shirt on low back pain, especially muscle pain. Secondary: – Evaluate the safety in using the product.

Goal

Primary: – Evaluate the effectiveness of the t-shirt, Invel® Activive Shirt on low back pain, especially muscle pain. Secondary: – Evaluate the safety in using the product.

Methodology

A randomized, double-blind, placebo-controlled, single-center national study was carried out, including a sample of 70 volunteers with a history of chronic low back pain with at least 3 months of evolution on the date of inclusion.

Volunteers were randomized into two groups. One of the groups used the Invel® Activive Shirt (group A) and the other used a shirt without Invel® technology (group B). The volunteers were treated for 14 days and evaluated at times 0, 7, and 14 days.

Assessment method:

a) IGM: The global impression of pain improvement was assessed; (b) Product safety was measured by the proportion of patients who did not experience adverse events, serious or not, related to the use of the product. (c) Thermography: Assess superficial blood perfusion.

Investigational product: Invel® Active Shirt Radiant Light Long Sleeve T-Shirt (Basic Modeling).

Results

70 volunteers of both sexes (77.75% women) were included, with an average age of 48.38 years. The volunteers were randomly allocated, but the study was completed with 29 volunteers who used the Invel® Activive Shirt and 25 non-technology Invel® shirts.

Pain improvement:

Regarding the overall impression of improvement, at visit 3, there was a statistically significant difference between the two (A and B) groups (p=0.0362). The results obtained were “much improved” (A:24.14% vs B:4%) and “moderately improved” (A:44.83% vs B:28%).

Thermography:

The white area in the image represents the affected lumbar region and the red area represents the area of ​​increased blood perfusion. The size of the decrease in the white area was compared between visits V1 and V3 in the two treatment groups A and B. We observed that the improvement in the thermographic pattern in Group A was 24% vs 11% in the control group, group B.

Security:

No clinically significant events were observed in the studied population.

Conclusion

The surface heat promoted by the Invel® Active Shirt Radiant Light Long Sleeve T-Shirt (Basic Modeling) is the result of a photochemical effect. It occurs due to the increase in tissue perfusion promoted by heat, helping to remove substances that cause pain and increasing the supply of oxygen to the area. Using the product does not cure the disease, but it is an auxiliary resource in the treatment of low back pain. The heat promoted by long infrared radiation alleviates painful symptoms, preparing the affected region for the application of other traditional therapies. ANVISA, the National Health Surveillance Agency, recognized the efficacy and safety of this product and granted ANVISA/MS registration N°80104760005 on 01/18/2011.

Reference

1. RAMOS, PE; ABE, GC; OLIVEIRA, ASB Efficiency of fabric impregnated with Bioceramics® in spinal pain. São Paulo, 2006 (Federal University of São Paulo). 2. MACHADO, DP; RODRIGUES, A. Verify the efficiency of the fabric impregnated with Bioceramics® Invel® applied to pain along the spine. University of Campinas. Clinical Hospital. Spine Outpatient Clinic. 2005.

Acknowledgment

This research was sponsored and monitored by INVEL® (GOEN3 Indústria e Comércio de Artigos para a Saúde Ltda). Research developed by IITP® (Invel Institute of Technology and Research).