- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484569
Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers
January 3, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers: A Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will include workers between the ages of 18-60 who have neck pain and work at Ölmezler Textile Industry Trade limited company in Van province.
Participants will be divided into two groups as experimental and control groups.
All participants will receive ergonomic training.
In addition, exercise training will be given to individuals in the experimental group.
Exercises will be explained individually and will be supported with an exercise brochure.
Craniosacral therapy will also be applied to the experimental group and a brochure will be given to teach joint protection principles.
Participants will be asked to do the given exercises 3 days a week and continue for 12 weeks.
The given exercises will be followed with an exercise follow-up chart.
An evaluation will be made before and after the study.
Study Type
Interventional
Enrollment (Actual)
60
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 Locations
-
-
-
Van, Turkey
- Ölmezler Textile LTD.CO.
-
-
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:
- Being between 18-60 years old
- Working full time
- Experiencing neck pain
Exclusion Criteria:
- Being under 18 or over 60 years old
- Presence of diseases accompanying neck pain
- Exercise intolerance
- Working part time
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control
They will receive ergonomics training
|
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.
|
|
Experimental: exercise
Ergonomics training, exercise training and cranio sacral therapy will be applied
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bournemouth Neck Pain Survey
Time Frame: 14 weeks
|
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
Time Frame: 14 weeks
|
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
Time Frame: 14 weeks
|
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
Time Frame: 14 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hilal ATASOY, Uskudar University
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
- Islam T. Health Concerns of Textile Workers and Associated Community. Inquiry. 2022 Jan-Dec;59:469580221088626. doi: 10.1177/00469580221088626.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
July 2, 2024
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
January 2, 2025
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
June 26, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 3, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Uskudar12
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.
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