NCT06484569

Brief Summary

The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

June 26, 2024

Last Update Submit

January 3, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Bournemouth Neck Pain Survey

    The survey consists of 7 questions. In addition to questions about pain and disability, it also includes questions about psychosocial issues. Each question is scored between 0 and 10. The highest score is 70, with a higher score indicating a higher level of disability. The content of the survey consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on daily life activities and social life, anxiety-depression level, kinesiophobia and coping with pain.

    14 weeks

  • The Fremantle Neck Awareness Questionnaire

    The questionnaire is a Likert-type questionnaire (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this) that evaluates individual-specific altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body, how they perceive their body position. The total score varies between 0-36. A high score indicates a poor prognosis.

    14 weeks

  • Fatigue Severity Scale

    The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.

    14 weeks

  • Pittsburgh Sleep Quality Survey

    The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.

    14 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

They will receive ergonomics training

Other: Control

exercise

EXPERIMENTAL

Ergonomics training, exercise training and cranio sacral therapy will be applied

Other: ControlOther: exercise and cranio sacral therapy

Interventions

ControlOTHER

The content of ergonomics training will include the definition of ergonomics, ergonomic positions and arrangements. Postural arrangements will be explained to patients individually and supported by a brochure.

controlexercise

Posture exercises Stretching exercises Strengthening Exercises In addition, deep tissue massage will be applied to increase blood circulation and cranio-sacral therapy will be applied to increase cerebrospinal fluid circulation.

exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18-60 years old
  • Working full time
  • Experiencing neck pain

You may not qualify if:

  • Being under 18 or over 60 years old
  • Presence of diseases accompanying neck pain
  • Exercise intolerance
  • Working part time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ölmezler Textile LTD.CO.

Van, Turkey (Türkiye)

Location

Related Publications (6)

  • Islam T. Health Concerns of Textile Workers and Associated Community. Inquiry. 2022 Jan-Dec;59:469580221088626. doi: 10.1177/00469580221088626.

    PMID: 35604168BACKGROUND
  • Michaud F, Pazos R, Lugris U, Cuadrado J. The Use of Wearable Inertial Sensors and Workplace-Based Exercises to Reduce Lateral Epicondylitis in the Workstation of a Textile Logistics Center. Sensors (Basel). 2023 May 27;23(11):5116. doi: 10.3390/s23115116.

    PMID: 37299843BACKGROUND
  • Metgud DC, Khatri S, Mokashi MG, Saha PN. An ergonomic study of women workers in a woolen textile factory for identification of health-related problems. Indian J Occup Environ Med. 2008 Apr;12(1):14-9. doi: 10.4103/0019-5278.40810.

    PMID: 20040992BACKGROUND
  • Eraslan U, Gelecek N, Genc A. Effect of scapular muscle endurance on chronic shoulder pain in textile workers. J Back Musculoskelet Rehabil. 2013;26(1):25-31. doi: 10.3233/BMR-2012-0346.

    PMID: 23411645BACKGROUND
  • Split W, Kotwica S, Woszczak M. [Role of exercise therapy in the prevention of lumbosacral backache in textile industry workers]. Med Pr. 1984;35(6):465-9. Polish.

    PMID: 6242064BACKGROUND
  • Atasoy H, Sevgin O, Karamancioglu B, Dikmen Hosbas B. Ergonomics training with exercise and manual therapy in textile workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Sep;98(7):661-672. doi: 10.1007/s00420-025-02160-9. Epub 2025 Aug 14.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hilal ATASOY

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

July 2, 2024

Primary Completion

November 1, 2024

Study Completion

January 2, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations