Invel® Medical Glove - Forearm PAR

Monocentric, prospective, controlled, double-blind and randomized study to evaluate the efficacy and safety of the Invel® Activive Glove. 

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

Introduction

Disorder related to repetitive movement (RSI: repetitive strain injury/WMSD: Work-related musculoskeletal disorder) of the hand and wrist is associated with prolonged absenteeism from work, therefore, associated with greater loss of productivity(1). More than 90% of patients with RSI/WMSD had musculoskeletal pain and a strong association was observed with Myofascial Pain Syndrome (MSD)(2).

Myofascial Pain Syndrome is one of the most common causes of musculoskeletal pain and functional disability. It is little recognized by health professionals, as the diagnosis depends exclusively on the clinical history and physical examination findings. MDS is a regional neuromuscular dysfunction, with trigger points in the tense muscle band and when mechanically stimulated, it presents local pain or referred pain in distant areas. Myofascial pain can be dull, burning and stabbing. It can become extremely strong and can be confused with bone pain, which makes diagnosis difficult.(3) Myofascial trigger point (TP) can cause a tingling sensation and numbness. In this situation, the electroneuromyographic examination and neurological examination are normal. Many of myofascial TrPs are referred pain, that is, they are far from the affected site.(3) Treatment is clinical and consists of medication, physical means, kinesiotherapy, ergonomic guidelines, use of orthoses and postural hygiene to improve pain and functional disability. The use of long infrared radiation emitted by Bioceramics® incorporated into the Invel® Activive Glove can be another adjuvant treatment option to relieve pain and assist in rehabilitation.

goal

Primary: – Verify the effectiveness of Invel® Actiive Glove in muscle pain in patients with myofascial pain syndrome of the wrists.

Secondary: – Assess functional capacity of upper limbs in patients with myofascial pain syndrome; – Evaluate the safety of using the product.

Methodology

A monocentric, prospective, controlled, double-blind and randomized study was carried out, approved by the ethics committee, including a sample of 60 volunteers with muscle pain (SDM) caused by repetitive effort in the upper limbs.

Investigational product: Invel® Activive Glove.

Sixty volunteers of both sexes were selected and, after signing the free and informed consent form, randomized into two groups: Group A (group that used the Invel® Activive Glove) and Group B (placebo, which used the same glove). fabric, but without the incorporation of Bioceramica® MIG3®). Volunteers used it for 6 hours a day for 28 days. For both groups, A and B, 4 visits were planned over 2 months.

Assessment method:

(a) Pain using the Visual Analogue Scale – VAS; (b) Functional Assessment by DASH (Disabilities of the arm, shoulder and hand); (c) Assessment of PGs (using the Fischer algiometer). (d) JAMAR (grip dynamometer) (e) Clinical evaluation

Results

Pain Intensity:

Pain reduction was assessed over time using the visual analogue scale – VAS and a drop in the right arm of 12% in V2, 28% in V3, in Group A (group that used Invel®) Activive Glove) and variation of 11% in V2, 14% in V3 in Group B (placebo).

Clinical Pain Assessment:

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

Functionality:

There was a decrease in DASH scores, suggesting improved functionality in both groups (p<0.0001).

Security:

No clinically significant adverse events were observed in the studied population.

Conclusion

The present study clearly demonstrated that Invel® Activive Glove enhanced the analgesic effect. The light compression exerted by the gloves helps with muscle stabilization and reduces vibration resulting from impact with movements. This product can be used as an adjuvant treatment for pain in the forearms and wrists. ANVISA, the National Health Surveillance Agency, recognized the efficacy and safety of this product and granted ANVISA/MS registration No. 80104760006 on April 25, 2011.

Reference

1. 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. 2. Physical Medicine and Rehabilitation clinics of North Ameica. Myofascial pain: update in diagnosis and treatment. Philadelphia: WB Saynderrs Company 2001. 3. Travell & Simons' Myofascial Pain and Dysfunction The Trigger Point Manual vol 1. Upper Half of Body

Acknowledgment

This research was sponsored by INVEL® (GOEN3 Indústria e Comércio de Artigos para a Saúde Ltda), and the company that carried out the clinical monitoring of the study, hired by the sponsor, was ProSearch Pesquisa Clínica. Research developed by IITP® (Invel Institute of Technology and Research).