NCT06280937

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 15, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

spinepain threshold

Outcome Measures

Primary Outcomes (3)

  • The Change in the Viscoelastic Properties of the Muscles

    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

    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

    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 Outcomes (5)

  • Activity Limitation

    Change from baseline activity limitation at eight hours

  • Global Rating of Change

    Change from baseline global rating of change at eight hours

  • Trunk Forward Bending Mobility

    Change from baseline cervical range of motion at immediate, eight hours and one day

  • Trunk Lateral Bending Mobility

    Change from baseline cervical range of motion at immediate, eight hours and one day

  • Neck Circumference

    At baseline

Study Arms (2)

Control Group

NO INTERVENTION

In this group, participants will go on their daily activities. No additional intervention will be applied to the participants in this group.

Study Group

EXPERIMENTAL

In this group, participants will wear a tie during one office working day

Other: Wearing a tie

Interventions

Individuals in the study group will be asked to wear a tie during one office working day.

Study Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants' gender must be stated as male in their identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, Merkez, 13000, Turkey (Türkiye)

Location

Related Publications (10)

  • Yoo IG, Kim MH, Yoo WG. Effects of wearing a tight necktie on cervical range of motion and upper trapezius muscle activity during computer work. Work. 2011;39(3):261-6. doi: 10.3233/WOR-2011-1174.

    PMID: 21709362BACKGROUND
  • Usgu S, Ramazanoglu E, Yakut Y. The Relation of Body Mass Index to Muscular Viscoelastic Properties in Normal and Overweight Individuals. Medicina (Kaunas). 2021 Sep 26;57(10):1022. doi: 10.3390/medicina57101022.

    PMID: 34684059BACKGROUND
  • Ramazanoglu E, Turhan B, Usgu S. Evaluation of the tone and viscoelastic properties of the masseter muscle in the supine position, and its relation to age and gender. Dent Med Probl. 2021 Apr-Jun;58(2):155-161. doi: 10.17219/dmp/132241.

    PMID: 34076970BACKGROUND
  • Wu Z, Zhu Y, Xu W, Liang J, Guan Y, Xu X. Analysis of Biomechanical Properties of the Lumbar Extensor Myofascia in Elderly Patients with Chronic Low Back Pain and That in Healthy People. Biomed Res Int. 2020 Feb 18;2020:7649157. doi: 10.1155/2020/7649157. eCollection 2020.

    PMID: 32149135BACKGROUND
  • Tawde P, Dabadghav R, Bedekar N, Shyam A, Sancheti P. Assessment of cervical range of motion, cervical core strength and scapular dyskinesia in violin players. Int J Occup Saf Ergon. 2016 Dec;22(4):572-576. doi: 10.1080/10803548.2016.1181892. Epub 2016 May 27.

    PMID: 27232160BACKGROUND
  • Youdas JW, Carey JR, Garrett TR. Reliability of measurements of cervical spine range of motion--comparison of three methods. Phys Ther. 1991 Feb;71(2):98-104; discussion 105-6. doi: 10.1093/ptj/71.2.98.

    PMID: 1989013BACKGROUND
  • Ylinen J, Takala EP, Kautiainen H, Nykanen M, Hakkinen A, Pohjolainen T, Karppi SL, Airaksinen O. Effect of long-term neck muscle training on pressure pain threshold: a randomized controlled trial. Eur J Pain. 2005 Dec;9(6):673-81. doi: 10.1016/j.ejpain.2005.01.001.

    PMID: 16246820BACKGROUND
  • Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.

    PMID: 17996549BACKGROUND
  • Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of dry needling on mechanical and contractile properties of the upper trapezius with latent myofascial trigger points: A randomized controlled trial. Musculoskelet Sci Pract. 2021 Dec;56:102456. doi: 10.1016/j.msksp.2021.102456. Epub 2021 Sep 3.

    PMID: 34507046BACKGROUND
  • Liu CL, Feng YN, Zhang HQ, Li YP, Zhu Y, Zhang ZJ. Assessing the viscoelastic properties of upper trapezius muscle: Intra- and inter-tester reliability and the effect of shoulder elevation. J Electromyogr Kinesiol. 2018 Dec;43:226-229. doi: 10.1016/j.jelekin.2017.09.007. Epub 2017 Oct 19.

    PMID: 29103836BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Dursun, Asst. Prof.

CONTACT

Erhan Dincer, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interventions and assessment will be performed by separate researchers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Control group will go on their routine daily activities. Study group will wear a tie during one office working day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 28, 2024

Study Start

March 1, 2024

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations