Neoplasms Peripheral Nervous System Diseases
Conditions
Interventions
This is a randomized controlled clinical trial with two periods using a crossover design and single masking
Sixty participants will be randomly allocated through a computer generated sequence into two intervention sequences
Group 1 with 30 participants will receive active photobiomodulation in the first period and placebo in the second period
Group 2 with 30 participants will receive placebo in the first period and active photobiomodulation in the second period
Each period will last two weeks with two sessions per week totaling four sessions per phase and a fourteen day interval between periods
Participants will be blinded to allocation and the researcher responsible for delivering the intervention and performing the assessments will not be blinded
Active photobiomodulation will be delivered using a class three B device model Antares manufactured by Ibramed with a cluster contact area of approximately eighty square centimeters containing thirtee
Application will be performed bilaterally along the cervicobrachial nerve pathway including the brachial plexus region in the cervical area the entire anteri
Sponsors
Centro Universitário das Faculdades Associadas de Ensino - FAE
Ibramed - Industria Brasileira de Equipamentos Médicos
Eligibility
Inclusion criteria
Inclusion criteria: Those who have previously used vitamin B; analgesics such as paracetamol or NSAIDs (non-steroidal antiinflammatory drugs); and nonpharmacological approaches such as conventional physiotherapy; massages or unsupervised home exercises will be included
Exclusion criteria
Exclusion criteria: Patients with a history of peripheral neurological disease prior to chemotherapy; decompensated diabetes mellitus (blood glucose180 mgdL (milligrams per deciliter)); chronic alcoholism or current use of specific pharmacological agents for the treatment of CIPN (chemotherapy induced peripheral neuropathy) will be excluded; Patients who begin any type of structured physical intervention during the study will also be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the intensity of neuropathic symptoms in the upper limbs is expected, measured by the Douleur Neuropathique Four Questionnaire short version, comparing the variation between the beginning and the end of each intervention period, with analysis of the mean difference between the active photobiomodulation condition and the placebo condition, with data collected before the start and at the end of each two week phase | — |
Secondary
| Measure | Time frame |
|---|---|
| An increase in segmental isometric muscle strength of the upper limbs is expected, assessed by manual dynamometry in the shoulder, elbow and hand grip muscle groups, with analysis of the variation between the beginning and the end of each period and comparison of the mean difference between the active photobiomodulation condition and the placebo condition, with assessments performed before and after each two week phase | — |
Countries
BR
Contacts
Public ContactLaura Rezende
Centro Universitário das Faculdades Associadas de Ensino - FAE
Outcome results
None listed