Clinical trial NCT06280937: Short Term Effect of Wearing a Tie
Official title: Short Term Effect of Wearing a Tie on Musculoskeletal System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Musculoskeletal Disorder
Keywords: spine
pain threshold
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group will go on their routine daily activities. Study group will wear a tie during one office working day.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Change in the Viscoelastic Properties of the Muscles
timeFrame: Change from baseline pain at eight hours and one day
measure: The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius
timeFrame: Change from baseline mechanosensitivity at eight hours and one day
measure: Cervical Range of Motion
timeFrame: Change from baseline cervical range of motion at immediate, eight hours and one day
Secondary outcomes:
measure: Activity Limitation
timeFrame: Change from baseline activity limitation at eight hours
measure: Global Rating of Change
timeFrame: Change from baseline global rating of change at eight hours
measure: Trunk Forward Bending Mobility
timeFrame: Change from baseline cervical range of motion at immediate, eight hours and one day
measure: Trunk Lateral Bending Mobility
timeFrame: Change from baseline cervical range of motion at immediate, eight hours and one day
measure: Neck Circumference
timeFrame: At baseline
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
state: Merkez
Study officials:
affiliation: Bitlis Eren University
name: Ömer Dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Erhan Dincer, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Cihan Önen, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Van Training and Research Hospital
name: Deniz Akbulut, M.D.
role: PRINCIPAL_INVESTIGATOR
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