NCT04198675

Brief 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. In addition, aimed to reduce the loss of work with measures to improve the quality and efficiency of work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

September 1, 2019

Last Update Submit

April 6, 2022

Conditions

Work-related Musculoskeletal DisordersOffice Workers

Keywords

Surface ElectromyographyBiofeedbackForward Head PosturePostureTrapezius MuscleTask- specific PerformanceExerciseOffice Worker

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    10 minutes

Secondary Outcomes (6)

  • Constant-Murley Score (CMS)

    10 minutes

  • Rapid Upper Limb Assessment (RULA)

    10 minutes

  • The Disabilities of the Arm, Shoulder and Hand Score (DASH)

    10 minutes

  • The Disabilities of the Arm, Shoulder and Hand Score Work Module (DASH-W)

    2 minutes

  • Neck Disability Index (NDI)

    10 minutes

  • +1 more secondary outcomes

Study Arms (3)

Supervised EMG Biofeedback Exercise Training Group

ACTIVE COMPARATOR

Frequency: 3/week Duration:6 weeks Dosage: Tolerable intensity-dependent increase in exercises program.

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.

Behavioral: Home-Based Exercise Training Group

Posture Training/Ergonomic Regulations Group

SHAM COMPARATOR

1 session, no further intervention until second evaluation for 6 weeks.

Behavioral: Posture Training/Ergonomic Regulations Group

Interventions

Supervised EMG Biofeedback Exercise Training GroupBEHAVIORAL

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.

Supervised EMG Biofeedback Exercise Training Group
Home-Based Exercise Training GroupBEHAVIORAL

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

Home-Based Exercise Training Group
Posture Training/Ergonomic Regulations GroupBEHAVIORAL

Posture training and ergonomic arrangements in the workplace.

Posture Training/Ergonomic Regulations Group

Eligibility Criteria

Age22 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Health Sciences

Maltepe, Istanbul, 1464185881, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nilufer Keskin Dilbay, PT, MSc

    Marmara University

    PRINCIPAL INVESTIGATOR

  • Zafer Erden, PT PhD Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc, Research Assistant

Study Record Dates

First Submitted

September 1, 2019

First Posted

December 13, 2019

Study Start

August 26, 2019

Primary Completion

February 15, 2020

Study Completion

September 13, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)