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Pain Evaluation and Treatment in Clinical Settings

Primary Purpose

Chronic Pain, Functional Limitations, Musculoskeletal Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
tDCS associated to functional activities
Conservative physiotherapy
Sponsored by
Rubens da Silva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Pain, EEG, TMS

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults males and females
  • Age ≥ 20 years and older (≤ 85)
  • Body mass index (BMI) between 18 and 35 kg/m2
  • From local the community, or be in the waiting list, or be admitted in ISCAL - Irmandande Santa Casa de Londrina (Londrina Santa Casa Hospital)
  • Present, at least, 1 diagnosis of musculoskeletal disorder (medical diagnosis declared by the doctors of the clinical team of the hospital)
  • Be able to present to the room and perform the tests and functional tasks, without and with minimal assistance
  • Present a cognitive state greater than 20 in Mini-Mental State Examination.

Exclusion Criteria:

  • Cancer
  • Red flags (infection, tumor, etc.)
  • Severe psychiatric disorders
  • Palliative care
  • Congenital spinal deformity (spondylolysis, intervertebral fusions, 4 lumbar vertebrae)
  • Fairly severe systemic syndromes or diseases that may preclude testing
  • Stroke - very acute phase (1 week) and this is until medial hemodynamic stability
  • Any drugs or condition that could affect EEG or rMT measurements

Sites / Locations

  • Karen Fernandes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1 : conservator physiotherapy

Group 2- tDCS associated to functional activities

Arm Description

Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.

The intervention will start by a pretest on the first day (day 0, baseline record). Tdcs will be applied associated to physical task from functional activity of daily life. Functional task for the assessment of pain with high-tech tools for the implementation an experimental workstation, consisting in a hairdressing dummy head fixed to a telescopic table, adjustable to each individual's height. The dummy will be set at the height of the hands in a constrained position for the arms, i.e. with elbows flexed at 60 degrees. Elbow angles will be adjusted in a static position with a manual goniometer. The task will be performed in a standing position inside a 1m2 perimeter during 30 minutes. The elbow will be in a prolonged constraint position, undergoing repetitive movements, for 30 consecutive minutes. Performing a repetitive manual gesture. The cycle will be executed at a cadence of 30s/cycle with a metronome beat

Outcomes

Primary Outcome Measures

Subjective and perception pain (score 1 to 10 numerical)
The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS)
Subjective and perception pain (score total)
Pain measurement using the Brain pain inventory (BPI) questionnaire. The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely
Objective pain by algometer (units in kgf)
Algometer measurement for assessing the pressure pain threshold using a digital device in kgf.
Functional test #1 - The sitting-rising test (SRT; unit number of support from 10 to 1).
he SRT basically consists in the quantification of the number of support (hands and/or knees, or hands or forearms on knees) one utilizes in order to sit and to rise from the floor. Independent grades are provided to each of the two actions - sitting and rising. The maximal grade is 5 for each one of the actions, losing one point for each support and additional half point for any detectable unbalance. The SRT allows, in very short time and practically in any place, the evaluation of many items - flexibility of lower limb joints, balance, motor coordination, and muscle power/body weight relationship - at the same time, which could be perhaps characterized as minimum functional muscular fitness.
Functional test #2 - Five Times Sit-to-Stand Test (Unit time in seconds)
Assesses functional lower extremity strength, transitional movements, balance, and fall risk.Therapist Instructions: Have the patient sit with their back against the back of the chair. Count each stand aloud so that the patient remains oriented. Stop the test when the patient achieves the standing position on the 5th repetition. Patient Instructions: "Please stand up straight as quickly as you can 5 times, without stopping in between. Keep your arms folded across your chest. I'll be timing you with a stopwatch. Ready, begin
Functional test #3 Timed Up and Go test (TUG, unit time in seconds)
Purpose: To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
Nordic Musculoskeletal Questionnaire (NMQ)
The Nordic Musculoskeletal Questionnaire (NMQ) quantifies musculoskeletal pain and activity prevention in 9 body regions. The questionnaire can determine the prevalence of chronic pain across all participants. The NMQ is a self-administrated standardized questionnaire collecting sociodemographic information, health status, and musculosketal region pain.

Secondary Outcome Measures

Muscle measurement by recording EMG signals (Units in microvolts μV)
Muscular activity will be measured durinh physical function .e. under 30-minutes of an experimental functional task, time up and go test and a 6 meters walk test, using a wireless BTS FREEEMG 300
Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz)
Brain measurement by recording EEG signals at rest, during physical function i.e. under 30-minutes of an experimental functional task, time up and go test and a 6 meters walk test, using an Emotiv wireless EPOC® EEG Headset
Cortical excitability was assessed with the resting motor threshold (rMT) using a Transcranial Magnetic Stimulator (Units in microvolts μV)
Transcranial Magnetic Stimulator (Magstim Company Ltd., UK). rMT was defined as the minimal intensity of stimulation capable of eliciting MEPs of at least 50 yV in 50% of the trials with the muscle at rest, expressed in percentage of the maximum stimulator output. rMT will be assessed at day 0 after 6 weeks.

Full Information

First Posted
November 19, 2021
Last Updated
May 8, 2023
Sponsor
Rubens da Silva
Collaborators
Londrina Santa casa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05197777
Brief Title
Pain Evaluation and Treatment in Clinical Settings
Official Title
Innovations in Pain Assessment and Treatment for Individuals With Musculoskeletal Disorders: Brazil and Canada Collaboration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rubens da Silva
Collaborators
Londrina Santa casa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This new research projet in pain is enrolled into an international official collaboration between researchers and clinicians from Irmandade da Santa Casa de Londrina (ISCAL) and those from two Quebec universities: University of Quebec in Chicoutimi (UQAC) and University of Quebec in Rimouski (UQAR). ISCAL as a living laboratory research environment (sites, equipment, technology) for researchers, clinicians, students, and patients pool will make this project unique in the world, especially to stablish an integral concept on pain from identification, assessment and management, using neurophysiological central measures across patients with neuromusculoskeletal disorders. ISCAL in partnership with Santa Hospital in Londrina admit so many patients per day suffering of pain, by supporting a specific size of sample for establishment of this integral concept in pain. This project builds on the foundations already well installed at ISCAL for data acquisition and storage, from an ideal set-up including patients with pain and clinicians. ISCAL infrastructure will be used to improve the acquirement of pain data from patients, using high-tech tools in a simple and robust experimental protocol targeting the central nervous system (CNS). Pain conventional evaluation (by questionnaires or simple questions related to pain intensity from anamneses or inspection doctor) will be completed by neurophysiological measures of the CNS activity based on the acquisition of biological signals and related to functional activities of the patients. A specific physiological behavior of pain will be determinate, using different types of preprocessing and statistical analyzes on biological signals. While pain and physical dysfunction mechanisms involve through the CNS, measurements from the CNS will allow to better understand the profiles and needs of the population (active adults and older people) suffering from pain and disabilities. The knowledge acquired throughout this research program will improve the pain care in Santa Casa Hospital, the evidence-based practices (EBP) on site by specialist doctors and health professionals (nursing, medical, physiatry, physiotherapist etc.), and mainly will improve the quality of life of patients with pain. This project is a sharing of expertise beneficial to both poles, including the training of students, the use of advanced technologies and the exploration of new avenues in pain research grounded on the development of ISCAL in an international collaboration perspective. All of the work from this research program aims to make ISCAL the reference center for chronic pain in Paraná (south of country) and further, for all Brazil.
Detailed Description
The purpose of this project is to detect pain and introduce an evaluation protocol and innovative therapeutic approach in the treatment of patients with chronic pain. This project activities will be developed within the ISCAL structure, in five phases, as follows: Phase 1 - In this phase, it is aimed to determine the profile of patients admitted to the ISCAL outpatient clinic (pain profile, location of pain, age, gender, type of disorder, duration of symptoms, main functional limitations, type of work, among other variables), as well as, from meetings between the researchers, to establish a standardized pain assessment protocol using simple and high-tech measurement in different patients with musculoskeletal disorders; Phase 2 - This phase aims to determine the psychometric properties of biological measures of the central nervous system (such as parameters from electroencephalography and transcranial magnetic stimulation) in the context of neuromusculoskeletal pain. A secondary objective would also be to assess the validity (concurrent validity by correlations between measures), reliability (test-retest measure), and specificity of these measures; Phase 3 - In this phase, we aim to determine the sensitivity of pain detection measures from electroencephalography data and muscle fatigue (analyzed by electroneuromyography signals) in individuals with musculoskeletal disorders compared to age- and sex-matched controls. Phase 4 - In this phase, the objective is to verify the effect of pain management intervention using a combination of direct current stimulation neuromodulation (tDCS), transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (rTMS) protocols and other alternative pain management in individuals with musculoskeletal disorders. Finally in Phase 5, the objective is to provide subsidies for the creation of a research laboratory in pain, as well as possible workshops and lectures for the transfer of knowledge. From this project, it is expected to contribute to a better knowledge of the mechanisms and neuromodulation of pain in the context of musculoskeletal disorders as well as to develop an evaluation protocol for these patients and help in future interventions or therapeutic options. Moreover, the use of validated assessment and treatment tools could represent an innovation in the rehabilitation context at ISCAL, and could bring benefits to the functionality and quality of life of patients with musculoskeletal disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Functional Limitations, Musculoskeletal Disorders
Keywords
Pain, EEG, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : conservator physiotherapy
Arm Type
Active Comparator
Arm Description
Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.
Arm Title
Group 2- tDCS associated to functional activities
Arm Type
Experimental
Arm Description
The intervention will start by a pretest on the first day (day 0, baseline record). Tdcs will be applied associated to physical task from functional activity of daily life. Functional task for the assessment of pain with high-tech tools for the implementation an experimental workstation, consisting in a hairdressing dummy head fixed to a telescopic table, adjustable to each individual's height. The dummy will be set at the height of the hands in a constrained position for the arms, i.e. with elbows flexed at 60 degrees. Elbow angles will be adjusted in a static position with a manual goniometer. The task will be performed in a standing position inside a 1m2 perimeter during 30 minutes. The elbow will be in a prolonged constraint position, undergoing repetitive movements, for 30 consecutive minutes. Performing a repetitive manual gesture. The cycle will be executed at a cadence of 30s/cycle with a metronome beat
Intervention Type
Device
Intervention Name(s)
tDCS associated to functional activities
Intervention Description
The intervention will start by a pretest on the first day (day 0, baseline record). Tdcs will be applied associated functional task from an experimental workstation, consisting in a hairdressing dummy head fixed to a telescopic table, adjustable to each individual's height. Elbow angles will be adjusted in a static position with a manual goniometer (60 degrees). The task will be performed in a standing position inside a 1m2 perimeter during 30 minutes, undergoing repetitive movements. Performing a repetitive manual gesture. The cycle will be executed at a cadence of 30s/cycle with a metronome beat. The TCT - tDCS Stimulator Kit Research version, with 35 cm2 on M1 of the contralateral hemisphere for the rigth dominant hand. During the first 30 s of active tDCS, an initial period of ''ramping up'' is administered, in which the stimulator reaches the maximum programmed current (2 mA) to mimic cutaneous perceptions. A 2 mA intensity will be maintained during activity.
Intervention Type
Other
Intervention Name(s)
Conservative physiotherapy
Intervention Description
Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.
Primary Outcome Measure Information:
Title
Subjective and perception pain (score 1 to 10 numerical)
Description
The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS)
Time Frame
Change from baseline at 6 weeks
Title
Subjective and perception pain (score total)
Description
Pain measurement using the Brain pain inventory (BPI) questionnaire. The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely
Time Frame
Change from baseline at 6 weeks
Title
Objective pain by algometer (units in kgf)
Description
Algometer measurement for assessing the pressure pain threshold using a digital device in kgf.
Time Frame
Change from baseline at 6 weeks
Title
Functional test #1 - The sitting-rising test (SRT; unit number of support from 10 to 1).
Description
he SRT basically consists in the quantification of the number of support (hands and/or knees, or hands or forearms on knees) one utilizes in order to sit and to rise from the floor. Independent grades are provided to each of the two actions - sitting and rising. The maximal grade is 5 for each one of the actions, losing one point for each support and additional half point for any detectable unbalance. The SRT allows, in very short time and practically in any place, the evaluation of many items - flexibility of lower limb joints, balance, motor coordination, and muscle power/body weight relationship - at the same time, which could be perhaps characterized as minimum functional muscular fitness.
Time Frame
Change from baseline at 6 weeks
Title
Functional test #2 - Five Times Sit-to-Stand Test (Unit time in seconds)
Description
Assesses functional lower extremity strength, transitional movements, balance, and fall risk.Therapist Instructions: Have the patient sit with their back against the back of the chair. Count each stand aloud so that the patient remains oriented. Stop the test when the patient achieves the standing position on the 5th repetition. Patient Instructions: "Please stand up straight as quickly as you can 5 times, without stopping in between. Keep your arms folded across your chest. I'll be timing you with a stopwatch. Ready, begin
Time Frame
Change from baseline at 6 weeks
Title
Functional test #3 Timed Up and Go test (TUG, unit time in seconds)
Description
Purpose: To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
Time Frame
Change from baseline at 6 weeks
Title
Nordic Musculoskeletal Questionnaire (NMQ)
Description
The Nordic Musculoskeletal Questionnaire (NMQ) quantifies musculoskeletal pain and activity prevention in 9 body regions. The questionnaire can determine the prevalence of chronic pain across all participants. The NMQ is a self-administrated standardized questionnaire collecting sociodemographic information, health status, and musculosketal region pain.
Time Frame
Change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Muscle measurement by recording EMG signals (Units in microvolts μV)
Description
Muscular activity will be measured durinh physical function .e. under 30-minutes of an experimental functional task, time up and go test and a 6 meters walk test, using a wireless BTS FREEEMG 300
Time Frame
Change from baseline at 6 weeks
Title
Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz)
Description
Brain measurement by recording EEG signals at rest, during physical function i.e. under 30-minutes of an experimental functional task, time up and go test and a 6 meters walk test, using an Emotiv wireless EPOC® EEG Headset
Time Frame
Change from baseline at 6 weeks
Title
Cortical excitability was assessed with the resting motor threshold (rMT) using a Transcranial Magnetic Stimulator (Units in microvolts μV)
Description
Transcranial Magnetic Stimulator (Magstim Company Ltd., UK). rMT was defined as the minimal intensity of stimulation capable of eliciting MEPs of at least 50 yV in 50% of the trials with the muscle at rest, expressed in percentage of the maximum stimulator output. rMT will be assessed at day 0 after 6 weeks.
Time Frame
Change from baseline at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults males and females Age ≥ 20 years and older (≤ 85) Body mass index (BMI) between 18 and 35 kg/m2 From local the community, or be in the waiting list, or be admitted in ISCAL - Irmandande Santa Casa de Londrina (Londrina Santa Casa Hospital) Present, at least, 1 diagnosis of musculoskeletal disorder (medical diagnosis declared by the doctors of the clinical team of the hospital) Be able to present to the room and perform the tests and functional tasks, without and with minimal assistance Present a cognitive state greater than 20 in Mini-Mental State Examination. Exclusion Criteria: Cancer Red flags (infection, tumor, etc.) Severe psychiatric disorders Palliative care Congenital spinal deformity (spondylolysis, intervertebral fusions, 4 lumbar vertebrae) Fairly severe systemic syndromes or diseases that may preclude testing Stroke - very acute phase (1 week) and this is until medial hemodynamic stability Any drugs or condition that could affect EEG or rMT measurements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens Silva, PhD
Phone
4185455011
Ext
6123
Email
rubens.dasilva@uqac.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Fernandes, PhD
Phone
554399219493
Email
karenparron@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzy Ngomo, PhD
Organizational Affiliation
Université du Québec à Chicoutimi (UQAC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hassan Ezzaidi, PhD
Organizational Affiliation
Université du Québec à Chicoutimi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed Bahoura, PhD
Organizational Affiliation
Université du Québec à Rimouski
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcos Parron, PhD
Organizational Affiliation
ISCAL - Londrina Santa Casa Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fahd Fahd Haddad, MD
Organizational Affiliation
ISCAL - Londrina Santa casa Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Colince Segning, MSc
Organizational Affiliation
Université du Québec à Chicoutimi
Official's Role
Study Chair
Facility Information:
Facility Name
Karen Fernandes
City
Londrina
State/Province
Parana
ZIP/Postal Code
86010929
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Fernandes, PhD
Phone
554399219493
Email
karenparron@gmail.com
First Name & Middle Initial & Last Name & Degree
Rubens da Silva, PhD
Phone
4185455011
Ext
4350
Email
rubens.dasilva@uqac.ca
First Name & Middle Initial & Last Name & Degree
Suzy Ngomo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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19787502
Citation
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Pfurtscheller G, Lopes da Silva FH. Event-related EEG/MEG synchronization and desynchronization: basic principles. Clin Neurophysiol. 1999 Nov;110(11):1842-57. doi: 10.1016/s1388-2457(99)00141-8.
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Pain Evaluation and Treatment in Clinical Settings

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