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

Prevalence of neuropathic pain in individuals with type II Diabetes Mellitus and physical therapy intervention in the city of São João da Boa Vista-SP - : Monochromatic infrared light in diabetes mellitus and neuropathic pain

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-4qdjk6

Enrollment

Unknown

Registered

2020-09-23

Start date

2020-08-03

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulo-dependent diabetes mellitus with neurological complications

Interventions

For intervention, 96 people recruited will be randomly allocated to two homogeneous and double-blinded groups: 48 people in the conventional physiotherapeutic intervention group (CG) for neuropathic p

Other

G63.2

Eligibility

Age

30 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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

Measure	Time frame
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. 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.	—

Countries

Brazil

Contacts

Public ContactDaniella Oggiam

Universidade Federal de São Paulo

dsoggiam@gmail.com+55-019-996159731

Outcome results

None listed

Source: REBEC (via WHO ICTRP)