Quantification of neuropathic pain in people with diabetes and physiotherapy treatment in the city of São João da Boa Vista-SP

Phase 1

Recruiting

• Conditions: Insulo-dependent diabetes mellitus with neurological complications; E10.4

• Registration Number: RBR-4qdjk6
• Lead Sponsor: Daniella Silva Oggiam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Residents, domiciled and registered in the municipal public network (UBSs and
PSFs) of São João da Boa Vista / SP; Cognitive conditions to participate in the study (alert individuals,
mental ability to fulfill the study requirements voluntarily); Age over 30 years old, Both sexes; Diagnosis of DM2 for 5 years or more; Diabetic Neuropathy screening performed through the MNSI Instrument; Presence of neuropathic pain diagnosed by LANNS scales and DN4

Exclusion Criteria

Alcoholism; Decompensated hypothyroidism; Signs of spinal compression, stenosis or radiculopathy; Chronic pains of another nature such as: pain vascular and nociceptive pain; Severe peripheral arterial disease; Association of stroke ischemic or hemorrhagic with DM2; uncontrolled arterial hypertension; pregnancy and lactation; disease malignant disease in the lower limbs; active systemic cancer; posterior knee and / or spine surgery; Score greater than 12 on the Hamilton Depression scale (ANNEX IV); Lack of blood glucose monitoring; Lack of dosage of glycated hemoglobin in the last 6 months; - Decline in free and informed consent
enlightened.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>To evaluate the improvement of neuropathic pain in DM after physical therapy intervention with 890nm monochromatic infrared light for 6 weeks of treatment associated with conventional physiotherapy, evaluated by LANNS, DN4 and BPI assessment instruments.<br>For intergroup and group comparison of the instruments at different times of the intervention protocol, the Kruskal Wallis test, Dun test, Anova, Friedman test and Nemenyi test were used.

Secondary Outcome Measures

Name	Time	Method
Assess whether there is improvement in neuropathic pain in DM, whether it remains even after the end of interventions with pain reevaluation after 30 days using the instruments: LANNS, DN4 and BPI.<br>For intergroup and group comparison of the instruments at different times of the intervention protocol, the Kruskal Wallis test, Dun test, Anova, Friedman test and Nemenyi test were used.