Pain Evaluation and Treatment in Clinical Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innovations in Pain Assessment and Treatment for Individuals With Musculoskeletal Disorders: Brazil and Canada Collaboration

Conditions
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Chronic Pain, Functional Limitations, Musculoskeletal Disorders

Intervention / Treatment
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* Device: tDCS associated to functional activities
* Other: Conservative physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 : conservator physiotherapy<br>Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert. | Other: Conservative physiotherapy<br>* Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.<br>|
| Experimental: Group 2- tDCS associated to functional activities<br>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 | Device: tDCS associated to functional activities<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective and perception pain (score 1 to 10 numerical) | The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS) | Change from baseline at 6 weeks | 
| 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 | Change from baseline at 6 weeks | 
| Objective pain by algometer (units in kgf) | Algometer measurement for assessing the pressure pain threshold using a digital device in kgf. | Change from baseline at 6 weeks | 
| 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. | Change from baseline at 6 weeks | 
| 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 | Change from baseline at 6 weeks | 
| 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. | Change from baseline at 6 weeks | 
| 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. | Change from baseline at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline at 6 weeks | 
| 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 | Change from baseline at 6 weeks | 
| 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. | Change from baseline at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, EEG, TMS