- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06864650
Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain
August 28, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain: a Randomized Controlled Trial
This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was planned as a randomized controlled study.
Workers between the ages of 18-60 who have back pain and work in an automotive factory in Galway, Ireland will be included in the study.
Participants will be divided into two groups.
The factory workers included in the study will be divided into a study group and a control group using a simple random method.
Randomization will be done using the sealed envelope method.
The study group will be given stretching and strengthening exercises along with ergonomics training.
The control group will be given only ergonomics training.
The exercises they will do and the ergonomics training will be explained to the participants individually and supported with a brochure.
The participants will be asked to do the given exercises 3 days a week and continue for 12 weeks.
The given exercises will be followed up with an exercise follow-up chart.
In order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill it out.
In order to collect data from the participants; Visual Analog Scale will be used to collect information about pain, International Physical Activity Questionnaire to collect information about physical activity levels, Pittsburgh Sleep Quality Questionnaire to determine sleep quality, Oswestry Low Back Pain Scale for functionality assessment, Manual Muscle Testing to determine muscle strength.
These questionnaires will be repeated before starting the study and at the end of the study.
The data to be obtained will be evaluated using SPSS 24 package program.
Study Type
Interventional
Enrollment (Actual)
56
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
-
-
-
Galway, Ireland
- Valeo Vision System
-
-
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
- Having worked in the same factory for at least 2 years
- Working full time
- Having complained of back pain for at least 3 months
- visual analog scale>4, pain 4 and above on visual analog scale
Exclusion Criteria
- Being under 18 years old or over 60 years old
- Having worked for less than 2 years
- Working part time
- Having complained of back pain for less than 3 months
- visual analog scale Presence of psychological problems
- Using sleeping pills
- Having undergone surgical intervention in the last 6 months
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: Ergonomics training
group without any intervention
|
Each of the control group participants will receive separate ergonomics training.
The content of this training will include the topics of "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk factors."
|
|
Experimental: Ergonomics training +exercise program
The group that followed the 12-week exercise program
|
Each of the control group participants will receive separate ergonomics training.
The content of this training will include the topics of "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk factors."
stretching exercises strengthening exercises waist exercises core exercises relaxation exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 14 weeks
|
It was developed to measure the functionality of individuals.
The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep.
There are 10 questions in this scale.
Each question has 6 options.
Participants are asked to choose the definition that best describes their situation from these options.
A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points.
It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.
|
14 weeks
|
|
The Pittsburgh Sleep Quality Index
Time Frame: 14 weeks
|
Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions.
19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse.
There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points.
The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality
|
14 weeks
|
|
Short form of the International Physical Activity Questionnaire
Time Frame: 14 weeks
|
It consists of 8 questions with a recall period defined as 'last week'.
The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities.
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kübra TOSYALI, 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
- Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.
- Pehlevan E, Sevgin O. Effect of exercise given to factory workers with ergonomics training on pain and functionality: A randomized controlled trial. Work. 2024;78(1):195-205. doi: 10.3233/WOR-230663.
- Stieglitz DD, Vinson DR, Hampton MC. Equipment-based Pilates reduces work-related chronic low back pain and disability: A pilot study. J Bodyw Mov Ther. 2016 Jan;20(1):74-82. doi: 10.1016/j.jbmt.2015.06.006. Epub 2015 Jun 15.
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)
March 25, 2025
Primary Completion (Actual)
June 25, 2025
Study Completion (Actual)
August 10, 2025
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 7, 2025
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 28, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Technology, Industry, and Agriculture
- Physical Conditioning, Human
- Exercise
- Engineering
- Resistance Training
- Ergonomics
Other Study ID Numbers
- Uskudar25
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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