Clinical trial NCT04385030: Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
Official title: Transcranial Direct Current Stimulation and Mirror Therapy in Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Age over 18 years;
* Score of 4 to 10 points on the Visual Analogue Scale;
* Persistent pain and refractory to clinical treatment for at least 3 months;
* Appropriate pharmacological treatment for pain for at least 1 month before the start of the study.

Exclusion Criteria:

* Patients with other neurological diseases;
* Past history of substance abuse;
* Contraindications for ETCC.

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline and after 4 weeks
measure: Changes in pain interference in activities of daily living
timeFrame: Baseline and after 4 weeks
measure: Change in pain characteristics
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Quality of life (SF-36)
timeFrame: Baseline and after 4 weeks
measure: Functionality
timeFrame: Baseline and after 4 weeks
measure: Depression
timeFrame: Baseline and after 4 weeks
measure: Anxiety
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Marinho Andrade
state: PB
Study officials:
affiliation: Federal University of Paraiba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira CM, de Carvalho CD, Gomes R, Bonifacio de Assis ED, Andrade SM. Transcranial Direct Current Stimulation and Mirror Therapy for Neuropathic Pain After Brachial Plexus Avulsion: A Randomized, Double-Blind, Controlled Pilot Study. Front Neurol. 2020 Dec 11;11:568261. doi: 10.3389/fneur.2020.568261. eCollection 2020.