Clinical trial NCT05197777: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Functional Limitations
Musculoskeletal Disorders
Keywords: Pain
EEG
TMS
Lead sponsor: Université du Québec à Chicoutimi
Sponsor class: OTHER
Collaborators: name: Londrina Santa casa Hospital
First posted: 2022-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective and perception pain (score 1 to 10 numerical)
timeFrame: Change from baseline at 6 weeks
measure: Subjective and perception pain (score total)
timeFrame: Change from baseline at 6 weeks
measure: Objective pain by algometer (units in kgf)
timeFrame: Change from baseline at 6 weeks
measure: Functional test #1 - The sitting-rising test (SRT; unit number of support from 10 to 1).
timeFrame: Change from baseline at 6 weeks
measure: Functional test #2 - Five Times Sit-to-Stand Test (Unit time in seconds)
timeFrame: Change from baseline at 6 weeks
measure: Functional test #3 Timed Up and Go test (TUG, unit time in seconds)
timeFrame: Change from baseline at 6 weeks
measure: Nordic Musculoskeletal Questionnaire (NMQ)
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Muscle measurement by recording EMG signals (Units in microvolts μV)
timeFrame: Change from baseline at 6 weeks
measure: Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz)
timeFrame: Change from baseline at 6 weeks
measure: Cortical excitability was assessed with the resting motor threshold (rMT) using a Transcranial Magnetic Stimulator (Units in microvolts μV)
timeFrame: Change from baseline at 6 weeks
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Karen Fernandes
state: Parana
Study officials:
affiliation: Université du Québec à Chicoutimi (UQAC)
name: Suzy Ngomo, PhD
role: STUDY_DIRECTOR
affiliation: Université du Québec à Chicoutimi
name: Hassan Ezzaidi, PhD
role: STUDY_CHAIR
affiliation: Université du Québec à Rimouski
name: Mohamed Bahoura, PhD
role: STUDY_CHAIR
affiliation: ISCAL - Londrina Santa Casa Hospital
name: Marcos Parron, PhD
role: STUDY_CHAIR
affiliation: ISCAL - Londrina Santa casa Hospital
name: Fahd Fahd Haddad, MD
role: STUDY_CHAIR
affiliation: Université du Québec à Chicoutimi
name: Colince Segning, MSc
role: STUDY_CHAIR
References:
citation: Nordander C, Ohlsson K, Akesson I, Arvidsson I, Balogh I, Hansson GA, Stromberg U, Rittner R, Skerfving S. Risk of musculoskeletal disorders among females and males in repetitive/constrained work. Ergonomics. 2009 Oct;52(10):1226-39. doi: 10.1080/00140130903056071.
citation: Mahdavi N, Motamedzade M, Jamshidi AA, Darvishi E, Moghimbeygi A, Heidari Moghadam R. Upper trapezius fatigue in carpet weaving: the impact of a repetitive task cycle. Int J Occup Saf Ergon. 2018 Mar;24(1):41-51. doi: 10.1080/10803548.2016.1234706. Epub 2016 Oct 6.
citation: Srinivasan D, Mathiassen SE. Motor variability in occupational health and performance. Clin Biomech (Bristol). 2012 Dec;27(10):979-93. doi: 10.1016/j.clinbiomech.2012.08.007. Epub 2012 Sep 4.
citation: Leboeuf-Yde C, Nielsen J, Kyvik KO, Fejer R, Hartvigsen J. Pain in the lumbar, thoracic or cervical regions: do age and gender matter? A population-based study of 34,902 Danish twins 20-71 years of age. BMC Musculoskelet Disord. 2009 Apr 20;10:39. doi: 10.1186/1471-2474-10-39.
citation: Nasseroleslami B, Lakany H, Conway BA. EEG signatures of arm isometric exertions in preparation, planning and execution. Neuroimage. 2014 Apr 15;90:1-14. doi: 10.1016/j.neuroimage.2013.12.011. Epub 2013 Dec 16.
citation: Neuper C, Wortz M, Pfurtscheller G. ERD/ERS patterns reflecting sensorimotor activation and deactivation. Prog Brain Res. 2006;159:211-22. doi: 10.1016/S0079-6123(06)59014-4.
citation: 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.
citation: Descatha A, Roquelaure Y, Chastang JF, Evanoff B, Melchior M, Mariot C, Ha C, Imbernon E, Goldberg M, Leclerc A. Validity of Nordic-style questionnaires in the surveillance of upper-limb work-related musculoskeletal disorders. Scand J Work Environ Health. 2007 Feb;33(1):58-65. doi: 10.5271/sjweh.1065.
citation: Descatha A, Roquelaure Y, Chastang JF, Evanoff B, Cyr D, Leclerc A. Work, a prognosis factor for upper extremity musculoskeletal disorders? Occup Environ Med. 2009 May;66(5):351-2. doi: 10.1136/oem.2008.042630. No abstract available.
citation: Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.
citation: Maskeliunas R, Damasevicius R, Martisius I, Vasiljevas M. Consumer-grade EEG devices: are they usable for control tasks? PeerJ. 2016 Mar 22;4:e1746. doi: 10.7717/peerj.1746. eCollection 2016.
citation: Wang D, Miao D, Blohm G. Multi-class motor imagery EEG decoding for brain-computer interfaces. Front Neurosci. 2012 Oct 9;6:151. doi: 10.3389/fnins.2012.00151. eCollection 2012.
citation: Segning CM, Ezzaidi H, da Silva RA, Ngomo S. A Neurophysiological Pattern as a Precursor of Work-Related Musculoskeletal Disorders Using EEG Combined with EMG. Int J Environ Res Public Health. 2021 Feb 19;18(4):2001. doi: 10.3390/ijerph18042001.
citation: Desbiens S, Girardin-Rondeau M, Guyot-Messier L, Lamoureux D, Paris L, da Silva RA, Ngomo S. Effect of transcranial direct stimulation combined with a functional task on fibromyalgia pain: A case study. Neurophysiol Clin. 2020 Apr;50(2):134-137. doi: 10.1016/j.neucli.2020.02.006. Epub 2020 Mar 20. No abstract available.