Chronic PainNCT05197777
Pain Evaluation and Treatment in Clinical Settings
A study testing tDCS associated to functional activities and Conservative physiotherapy in people with Chronic Pain and Functional Limitations, run by Rubens da Silva at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Pain, Functional Limitations, Musculoskeletal Disorders
- What is being tested?
- tDCS associated to functional activities and Conservative physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Karen Fernandes
Londrina, Paraná, 86010929
Karen Fernandes, PhD, 554399219493, karenparron@gmail.com
Rubens da Silva, PhD, 4185455011 ext. 4350, rubens.dasilva@uqac.ca
About this study
Official title: Innovations in Pain Assessment and Treatment for Individuals With Musculoskeletal Disorders: Brazil and Canada Collaboration
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.
Read more
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.
Read the 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.
- Being tested
- tDCS associated to functional activities, Conservative physiotherapy
- Keywords
- Pain, EEG, TMS
- Medical subject headings
- Chronic Pain, Musculoskeletal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS associated to functional activitiesDevice
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.
Conservative physiotherapyOther
Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : conservator physiotherapy | Active comparator | Education and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert. Receives: 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 Receives: Device: tDCS associated to functional activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and perception pain (score 1 to 10 numerical)
The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline at 6 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubens da Silva
- Sponsor type
- University, hospital or other
- Collaborators
- Londrina Santa casa Hospital
- Responsible party
- Sponsor-investigator, Rubens da Silva, Université du Québec à Chicoutimi
- Investigators
- Suzy Ngomo, PhD, Study director, Université du Québec à Chicoutimi (UQAC)Hassan Ezzaidi, PhD, Study chair, Université du Québec à ChicoutimiMohamed Bahoura, PhD, Study chair, Université du Québec à RimouskiMarcos Parron, PhD, Study chair, ISCAL - Londrina Santa Casa HospitalFahd Fahd Haddad, MD, Study chair, ISCAL - Londrina Santa casa HospitalColince Segning, MSc, Study chair, Université du Québec à Chicoutimi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197777
- Sponsor's protocol ID
- 86.010-929
- Status last verified
- May 2023
- First submitted
- 19 Nov 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19787502Mahdavi 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.
PubMed 27707416Srinivasan 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.
PubMed 22954427Leboeuf-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.
PubMed 19379477Nasseroleslami 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.
PubMed 24355482Neuper 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.
PubMed 17071233Pfurtscheller 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.
PubMed 10576479Descatha 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.
PubMed 17353966Descatha 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.
PubMed 19376942Karcioglu 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.
PubMed 29321111Maskeliunas 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.
PubMed 27014511Wang 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.
PubMed 23087607Segning 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.
PubMed 33669544Desbiens 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.
PubMed 32205006
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in Pain Assessment and Treatment for Individuals With Musculoskeletal Disorders: Brazil and Canada Collaboration
- ClinicalTrials.gov ID
- NCT05197777
- Acronym / sponsor ID
- 86.010-929
- Keywords
- Pain, EEG, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rubens da SilvaUniversity, hospital or other
- Collaborators
- Londrina Santa casa Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : conservator physiotherapy | Active comparator | Other: Conservative physiotherapyEducation and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert. |
| Group 2- tDCS associated to functional activities | Experimental | Device: tDCS associated to functional activitiesThe 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- Cancer
- Red flags (infection, tumor, etc.)
- Severe psychiatric disorders
- Palliative care
- Congenital spinal deformity (spondylolysis, intervertebral fusions, 4 lumbar vertebrae)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS associated to functional activitiesThe 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. | Device | Group 2- tDCS associated to functional activities |
| Conservative physiotherapyEducation and exercices for pain relief by usual tradicional physiotherapy in Hospital: walking, mobility, and transfert. | Other | Group 1 : conservator physiotherapy |
Primary outcome
Subjective and perception pain (score 1 to 10 numerical)
Time frame: Change from baseline at 6 weeks
The 0 (minimal) to 10 (maximal) numerical Rating Scales (NRS)
Subjective and perception pain (score total)
Time frame: Change from baseline at 6 weeks
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)
Time frame: Change from baseline at 6 weeks
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).
Time frame: Change from baseline at 6 weeks
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)
Time frame: Change from baseline at 6 weeks
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)
Time frame: Change from baseline at 6 weeks
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)
Time frame: Change from baseline at 6 weeks
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.
3 secondary outcomes
Muscle measurement by recording EMG signals (Units in microvolts μV)
Time frame: Change from baseline at 6 weeks
Brain measurement by recording EEG signals (Units in microvolts μV and frequency in Hz)
Time frame: 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)
Time frame: Change from baseline at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Results publication: PubMed 19787502Nordander 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.
- Results publication: PubMed 27707416Mahdavi 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.
- Results publication: PubMed 22954427Srinivasan 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.
- Results publication: PubMed 19379477Leboeuf-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.
- Results publication: PubMed 24355482Nasseroleslami 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.
- Results publication: PubMed 17071233Neuper 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.
- Results publication: PubMed 10576479Pfurtscheller 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.
- Results publication: PubMed 17353966Descatha 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.
- Results publication: PubMed 19376942Descatha 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.
- Results publication: PubMed 29321111Karcioglu 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.
- Results publication: PubMed 27014511Maskeliunas 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.
- Results publication: PubMed 23087607Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzy Ngomo, PhD study director
Université du Québec à Chicoutimi (UQAC)
Hassan Ezzaidi, PhD study chair
Université du Québec à Chicoutimi
Mohamed Bahoura, PhD study chair
Université du Québec à Rimouski
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS associated to functional activities and Conservative physiotherapy in people with Chronic Pain and Functional Limitations, run by Rubens da Silva at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens Silva, PhD (4185455011 ext. 6123, rubens.dasilva@uqac.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective and perception pain (score 1 to 10 numerical) (time frame: Change from baseline at 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197777, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.