Work-related Musculoskeletal DisordersNCT04198675

Effects of Preventive Physiotherapy Practices on Posture and Work-Related Functions in Office Workers

A study testing Supervised EMG Biofeedback Exercise Training Group, Home-Based Exercise Training Group and Posture Training/Ergonomic Regulations Group in people with Work-related Musculoskeletal Disorders and Office Workers, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

In this study; aimed to determine an individual-centered, effective physiotherapy method to reduce the negative impacts of the forward head posture on work-related functions and to increase body awareness and functionality among office workers. Read more about this study

Who is it for?: Ages 22 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Work-related Musculoskeletal Disorders, Office Workers
What is being tested?: Supervised EMG Biofeedback Exercise Training Group, Home-Based Exercise Training Group and Posture Training/Ergonomic Regulations Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 26 Aug 2019to 13 Sep 2021
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 22 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age below 40, Full-time and regular employees in the last 1 year,
Office workers using computers at desk for at least 3 hours per day
According to RULA, working in a posture that above acceptable level,
No trauma history
Non-specific neck pain but no chronic conditions of cervical spine and upper extremity

Who cannot join

During the study; need of receiving a treatment/ interventions for the upper body due to trauma or any other conditions is concluded with withdraw from the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University Faculty of Health Sciences
Maltepe, Istanbul, 1464185881

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Preventive Physiotherapy Practices on Forward Head Posture and Upper Extremity Work-Related Functions in Office Workers

Read the detailed description

The purpose of this study is to determine the effects of preventive physiotherapy practices on work related musculoskeletal disorders in office workers.

With this purpose, in this study; aimed to achieve improvement on forward head posture, upper extremity functions and cervical pain reduction through three interventions (supervised EMG biofeedback exercise training, home-based exercise program and posture training/ergonomic regulations). Work related changes in muscle activation of Upper Trapezius and posture will be evaluated while working on a computer task in actual work environment. Differences in posture and muscle activation between computer task and resting position, will be determined before and after the intervention.

Conditions: Work-related Musculoskeletal Disorders, Office Workers
Being tested: Supervised EMG Biofeedback Exercise Training Group, Home-Based Exercise Training Group, Posture Training/Ergonomic Regulations Group
Keywords: Surface Electromyography, Biofeedback, Forward Head Posture, Posture, Trapezius Muscle, Task- specific Performance, Exercise, Office Worker
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supervised EMG Biofeedback Exercise Training GroupBehavioural
Posture training and ergonomic arrangements in the workplace. EMG biofeedback training will be carried out with electromyography-controlled video game combined with PNF exercises. Each game sessions comprising the work-rest cycle covers performing the upper trapezius muscle contraction simultaneously the upper extremity PNF patterns.
Home-Based Exercise Training GroupBehavioural
Posture training and ergonomic arrangements in the workplace. Posture correction exercises, contains strengthening, stretching, mobility and relaxation exercises, will be given as a home exercises program. Exercise diary and weekly calls will be use to maintain the exercise adherence
Posture Training/Ergonomic Regulations GroupBehavioural
Posture training and ergonomic arrangements in the workplace.

Study groups in NCT04198675
Study group	Role	What they receive
Supervised EMG Biofeedback Exercise Training Group	Active comparator	Frequency: 3/week Duration:6 weeks Dosage: Tolerable intensity-dependent increase in exercises program. Receives: Behavioral: Supervised EMG Biofeedback Exercise Training Group
Home-Based Exercise Training Group	Active comparator	Frequency: 3/week Duration:6 weeks Dosage: Tolerable intensity-dependent increase in exercises program. Receives: Behavioral: Home-Based Exercise Training Group
Posture Training/Ergonomic Regulations Group	Sham comparator	1 session, no further intervention until second evaluation for 6 weeks. Receives: Behavioral: Posture Training/Ergonomic Regulations Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximal Voluntary Isometric Contraction (MVIC)
It is assessed by Surface Electromyography (sEMG) for upper trapezius muscle. 3 maximum contractions are performed for 6 seconds at the manual muscle testing position. The maximum value among 3 repeats is recorded as Maximal Voluntary Isometric Contraction (MVIC) (mV).
Measured: 10 minutes
Muscle Activation of Upper Trapezius
It is the measurement of the Electromyographic activity of trapezius muscles during functional tasks and rest. According to The Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles Project (SENIAM) recommendations for sensors and sensor placement procedures, sEMG will be applied for the upper trapezius muscles while resting and also performing the computer task in workplace. The mean values (mV) obtained are normalized according to MVIC. Normalized data (%MVIC) are used in the statistical analysis.
Measured: 30 minutes
Cervical Range of Motion (CROM) / Forward Head Posture
The CROM Deluxe is an assessment instrument that lets to measure sagittal, frontal and horizontal plane movements (flexion / extension, lateral flexion, rotation and forward head posture), while resting and also performing a task or work posture.
Measured: 10 minutes

Secondary outcomes (6)

Constant-Murley Score (CMS)
The Constant-Murley Score (CMS) is a widely used scale to measure pain, mobility and the ability to carry out the normal daily activities in various shoulder conditions/ pathologies.
Measured: 10 minutes
Rapid Upper Limb Assessment (RULA)
The RULA Assessment Tool is used to evaluate the ergonomic risk factors associated with neck, trunk and upper extremity Musculoskeletal Disorders (MSD). The RULA considers biomechanical and postural load requirements of job demands. Scores between 1-7 are classified from "acceptable posture" (no action required) to "very high risk" (implement change now).
Measured: 10 minutes
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
The DASH is a self reported questionnaire; assesses the parameters of daily life, pain, weakness, social functions, work, sleep and self-confidence associated with the upper extremity of the individual.
Measured: 10 minutes
The Disabilities of the Arm, Shoulder and Hand Score Work Module (DASH-W)
Work Module (DASH-W) is the second part of the DASH questionnaire, which consists of 4 questions, determines one's disability in working life.
Measured: 2 minutes
Neck Disability Index (NDI)
The NDI is a self-reported scale consists of pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and leisure time activities sections. The total score varies between 0-50 and the increase in total score indicates the increase in the severity of the neck disability.
Measured: 10 minutes
Neck Pain and Disability Scale (NPAD)
The NPAD is a self-reported index which measure the intensity of neck pain during different conditions and activities and related effects of pain on occupational, recreational, social, daily living activities and its relationship with emotional factors. Pain-related data are obtained by marking on visual analogue scales of 20 items.
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 201913 Sep 2021

First posted13 Dec 2019
Study start26 Aug 2019
Primary completion15 Feb 2020
Study completion13 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Work-related Musculoskeletal DisordersStudies of the same condition, open and under way.
More trials run by Marmara UniversityThe sponsor's other registered studies.
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
Allocation: Randomised
Intervention model: Parallel groups
Model description: Group 1: Supervised EMG Biofeedback Exercise Training Group; Posture training will be provided before intervention and ergonomic arrangements will be made in the workplace. Three sessions per week and six weeks of EMG biofeedback training will be carried out with electromyography-controlled video game combined with Proprioceptive Neuromuscular Facilitation (PNF) exercises. Group 2: Home-Based Exercise Training Group; Posture training will be provided before interventions and ergonomic arrangements will be made in the workplace. Posture correction exercises, contains strengthening, stretching, mobility and relaxation exercises, will be given as a home exercises program for 6 weeks. Group 3: Posture Training/Ergonomic Regulations Group Posture training will be provided before interventions and ergonomic arrangements will be made in the workplace.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04198675
Sponsor's protocol ID: 09.2018.282
Status last verified: Apr 2022
First submitted: 1 Sep 2019
Last updated: 14 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Exercise and Health Education for Musculoskeletal Health in Industrial Workers
Work-Related Musculoskeletal Disorders
Not yet recruiting
Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback
Work-Related Musculoskeletal Disorders
Not yet recruitingObservational study
National Survey of Chronic Occupational Pain in Thai Anesthesia Providers
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET®
Musculoskeletal Diseases or Conditions
Not yet recruitingObservational study
A Digital Ergonomics Assessment of Work-related Musculoskeletal Disorders Risk Between Female and Male Physical Therapists.
Musculoskeletal Disorder

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Preventive Physiotherapy Practices on Forward Head Posture and Upper Extremity Work-Related Functions in Office Workers
ClinicalTrials.gov ID: NCT04198675
Acronym / sponsor ID: 09.2018.282
Conditions: Work-related Musculoskeletal Disorders, Office Workers
Keywords: Surface Electromyography, Biofeedback, Forward Head Posture, Posture, Trapezius Muscle, Task- specific Performance, Exercise, Office Worker
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 26 Aug 2019 (actual)
Primary completion: 15 Feb 2020 (actual)
Study completion: 13 Sep 2021 (actual)
First posted: 13 Dec 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.

Detailed description

The purpose of this study is to determine the effects of preventive physiotherapy practices on work related musculoskeletal disorders in office workers.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Group 1: Supervised EMG Biofeedback Exercise Training Group; Posture training will be provided before intervention and ergonomic arrangements will be made in the workplace. Three sessions per week and six weeks of EMG biofeedback training will be carried out with electromyography-controlled video game combined with Proprioceptive Neuromuscular Facilitation (PNF) exercises. Group 2: Home-Based Exercise Training Group; Posture training will be provided before interventions and ergonomic arrangements will be made in the workplace. Posture correction exercises, contains strengthening, stretching, mobility and relaxation exercises, will be given as a home exercises program for 6 weeks. Group 3: Posture Training/Ergonomic Regulations Group Posture training will be provided before interventions and ergonomic arrangements will be made in the workplace.

Arm	Type	Receives
Supervised EMG Biofeedback Exercise Training Group	Active comparator	Behavioral: Supervised EMG Biofeedback Exercise Training GroupFrequency: 3/week Duration:6 weeks Dosage: Tolerable intensity-dependent increase in exercises program.
Home-Based Exercise Training Group	Active comparator	Behavioral: Home-Based Exercise Training GroupFrequency: 3/week Duration:6 weeks Dosage: Tolerable intensity-dependent increase in exercises program.
Posture Training/Ergonomic Regulations Group	Sham comparator	Behavioral: Posture Training/Ergonomic Regulations Group1 session, no further intervention until second evaluation for 6 weeks.

Who may qualify

Ages: 22 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age below 40, Full-time and regular employees in the last 1 year,
Office workers using computers at desk for at least 3 hours per day
According to RULA, working in a posture that above acceptable level,
No trauma history
Non-specific neck pain but no chronic conditions of cervical spine and upper extremity

Key exclusion criteria (1 listed)

During the study; need of receiving a treatment/ interventions for the upper body due to trauma or any other conditions is concluded with withdraw from the study

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
Supervised EMG Biofeedback Exercise Training GroupPosture training and ergonomic arrangements in the workplace. EMG biofeedback training will be carried out with electromyography-controlled video game combined with PNF exercises. Each game sessions comprising the work-rest cycle covers performing the upper trapezius muscle contraction simultaneously the upper extremity PNF patterns.	Behavioural	Supervised EMG Biofeedback Exercise Training Group
Home-Based Exercise Training GroupPosture training and ergonomic arrangements in the workplace. Posture correction exercises, contains strengthening, stretching, mobility and relaxation exercises, will be given as a home exercises program. Exercise diary and weekly calls will be use to maintain the exercise adherence	Behavioural	Home-Based Exercise Training Group
Posture Training/Ergonomic Regulations GroupPosture training and ergonomic arrangements in the workplace.	Behavioural	Posture Training/Ergonomic Regulations Group

Primary outcome

Maximal Voluntary Isometric Contraction (MVIC)
Time frame: 10 minutes
It is assessed by Surface Electromyography (sEMG) for upper trapezius muscle. 3 maximum contractions are performed for 6 seconds at the manual muscle testing position. The maximum value among 3 repeats is recorded as Maximal Voluntary Isometric Contraction (MVIC) (mV).
Muscle Activation of Upper Trapezius
Time frame: 30 minutes
It is the measurement of the Electromyographic activity of trapezius muscles during functional tasks and rest. According to The Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles Project (SENIAM) recommendations for sensors and sensor placement procedures, sEMG will be applied for the upper trapezius muscles while resting and also performing the computer task in workplace. The mean values (mV) obtained are normalized according to MVIC. Normalized data (%MVIC) are used in the statistical analysis.
Cervical Range of Motion (CROM) / Forward Head Posture
Time frame: 10 minutes
The CROM Deluxe is an assessment instrument that lets to measure sagittal, frontal and horizontal plane movements (flexion / extension, lateral flexion, rotation and forward head posture), while resting and also performing a task or work posture.

6 secondary outcomes

Constant-Murley Score (CMS)
Time frame: 10 minutes
Rapid Upper Limb Assessment (RULA)
Time frame: 10 minutes
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time frame: 10 minutes
The Disabilities of the Arm, Shoulder and Hand Score Work Module (DASH-W)
Time frame: 2 minutes
Neck Disability Index (NDI)
Time frame: 10 minutes
Neck Pain and Disability Scale (NPAD)
Time frame: 10 minutes

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 14 Apr 2022.
Individual participant dataSharing planned: No

Related trials for Work-related Musculoskeletal Disorders

Recruiting
Exercise and Health Education for Musculoskeletal Health in Industrial Workers
Work-Related Musculoskeletal Disorders
Not yet recruiting
Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback
Work-Related Musculoskeletal Disorders
Not yet recruitingObservational study
National Survey of Chronic Occupational Pain in Thai Anesthesia Providers
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET®
Musculoskeletal Diseases or Conditions
Not yet recruitingObservational study
A Digital Ergonomics Assessment of Work-related Musculoskeletal Disorders Risk Between Female and Male Physical Therapists.
Musculoskeletal Disorder

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.

Nilufer Keskin Dilbay, PT, MSc principal investigator

Marmara University

Zafer Erden, PT PhD Prof. study director

Hacettepe University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 1 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 14 Apr 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

Maximal Voluntary Isometric Contraction (MVIC) (time frame: 10 minutes). The study lists 3 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 NCT04198675.

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 14 Apr 2022.