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Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Suellen Marinho Andrade

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ETCC Active associated with Mirror Therapy (TE)

ETCC simulated associated with Mirror Therapy (TE)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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".
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.
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.

Secondary Outcome Measures

Quality of life (SF-36)
The Medical Outcomes Short-Form Health Survey (SF-36) - a general health assessment instrument, originally created in English, which is easy to administer and understand. It consists of 36 questions, covering eight components, functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health assessed by 35 questions and one more comparative question between current and health one year ago.
Functionality
International Classification of Functionality, Disability and Health (ICF) - formed by categories and their subdivisions, or constructs, of different dimensions, including parts of the body. It covers functionality as activity and participation, that is, what human beings can do in different situations or under the influence of different environments, for example. Each category or construct is related to a set that must be completed by qualifiers, numbers that indicate the magnitude of a problem within a specific category. In general, the user must select the categories and qualifiers that identify and express each case.11 The classification must be made based on the multidirectional model of functionality, which integrates the different dimensions, establishing relationships between the environment, the performance of activities and social participation.
Depression
The Beck Depression Inventory (BDI) - originally developed by Beck, Ward, Mendelson, Mock and Erbaugh (1961). It is a self-report scale to survey the intensity of depressive symptoms (Beck & Steer, 1993; Rosa, Malandrin, Leite & Silva, 1986), consisting of 21 items and reliability estimates established from six samples psychiatric disorders (Beck & Steer, 1993) that varied between 0.79 and 0.90.
Anxiety
State-Trait Anxiety Inventory (STAI) - It was prepared by Spielberger, Gorsuch and Lushene (1970) and translated and adapted to Brazil by Biaggio (Biaggio & Natalício 1979). Consisting of 2 self-report scales that assess anxiety as a state (STAI-E) or trait (STAI-T). Each situation (state and trait) has 20 items with scores from 1 to 4 in each one. The score ranges from 20 to 80. For each question the score corresponding to the answer is assigned, but for questions with a positive character the score is reversed.

Full Information

First Posted
February 23, 2020
Last Updated
May 11, 2020
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT04385030
Brief Title
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
Official Title
Transcranial Direct Current Stimulation and Mirror Therapy in Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETCC Active associated with Mirror Therapy (TE)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ETCC simulated associated with Mirror Therapy (TE)
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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".
Time Frame
Baseline and after 4 weeks
Title
Changes in pain interference in activities of daily living
Description
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.
Time Frame
Baseline and after 4 weeks
Title
Change in pain characteristics
Description
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.
Time Frame
Baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
Quality of life (SF-36)
Description
The Medical Outcomes Short-Form Health Survey (SF-36) - a general health assessment instrument, originally created in English, which is easy to administer and understand. It consists of 36 questions, covering eight components, functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health assessed by 35 questions and one more comparative question between current and health one year ago.
Time Frame
Baseline and after 4 weeks
Title
Functionality
Description
International Classification of Functionality, Disability and Health (ICF) - formed by categories and their subdivisions, or constructs, of different dimensions, including parts of the body. It covers functionality as activity and participation, that is, what human beings can do in different situations or under the influence of different environments, for example. Each category or construct is related to a set that must be completed by qualifiers, numbers that indicate the magnitude of a problem within a specific category. In general, the user must select the categories and qualifiers that identify and express each case.11 The classification must be made based on the multidirectional model of functionality, which integrates the different dimensions, establishing relationships between the environment, the performance of activities and social participation.
Time Frame
Baseline and after 4 weeks
Title
Depression
Description
The Beck Depression Inventory (BDI) - originally developed by Beck, Ward, Mendelson, Mock and Erbaugh (1961). It is a self-report scale to survey the intensity of depressive symptoms (Beck & Steer, 1993; Rosa, Malandrin, Leite & Silva, 1986), consisting of 21 items and reliability estimates established from six samples psychiatric disorders (Beck & Steer, 1993) that varied between 0.79 and 0.90.
Time Frame
Baseline and after 4 weeks
Title
Anxiety
Description
State-Trait Anxiety Inventory (STAI) - It was prepared by Spielberger, Gorsuch and Lushene (1970) and translated and adapted to Brazil by Biaggio (Biaggio & Natalício 1979). Consisting of 2 self-report scales that assess anxiety as a state (STAI-E) or trait (STAI-T). Each situation (state and trait) has 20 items with scores from 1 to 4 in each one. The score ranges from 20 to 80. For each question the score corresponding to the answer is assigned, but for questions with a positive character the score is reversed.
Time Frame
Baseline and after 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suellen Marinho Andrade
City
João Pessoa
State/Province
PB
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33362687
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.
Results Reference
derived

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Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury

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