Untreatable chronic pain
Conditions
Interventions
This is a quasi-experimental, single-arm, unblinded clinical trial. Experimental group: 20 consecutively selected participants with diabetes and diabetic neuropathic pain will undergo 12 weeks of trai
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers with confirmed type I or type II diabetes mellitus (at least 5 years for type I DM) according to the diagnostic criteria of the American Diabetes Association (ADA); both sexes; age over 18 years; distal-to-proximal pain pattern in the lower limbs (stocking distribution)
Exclusion criteria
Exclusion criteria: Volunteers with metallic implants near the stimulation site; decompensated neurological and/or neuropsychiatric disorders (except for diabetic neuropathy); family history of epileptic disorders with monogenic inheritance; personal history of epilepsy, even if treated and compensated; use of illicit drugs; implantation of electrical stimulators (e.g., pacemaker); history of stroke; cognitive and/or consciousness disturbances preventing comprehension of the questionnaires; pregnancy or puerperium; prior cranial manipulation with instrumentation along the electrode path; current brain tumor; decompensated inflammatory dermatological diseases in the cranial region that prevent electrode coupling; motor abnormalities that prevent completion of the exercise protocol; sickle cell anemia; significant macrovascular obstruction with altered peripheral pulses, claudication symptoms, or venous disease grades 5 or 6; arteriovenous fistula in the lower limbs; decompensated coagulation disorders; diagnosis of another neuropathy (besides diabetic neuropathy); uncontrolled heart disease; rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in points on the Brazilian version of the McGill Pain Questionnaire (MPQ) is expected to be found immediately post-intervention compared with the pre-intervention moment | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in neuropathic pain measured by the Brazilian version of the Michigan Neuropathy Screening Instrument is expected to be found immediately post-intervention compared with the pre-intervention moment;A reduction in neuropathic pain measured by the Brazilian version of the Neuropathic Pain Symptoms Inventory is expected to be found immediately post-intervention compared with the pre-intervention moment;A reduction in neuropathic pain measured by the Brazilian version of the Pain Quality Assessment Questionnaire is expected to be found immediately post-intervention compared with the pre-intervention moment;A reduction in neuropathic pain, reflected by a decrease in points on the Neuropathic Symptoms Score, is expected to be found immediately post-intervention compared with the pre-intervention moment;An improvement in muscle functionality, reflected by a reduction in the time on the timed-up-and-go test, is expected to be found immediately post-intervention compared with the pre-intervention moment;An increase in the strength of leg extensor and flexor muscle groups, measured through peak isometric dynamometry, is expected to be found immediately post-intervention compared with the pre-intervention moment;An increase in cutaneous innervation, measured by the density of small fibers in skin biopsy, is expected to be found immediately post-intervention compared with the pre-intervention moment;A reduction in neuropathic pain, reflected by a decrease in points on the Neuropathy Impairment Score, is expected to be found immediately post-intervention compared with the pre-intervention moment | — |
Countries
Brazil
Contacts
Public ContactJean De Souza
Universidade Estadual de Campinas
Outcome results
None listed