Short Term Effect of Wearing a Tie

February 20, 2024 updated by: Omer Dursun, Bitlis Eren University

Short Term Effect of Wearing a Tie on Musculoskeletal System

The goal of this randomized controlled study is to assess the short term effect of wearing a ties on musculoskeletal system. In this scope viscoelastic properties and the mechanosensitivity of the muscles, and cervical range of motion will be measured. In addition to these measurements activity limitation due to wearing a tie and trunk mobility will be assessed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of at least 54 volunteers who satisfies the eligibility criteria of the study will be recruited to the study. Following to the recruitment process participants will be randomly assigned to the one of the two groups. Participants in the control group will go on to their daily activities. Participants in the study group will be asked to wear a tie for one working day.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Merkez
      • Bitlis, Merkez, Turkey, 13000
        • Bitlis Eren University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age of 18 to 25 years
  • Given a signed consent
  • Low level of physical activity
  • Having a BMI between 18 kg/m2 and 25 kg/m2
  • No pain in neck, upper and lower back (numerical pain rating scale below 3 points)

Exclusion Criteria:

  • Having a systemic or metabolic disease
  • Having a mental disorder
  • Chronic drug use
  • Any condition that may result in muscle atrophy
  • Musculoskeletal surgery history in last 3 months
  • Having a cervical, thoracal or lumbar radiculopathy or myelopathy
  • Having a whiplash syndrome or fibromyalgia
  • Having performed any strenuous exercises within the 24 h prior to measurements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
In this group, participants will go on their daily activities. No additional intervention will be applied to the participants in this group.
Experimental: Study Group
In this group, participants will wear a tie during one office working day
Other: Wearing a tie
Individuals in the study group will be asked to wear a tie during one office working day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in the Viscoelastic Properties of the Muscles
Time Frame: Change from baseline pain at eight hours and one day
The effect of wearing a tie on the viscoelastic properties of participants' upper trapezius, cervical, thoracic, and lumbar paravertebral muscles will be measured using the myotonometer (MyotonPRO). Tonus measurement of the trapezius muscle will be taken from the upper, middle and lower part of the muscle. Evaluation of cervical muscle tone will be conducted 2 cm to the right and left of the C4 spinous process. The measurement will be taken on the semispinalis capitis muscle while the individual lies face down on the treatment bed. Muscle tone measurements for the thoracic and lumbar regions will be taken on the paravertebral muscles at the T3, T7, T11, L1 and L4 levels.
Change from baseline pain at eight hours and one day
The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius
Time Frame: Change from baseline mechanosensitivity at eight hours and one day
The potential impact of wearing a tie on individuals' pain thresholds will be evaluated using an analog algometer. Pain threshold measurements will be taken at the upper trapezius muscle, C6, T6, and L4 vertebral spinous processes. The algometer will be positioned perpendicular to the measurement areas. Three measurements will be taken for each region, with a half-minute interval between measurements. The average of the three measurements will be calculated and recorded. A change of 20-25% in the algometric measurement values will be considered significant.
Change from baseline mechanosensitivity at eight hours and one day
Cervical Range of Motion
Time Frame: Change from baseline cervical range of motion at immediate, eight hours and one day
The effect of wearing a tie on participants' cervical range of motion will be measured using a 10-inch standard manual goniometer. For measuring cervical flexion and extension range of motion, the pivot point of the goniometer will be placed at the external auditory meatus. The fixed arm of the goniometer will be held vertically, and the moving arm will follow along the base of the nostrils. To measure cervical rotation range of motion, measurements will be taken from behind the participants. The pivot point of the goniometer will be placed at the vertex, while the fixed arm will be kept parallel to the acromion and the moving arm will follow along with their nose. Lateral flexion range of motion will be taken in front of the participants. The pivot point of the goniometer will be placed over the sternal notch, with its fixed arm parallel to the acromion and its moving arm will follow along tip of the participants' nose. Each range of motion measurement will be performed three times.
Change from baseline cervical range of motion at immediate, eight hours and one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Limitation
Time Frame: Change from baseline activity limitation at eight hours
The activities that individuals find difficult due to wearing a tie will be assessed using a visual analog scale. Individuals will be asked to rate three activities they find difficult while wearing a tie on a scale from 0 to 10. A score of 0 indicates no difficulty, while a score of 10 indicates that performing the activity is nearly impossible.
Change from baseline activity limitation at eight hours
Global Rating of Change
Time Frame: Change from baseline global rating of change at eight hours
In the study group, the Global Rating of Change Scale (GROC) will be used to assess the changes experienced by individuals after wearing a tie. The scale ranges from "-7" to "+7" and consists of a total of 15 points. A score of "-7" indicates a much worse condition, while a score of "+7" indicates a much better condition.
Change from baseline global rating of change at eight hours
Trunk Forward Bending Mobility
Time Frame: Change from baseline cervical range of motion at immediate, eight hours and one day
The potential effect of wearing a tie on trunk flexion mobility will be assessed using the fingertip-to-floor test. In the fingertip-to-floor test, individuals will be asked to stand barefoot and adjacent to a platform of 20 cm in height without bending their knees, toes, or arms, and to lean forward towards their toes. Then, the distance from the ground will be measured using a measuring tape. The measurement will be repeated twice, and the average of the measurements will be taken.
Change from baseline cervical range of motion at immediate, eight hours and one day
Trunk Lateral Bending Mobility
Time Frame: Change from baseline cervical range of motion at immediate, eight hours and one day
The potential effect of wearing a tie on trunk lateral bending mobility will be assessed using the fingertip-to-floor test. In the fingertip-to-floor test, individuals will be asked to stand barefoot and adjacent to a platform of 20 cm in height without bending their knees, toes, or arms, and to bend laterally towards their toes. Then, the distance from the ground to the tip of the middle finger will be measured using a measuring tape. The measurement will be repeated twice, and the average of the measurements will be taken.
Change from baseline cervical range of motion at immediate, eight hours and one day
Neck Circumference
Time Frame: At baseline
While the participant looking straight ahead, with relaxed shoulders (not hunched), middle and lower neck circumference will be measured with the measuring tape.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: Ömer Dursun, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Erhan Dincer, M.Sc., Bitlis Eren University
  • Principal Investigator: Cihan Önen, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Deniz Akbulut, M.D., Van Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Disorder

Clinical Trials on Wearing a tie

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe