Muscle FatigueNCT03863340
Short Interventions to Prevent Trapezius Muscle Fatigue in Computer Work
A study testing interruptions of work tasks in people with Muscle Fatigue and Trapezius Muscle Strain, run by Swiss Federal Institute of Technology.
Trial summary
This study is expected to demonstrate that during experimental days of seated computer work sustained and focalized low-level muscle activity contributes to the development of long-lasting fatigue effects (and thus possible disorder). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue, Trapezius Muscle Strain
- What is being tested?
- interruptions of work tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2016to 5 Sep 2016
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy experienced computer workers
Who cannot join
- chronic pain (more than 30 days within the last 12 months according to the Nordic Questionnaire (Kuorinka et al 1987);
- pathologies of the neck,
- prior and actual shoulder or neck pain caused by an accident,
- skin disease in the neck or shoulder area,
- BMI > 30,
- sleep disorders (e.g. apnea, restless legs syndrome),
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- use of medications such as psychotropic drugs, muscle relaxants or analgesics within the last 3 days prior to the experiment,
- pregnancy.
- any shoulder/neck pain on the day before the experiment.
About this study
Official title: Trapezius Muscle Fatigue of Long Duration: a Likely Neuromuscular Control Issue
This study is expected to demonstrate that during experimental days of seated computer work sustained and focalized low-level muscle activity contributes to the development of long-lasting fatigue effects (and thus possible disorder). On days with and without frequent interruptions, signs of fatigue and the activity pattern of the trapeze muscle are registered and compared using electromyographic registrations of the trapezius muscle.
Read the detailed description
30 healthy adults without chronic neck pain participated in a laboratory study designed to simulate two full workdays of computer work. Within each session, participants performed five 50-min working activities separated by 10-min breaks: i) Use a computer keyboard to type a text presented on the left side of the screen; ii) do the typing task with the desk height set10 cm above elbow height; iii) play the computer game Spider Solitaire implemented in Windows 10; iv) Stroop test (This test consists of reading the name of a color whose text is in a color different from the name. The color name was then selected from a multiple-choice panel displaying color names; v) the same online puzzle game was presented to all participants. Assembling the puzzle was performed by drag and drop actions. The work periods were not disrupted (on the "control day") whereas two short interruptions of 5-min were introduced at 1/3 and 2/3 of each working period on the "intervention day". During these interruptions, participants were asked to perform "muscle disrupting/relaxing" activities. For each experimental session a 30-min lunch break took place between the third and the fourth work periods. The specific sequence of work activity type and disrupting/relaxing activities was randomized across participants; however, for each participant the order of work activities remained the same for the two experimental sessions (control and intervention days). The order of control and intervention days was also randomized between participants.
A set of six measures were performed at specific time intervals during each experiment: before the first work activity, before and after lunch, immediately and 1 hour after the fifth (last) work activity: i) upper trapezius activation, assessed through the temporal EMG profile recorded by a single bipolar signal; and ii) through the spatio-temporal distribution of EMG activity detected by a 2D array of electrodes (64 channels); iii) muscle fatigue, quantified by changes in electrically induced muscle twitch force signals, iv) isometric performance, v) dynamic performance; iii) cognitive and physical load and stress level. In addition, personality traits (anxiety level), perceived workload and musculoskeletal symptoms were evaluated as covariates.
- Conditions
- Muscle Fatigue, Trapezius Muscle Strain
- Being tested
- interruptions of work tasks
- Keywords
- muscle fatigue, work-related disorders, trapezius myalgia, sustained working task, high-density EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interruptions of work tasksBehavioural
During each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions:
Active break types:
- Move shoulder and upper back
- Swing arms near the body
- Three slow but forceful elevations of the shoulders, a relaxation exercise based on the principles developed by Jacobson
- Stand up and stretch
- Slowly turn head in all possible directions.
Passive break types:
- Tell a couple of jokes
- Stand up and have a drink
- Relaxing the trapezius
- Questions on actual posture and feelings of comfort / discomfort.
- A short rest on the couch
| Study group | Role | What they receive |
|---|---|---|
| short interruptions of work tasks | Experimental | randomly start with or without short interruptions on the first experimental day and without or with them on the second experimental day Receives: Behavioral: interruptions of work tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG profile recorded by a single bipolar electrode: Rest-time
Rest-time (percentage of time below 5% of the standard activity level). The percentage of registration time without any rest time is called sustained low level muscle activity.
Measured: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Spatio-temporal distribution of EMG activity: Area of muscle activity
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined:
Area of muscle active region (n. of channels)
Measured: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of muscle twitch
3-D muscle twitch acceleration pattern measured at the acromion
Measured: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of dynamic force control accuracy
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in an isometric dynamic tracking task
Measured: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Secondary outcomes (5)
EMG profile recorded by a single bipolar electrode: Static activity
p10 (level of the 10th percentile of the trapezius muscle activity) as an indicator of static activity primarily associated with continuous activity of the same pool of motor units.
Measured: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Spatio-temporal distribution of EMG activity: Magnitude of activity
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined:
Magnitude of activity of muscle active regions (RMS sEMG).
Measured: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Spatio-temporal distribution of EMG activity: Number of active epochs
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Number of active epochs
Measured: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of static force control
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric isotonic low level contraction
Measured: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of force control in ramp contraction
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric ramp contraction.
Measured: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start14 Mar 2016
- Primary completion5 Sep 2016
- Study completion5 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies 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
- Prevention
- Intervention model
- Sequential
- Model description
- Randomized controlled laboratory experiment. 30 subjects are randomly assigned to two full day experiments either starting with the conditions including additional short interventions or without them.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy, University of Lausanne, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Thomas Läubli, MD, Principal investigator, Federal Institute of Technology Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863340
- Sponsor's protocol ID
- 32003B_160207
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapezius Muscle Fatigue of Long Duration: a Likely Neuromuscular Control Issue
- ClinicalTrials.gov ID
- NCT03863340
- Acronym / sponsor ID
- 32003B_160207
- Conditions
- Muscle Fatigue, Trapezius Muscle Strain
- Keywords
- muscle fatigue, work-related disorders, trapezius myalgia, sustained working task, high-density EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Turin, Italy, University of Lausanne, University of Michigan
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 5 Sep 2016 (actual)
- Study completion
- 5 Sep 2016 (actual)
- First posted
- 5 Mar 2019 (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 study is expected to demonstrate that during experimental days of seated computer work sustained and focalized low-level muscle activity contributes to the development of long-lasting fatigue effects (and thus possible disorder). On days with and without frequent interruptions, signs of fatigue and the activity pattern of the trapeze muscle are registered and compared using electromyographic registrations of the trapezius muscle.
Detailed description
30 healthy adults without chronic neck pain participated in a laboratory study designed to simulate two full workdays of computer work. Within each session, participants performed five 50-min working activities separated by 10-min breaks: i) Use a computer keyboard to type a text presented on the left side of the screen; ii) do the typing task with the desk height set10 cm above elbow height; iii) play the computer game Spider Solitaire implemented in Windows 10; iv) Stroop test (This test consists of reading the name of a color whose text is in a color different from the name. The color name was then selected from a multiple-choice panel displaying color names; v) the same online puzzle game was presented to all participants. Assembling the puzzle was performed by drag and drop actions. The work periods were not disrupted (on the "control day") whereas two short interruptions of 5-min were introduced at 1/3 and 2/3 of each working period on the "intervention day". During these interruptions, participants were asked to perform "muscle disrupting/relaxing" activities. For each experimental session a 30-min lunch break took place between the third and the fourth work periods. The specific sequence of work activity type and disrupting/relaxing activities was randomized across participants; however, for each participant the order of work activities remained the same for the two experimental sessions (control and intervention days). The order of control and intervention days was also randomized between participants.
A set of six measures were performed at specific time intervals during each experiment: before the first work activity, before and after lunch, immediately and 1 hour after the fifth (last) work activity: i) upper trapezius activation, assessed through the temporal EMG profile recorded by a single bipolar signal; and ii) through the spatio-temporal distribution of EMG activity detected by a 2D array of electrodes (64 channels); iii) muscle fatigue, quantified by changes in electrically induced muscle twitch force signals, iv) isometric performance, v) dynamic performance; iii) cognitive and physical load and stress level. In addition, personality traits (anxiety level), perceived workload and musculoskeletal symptoms were evaluated as covariates.
Study design
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized controlled laboratory experiment. 30 subjects are randomly assigned to two full day experiments either starting with the conditions including additional short interventions or without them.
| Arm | Type | Receives |
|---|---|---|
| short interruptions of work tasks | Experimental | Behavioral: interruptions of work tasksrandomly start with or without short interruptions on the first experimental day and without or with them on the second experimental day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy experienced computer workers
Key exclusion criteria (9 listed)
- chronic pain (more than 30 days within the last 12 months according to the Nordic Questionnaire (Kuorinka et al 1987);
- pathologies of the neck,
- prior and actual shoulder or neck pain caused by an accident,
- skin disease in the neck or shoulder area,
- BMI > 30,
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 |
|---|---|---|
| interruptions of work tasksDuring each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions: Active break types: * Move shoulder and upper back * Swing arms near the body * Three slow but forceful elevations of the shoulders, a relaxation exercise based on the principles developed by Jacobson * Stand up and stretch * Slowly turn head in all possible directions. Passive break types: * Tell a couple of jokes * Stand up and have a drink * Relaxing the trapezius * Questions on actual posture and feelings of comfort / discomfort. * A short rest on the couch | Behavioural | short interruptions of work tasks |
Primary outcome
EMG profile recorded by a single bipolar electrode: Rest-time
Time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Rest-time (percentage of time below 5% of the standard activity level). The percentage of registration time without any rest time is called sustained low level muscle activity.
Spatio-temporal distribution of EMG activity: Area of muscle activity
Time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Area of muscle active region (n. of channels)
Muscle fatigue: Change of muscle twitch
Time frame: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
3-D muscle twitch acceleration pattern measured at the acromion
Muscle fatigue: Change of dynamic force control accuracy
Time frame: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in an isometric dynamic tracking task
5 secondary outcomes
EMG profile recorded by a single bipolar electrode: Static activity
Time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Spatio-temporal distribution of EMG activity: Magnitude of activity
Time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Spatio-temporal distribution of EMG activity: Number of active epochs
Time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of static force control
Time frame: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Muscle fatigue: Change of force control in ramp contraction
Time frame: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
Thomas Läubli, MD principal investigator
Federal Institute of Technology Zurich
Questions about this trial
What is this clinical trial studying?
A study testing interruptions of work tasks in people with Muscle Fatigue and Trapezius Muscle Strain, run by Swiss Federal Institute of Technology.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG profile recorded by a single bipolar electrode: Rest-time (time frame: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2019.