Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury

NCT ID: NCT04385030

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-08
• Study Completion Date: 2020-02-28

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).

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ETCC Active associated with Mirror Therapy (TE)

The study will consist of 12 sessions, being carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).

Group Type: ACTIVE_COMPARATOR

TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY

Intervention Type: DEVICE

The study will consist of 12 sessions, carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).

ETCC simulated associated with Mirror Therapy (TE)

The study will consist of 12 sessions, being carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).

Group Type: SHAM_COMPARATOR

TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY

Intervention Type: DEVICE

The study will consist of 12 sessions, carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).

Interventions

TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY

The study will consist of 12 sessions, carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Suellen Marinho Andrade

Principal Investigator and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suellen Andrade

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

Locations

Suellen Marinho Andrade

João Pessoa, Paraíba, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33362687 (View on PubMed)

Other Identifiers

NeuroPain

Identifier Type: -

Identifier Source: org_study_id