Pain Evaluation and Treatment in Clinical Settings

NCT05197777 | Unknown DMC

• 1 other identifier: 86.010-929
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Functional Limitations; Musculoskeletal Disorders

Keywords

Pain; EEG; TMS

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Muscle measurement by recording EMG signals (Units in microvolts μV)

  Change from baseline at 6 weeks

• Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz)

  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)

  Change from baseline at 6 weeks

Study Arms (2)

Group 1 : conservator physiotherapy

ACTIVE COMPARATOR

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

Other: Conservative physiotherapy

Group 2- tDCS associated to functional activities

EXPERIMENTAL

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

Interventions

tDCS associated to functional activities DEVICE

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.

Group 2- tDCS associated to functional activities

Conservative physiotherapy OTHER

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

Group 1 : conservator physiotherapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rubens da Silva: lead
• Londrina Santa casa Hospital: collaborator

Study Sites (1)

Karen Fernandes

Londrina, Paraná, 86010929, Brazil

Location

Related Publications (14)

• 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.

  PMID: 19787502 RESULT

• 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.

  PMID: 27707416 RESULT

• 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.

  PMID: 22954427 RESULT

• 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.

  PMID: 19379477 RESULT

• 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.

  PMID: 24355482 RESULT

• 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.

  PMID: 17071233 RESULT

• 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.

  PMID: 10576479 RESULT

• 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.

  PMID: 17353966 RESULT

• 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.

  PMID: 19376942 RESULT

• 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.

  PMID: 29321111 RESULT

• 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.

  PMID: 27014511 RESULT

• 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.

  PMID: 23087607 RESULT

• 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.

  PMID: 33669544 RESULT

• 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.

  PMID: 32205006 RESULT

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Diseases; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzy Ngomo, PhD

  Université du Québec à Chicoutimi (UQAC)

  STUDY DIRECTOR

• Hassan Ezzaidi, PhD

  Université du Québec à Chicoutimi

  STUDY CHAIR

• Mohamed Bahoura, PhD

  Université du Québec à Rimouski

  STUDY CHAIR

• Marcos Parron, PhD

  ISCAL - Londrina Santa Casa Hospital

  STUDY CHAIR

• Fahd Fahd Haddad, MD

  ISCAL - Londrina Santa casa Hospital

  STUDY CHAIR

• Colince Segning, MSc

  Université du Québec à Chicoutimi

  STUDY CHAIR

Central Study Contacts

Rubens Silva, PhD

CONTACT

4185455011; rubens.dasilva@uqac.ca

Karen Fernandes, PhD

CONTACT

554399219493; karenparron@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 19, 2022
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)