Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury

NCT04385030 | Completed

• 1 other identifier: NeuroPain
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Change in pain intensity

  Visual analog scale (VAS) - One-dimensional instrument for assessing pain intensity. It is a line with the ends numbered 0-10. At one end line is marked "no pain" and on the other "worse pain imaginable".

  Baseline and after 4 weeks

• Changes in pain interference in activities of daily living

  1 - Brief Pain Inventory - reduced form (Brief Pain Inventory - BPI): Multidimensional instrument, which makes use of a scale of 0-10 to graduate the following items: intensity, pain interference on ability for walking, daily activities of the patient, at work, social activities, mood and sleep.

  Baseline and after 4 weeks

• Change in pain characteristics

  2 - McGill Pain Questionnaire - MPQ): The descriptors are divided into four groups: sensory discriminative, motivational affective, cognitive evaluative, and miscellaneous. The numerical index of descriptors is the number of words chosen by the patient to characterize your pain, being at most a word of each subgroup with a maximum value of 20. The pain index is calculated by adding the values of intensity of each descriptor (0-5), having this maximum 78.

  Baseline and after 4 weeks

Secondary Outcomes (4)

• Quality of life (SF-36)

  Baseline and after 4 weeks

• Functionality

  Baseline and after 4 weeks

• Depression

  Baseline and after 4 weeks

• Anxiety

  Baseline and after 4 weeks

Study Arms (2)

ETCC Active associated with Mirror Therapy (TE)

ACTIVE COMPARATOR

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).

Device: TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY

ETCC simulated associated with Mirror Therapy (TE)

SHAM COMPARATOR

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).

Device: TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY

Interventions

TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY 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 Active associated with Mirror Therapy (TE); ETCC simulated associated with Mirror Therapy (TE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Suellen Marinho Andrade

João Pessoa, Paraíba, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33362687 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation; Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Physical Therapy Modalities; Rehabilitation

Study Officials

• Suellen Andrade

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: May 12, 2020
• Study Start: September 8, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

BR (1)