Neurostimulation & Mirror Therapy in Traumatic Brachial Plexus Injury

Status Completed

Clinical Trial Summary

Traumatic injuries of the brachial plexus cause sufficient weakness to affect the individual in its various aspects, limiting the execution of Activities of Daily Living, leading to highly disabling, and often definitive, clinical conditions with serious socioeconomic consequences. It causes motor, sensory and autonomic deficits, directly compromising the quality of life and functional performance of these individuals. It is a complex condition, whose recovery is usually slow and costly, in addition to often requiring surgery and rehabilitation. Among the therapeutic possibilities, the non-invasive neuromodulation techniques stand out, especially the Transcranial Direct Current Stimulation (ETCC) and the Mirror Therapy (ET). In this context, the present study aims to analyze the effectiveness of the ETCC technique combined with ET in the treatment of patients with pain due to trauma to the brachial plexus, investigating the degree of improvement in pain intensity, functionality, quality of life and mood of these patients, comparing the onset with immediately after applying the techniques.

Clinical Trial Description

For this, a pilot clinical trial, placebo-controlled, blind and randomized, will be carried out, involving patients with traumatic brachial plexus injury, submitted to sessions of ETCC and mirror therapy. Participants will be randomly allocated to 1 of 2 groups: the first will receive active ETCC associated with TE and the second will receive simulated ETCC in conjunction with TE. The study will consist of 12 sessions, conducted over a period of 1 month, with 3 sessions weekly on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Assessments will be performed before the beginning of the protocol (baseline) and immediately after the end of the 12 sessions. The TCT-Research device, developed by Trans Cranial Technologies Ltda for ETCC and a rectangular platform with the dimensions of 40x70 cm, with a mirror sagittally coupled to the TE will be used. To assess the outcomes, EVA, McGill's Questionnaire, BPI, BDI, IDATE, SF-36 and CIF will be applied. For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, version 20.0, will be used and considered significant, an alpha value of 5% (p <0.05). ;

Study Design

Related Conditions & MeSH terms

Chronic Pain

Clinical Trial Details

NCT number	NCT04385030
Study type	Interventional
Source	Federal University of Paraíba
Contact
Status	Completed
Phase	N/A
Start date	September 8, 2019
Completion date	February 28, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms