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Invel® Actiive Glove

A SINGLE-CENTER, PROSPECTIVE, CONTROLLED, DOUBLE BLIND AND RANDOMIZED STUDY FOR EVALUATION OF THE EFFICACY AND SAFETY OF INVEL® ACTIIVE GLOVE WITH INVEL® TECHNOLOGY.

Helena Hideko Seguchi Kaziyama1, Manoel Jacobsen Teixeira1, Ricardo Bocatto de Oliveira1, Carina Mamy Nishimura1,Vivian Massayo Kaziyama1, Rosa Alves Targino de Araújo1, Karine A. S. Leão Ferreira1, Cicília Yuko Wada2, Roberta Pessoa Simões3

¹ Pain Group of the Hospital das Clínicas, School of Medicine, University of São Paulo – USP; 2 Statpharm Assessoria Científica; 3 INVEL

Introduction

Repetitive movement related disorder (RSI: repetitive strain injury / WRMD: Work related musculoskeletal disorder) of the hand and the wrist is associated with extended absenteeism from work, therefore, associated with the greater productivity loss (1). More than 90% of patients with RSI / WRMD prevented musculoskeletal pain and strong association with Myofascial Pain Syndrome (MPS)(2) was observed.

Myofascial Pain Syndrome is one of the most common causes of musculoskeletal pain and functional incapacity. It is little recognized by health professionals, since the diagnosis depends exclusively on clinical history and physical exrtamination findings. MPS is a regional neuromuscular dysfunction, with trigger points in the tense bands of muscle fibers and when stimulated mechanically it presents local or referred pain in distant areas. Myofascial pain can be silent, in intense heat and stabbing sensation. It can become extremely strong that it can be confounded with a bone pain, which hampers diagnosis.(3) Myofascial trigger point (TP) can cause a tingling sensation and numbness. In this situation, the electroneuromyographic examination and the neurological examination are normal. Many of the myofascial TPs are referred pain, that is, they are far from the stricken site. (4) Treatment is clinical and consists in medication, physical means, kinesiotherapy, ergonomic orientations, use of orthosis, and postural hygiene for improvement of pain and functional incapacity. The use of long-wave infrared radiation emitted by Biocerâmica® incorporated in Invel® Actiive Glove can be another coadjuvant treatment option for alleviating pain and aiding in rehabilitation.(3)

Objective

Primary objective: To verify the efficacy of Invel® Actiive Glove in muscular pain inpatients with myofascial pain syndrome in the wrists.

Secondary objective: To evaluate functional capacity of upper limbs of patients with myofascial pain syndrome; – To evaluate safety in the use of the product.

Methodology

A single-center, prospective, controlled, double blind and randomized study was performed, approved by the independent ethics committee on research, including a sample of 60 subjects suffering from muscular pain (MPS) caused by repetitive strain on the upper limbs.

Investigational product: Invel® Actiive Glove.

Methodology
Sixty (60) subjects from both genders were selected and, after signing the informed consent form, randomized into two groups: Group A (group that used Invel® Actiive Glove) and Group B (placebo, which used the glove of the same fabric, however with the incorporation of Biocerâmica® MIG3®). The subjects used for 6 hours daily for 28 days. For the two groups, A and B, four (4) visits were planned in the course of 2 months.

invel glove table

Means of evaluation:

(a) Pain by the Visual Analog Scale – VAS; (b) DASH (Disabilities of the arm, shoulder and hand) Functional Assessment; (c) Assessment of the TPs (by the Fischer algometer) (d) JAMAR (grip dynamometer) (e) Clinical assessment

Results

Intensity of Pain:

Pain reduction was evaluated in the course of time through the Visual Analog Scale – VAS and a drop was confirmed in the right arm by 12% in V2, 28% in V3, in Group A (group that used Invel® Actiive Glove) and variation of 11% in V2, 14% in V3 in Group B (placebo).

Clinical Assessment of the Pain:

The location and reduction of pain were assessed and we observed significant differences in their absence at times of 14, 28 and 56 days compared to the baseline time, at the elbow and wrist, with 5% significance level.

Functionality:

There was decrease of DASH scores, suggesting improvement of functionality in the two groups (p< 0.0001).<

Safety:

No clinically significant adverse event was verified in the studied population.

study-glove

Conclusion

This study showed clearly that Invel® Actiive Glove leveraged the analgesic effect. Mild compression exercised by the gloves aids in muscular stabilization and reduces vibration resulting from impact with movements. This product can be used as coadjuvant treatment in pain of the forearms and wrists. ANVISA, National Health Surveillance Agency, recognized the efficacy and safety of this product and granted the registration ANVISAMS Nº 80104760006 on April 25, 2011.

Reference

Kaergaard A, Andersen JH. Musculoskeletal disorders of the neck and shoulders in female sewing machine operators: prevalence, incidence, and prognosis Occup Environ Med; 2000, 57:528-534. Physical Medicine and Rehabilitation clinics od North America. Myofascial pain: update in diagnosis and treatment. Philadelphia: WB Saynderrs Company 2001. Travell & Simons’ Myofascial Pain and Dysfunction The Trigger Point Manual vol 1. Upper Half of Body

Acknowledgment

This research was financed by Invel® (GOEN3 Indústria e Comércio de Artigos para a Saúde Ltda), and the company that conducted the clinical monitoring of the study, hired by the sponsor, was ProSearch Pesquisa Clínica. Research developed by IITP® (Instituto Invel de Tecnologia e Pesquisa).

Learn more about Invel® Gloves and how to buy

http://loja.invel.com.br/dor-nas-maos-punhos-e-bracos-901/c

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