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Neuropathic pain in individuals with Type II Diabetes mellitus and physiotherapeutic intervention: clinical, randomized and controlled study

Grant number: 17/26282-3
Support type:Regular Research Grants
Duration: October 01, 2018 - September 30, 2020
Field of knowledge:Health Sciences - Nursing - Public Health Nursing
Principal Investigator:Denise Miyuki Kusahara
Grantee:Denise Miyuki Kusahara
Home Institution: Escola Paulista de Enfermagem (EPE). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
Assoc. researchers:Cristina Dallemole Sartor ; Mônica Antar Gamba

Abstract

Diabetic Neuropathy is related to the duration of Diabetes Mellitus (DM) and inadequate glycemic control, usually occurs between 5 to 10 years of disease diagnosis, causing a greater propensity of peripheral nerve dysfunction. One of the most frequent and insidious symptoms affecting most individuals with Type 2 Diabetes Mellitus (DM2) is neuropathic pain, accompanied by clinical and subclinical manifestations, such as tingling, burning, continuous and throbbing sensation; and allodynia. The diagnosis of neuropathic pain in DM is delayed in clinical practice, and due to this, instruments of evaluation for screening of the diagnostic probability were developed, through questionnaires and scales. For treatment, new physiotherapeutic features like 890 nm monochromatic infrared light have been tested for pain control. The objective of this research will be to measure the prevalence of Diabetic Neuropathy and neuropathic pain in individuals with DM2, and to evaluate a physiotherapeutic intervention in people with neuropathic pain through the application of electrothermo-phototherapy resources, in the city of São João da Boa Vista. The research will be developed in two stages. In the first, by means of a cross-sectional study, diabetic neuropathy and neuropathic pain will be screened. In this phase of the study, validated scales will be used. The second stage is characterized by a randomized, double-blind and controlled clinical trial of the effectiveness of 890nm monochromatic infrared light treatment, applied in sessions lasting 30 minutes for 6 consecutive weeks, with a view to reduction of neuropathic pain in people with DM2 and improvement of their quality of life. Individuals with neuropathic pain will be randomly divided into two groups. In the experiment group, conventional physiotherapy associated with the therapeutic intervention with monochromatic infrared light of 890nm will be performed. The control group will be submitted to conventional physiotherapy, and to ensure the blindness of the research will be used equipment that simulates monochromatic infrared light of 890nm, being an inactive light. The influence of intervention on neuropathic pain will be measured using the Leeds Assessment of Neuropathic Symptoms and Signs Scale used to differentiate neuropathic pain from nociceptive pain, the Brief Pain Inventory to assess pain intensity, the Douleur Neuropathique 4 questionnaire for specific screening of neuropathic pain symptoms, the Michigan Screening Instrument to quantify the progression of people with diabetic neuropathy with neuropathic pain, and abbreviated instrument of quality life WHOQOL-bref . The analysis will be by descriptive and inferential statistics. A significance level of less than or equal to 0.05 was established. (AU)