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Pain Evaluation and Treatment in Clinical Settings

Studies

Study First Submitted Date 2021-11-19
Study First Posted Date 2022-01-19
Last Update Posted Date 2023-05-10
Start Month Year November 1, 2023
Primary Completion Month Year December 31, 2024
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-10

Detailed Descriptions

Sequence: 20841899
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.

Facilities

Sequence: 201200380
Name Karen Fernandes
City Londrina
State Parana
Zip 86010929
Country Brazil

Facility Contacts

Sequence: 28268172 Sequence: 28268173
Facility Id 201200380 Facility Id 201200380
Contact Type primary Contact Type backup
Name Karen Fernandes, PhD Name Rubens da Silva, PhD
Email karenparron@gmail.com Email rubens.dasilva@uqac.ca
Phone 554399219493 Phone 4185455011
Phone Extension 4350

Facility Investigators

Sequence: 18431030
Facility Id 201200380
Role Principal Investigator
Name Suzy Ngomo, PhD

Conditions

Sequence: 52479342 Sequence: 52479343 Sequence: 52479344
Name Chronic Pain Name Functional Limitations Name Musculoskeletal Disorders
Downcase Name chronic pain Downcase Name functional limitations Downcase Name musculoskeletal disorders

Id Information

Sequence: 40379248
Id Source org_study_id
Id Value 86.010-929

Countries

Sequence: 42814953
Name Brazil
Removed False

Design Groups

Sequence: 55935405 Sequence: 55935406
Group Type Active Comparator Group Type Experimental
Title Group 1 : conservator physiotherapy Title Group 2- tDCS associated to functional activities
Description Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert. 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

Interventions

Sequence: 52789128 Sequence: 52789129
Intervention Type Device Intervention Type Other
Name tDCS associated to functional activities Name Conservative physiotherapy
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. Description Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.

Keywords

Sequence: 80287118 Sequence: 80287119 Sequence: 80287120
Name Pain Name EEG Name TMS
Downcase Name pain Downcase Name eeg Downcase Name tms

Design Outcomes

Sequence: 178535027 Sequence: 178535028 Sequence: 178535029 Sequence: 178535030 Sequence: 178535031 Sequence: 178535032 Sequence: 178535033 Sequence: 178535034 Sequence: 178535035 Sequence: 178535036
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Subjective and perception pain (score 1 to 10 numerical) Measure Subjective and perception pain (score total) Measure Objective pain by algometer (units in kgf) Measure Functional test #1 – The sitting-rising test (SRT; unit number of support from 10 to 1). Measure Functional test #2 – Five Times Sit-to-Stand Test (Unit time in seconds) Measure Functional test #3 Timed Up and Go test (TUG, unit time in seconds) Measure Nordic Musculoskeletal Questionnaire (NMQ) Measure Muscle measurement by recording EMG signals (Units in microvolts μV) Measure Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz) Measure Cortical excitability was assessed with the resting motor threshold (rMT) using a Transcranial Magnetic Stimulator (Units in microvolts μV)
Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks Time Frame Change from baseline at 6 weeks
Description The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS) 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 Description Algometer measurement for assessing the pressure pain threshold using a digital device in kgf. 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. 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 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. 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. 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 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 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.

Browse Conditions

Sequence: 194664043 Sequence: 194664044 Sequence: 194664045 Sequence: 194664046
Mesh Term Musculoskeletal Diseases Mesh Term Chronic Pain Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term chronic pain Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48605652 Sequence: 48605653
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Rubens da Silva Name Londrina Santa casa Hospital

Overall Officials

Sequence: 29446898 Sequence: 29446899 Sequence: 29446900 Sequence: 29446901 Sequence: 29446902 Sequence: 29446903
Role Study Director Role Study Chair Role Study Chair Role Study Chair Role Study Chair Role Study Chair
Name Suzy Ngomo, PhD Name Hassan Ezzaidi, PhD Name Mohamed Bahoura, PhD Name Marcos Parron, PhD Name Fahd Fahd Haddad, MD Name Colince Segning, MSc
Affiliation Université du Québec à Chicoutimi (UQAC) Affiliation Université du Québec à Chicoutimi Affiliation Université du Québec à Rimouski Affiliation ISCAL – Londrina Santa Casa Hospital Affiliation ISCAL – Londrina Santa casa Hospital Affiliation Université du Québec à Chicoutimi

Central Contacts

Sequence: 12087931 Sequence: 12087932
Contact Type primary Contact Type backup
Name Rubens Silva, PhD Name Karen Fernandes, PhD
Phone 4185455011 Phone 554399219493
Email rubens.dasilva@uqac.ca Email karenparron@gmail.com
Phone Extension 6123
Role Contact Role Contact

Design Group Interventions

Sequence: 68571238 Sequence: 68571239
Design Group Id 55935406 Design Group Id 55935405
Intervention Id 52789128 Intervention Id 52789129

Eligibilities

Sequence: 30942146
Gender All
Minimum Age 20 Years
Maximum Age 85 Years
Healthy Volunteers No
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254282644
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Maximum Age Num 85
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 7
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30687756
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Investigator Masked True

Responsible Parties

Sequence: 29054493
Responsible Party Type Sponsor-Investigator
Name Rubens da Silva
Title Professor
Affiliation Université du Québec à Chicoutimi

Study References

Sequence: 52388706 Sequence: 52388707 Sequence: 52388708 Sequence: 52388709 Sequence: 52388710 Sequence: 52388711 Sequence: 52388712 Sequence: 52388713 Sequence: 52388714 Sequence: 52388715 Sequence: 52388716 Sequence: 52388717 Sequence: 52388718 Sequence: 52388719
Pmid 19787502 Pmid 27707416 Pmid 22954427 Pmid 19379477 Pmid 24355482 Pmid 17071233 Pmid 10576479 Pmid 17353966 Pmid 19376942 Pmid 29321111 Pmid 27014511 Pmid 23087607 Pmid 33669544 Pmid 32205006
Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
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, Avon). 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.