Work-related IllnessNCT06864650
Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain
A study testing Ergonomics training and exercise program in people with Work-related Illness, run by Uskudar University at 1 site in Ireland.
Trial summary
This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-related Illness
- What is being tested?
- Ergonomics training and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIreland
- Study dates
- 25 Mar 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Work-related Illness
- Being tested
- Ergonomics training, exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomics trainingOther
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."
exercise programOther
stretching exercises strengthening exercises waist exercises core exercises relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Ergonomics training | Active comparator | group without any intervention Receives: Other: Ergonomics training |
| Ergonomics training +exercise program | Experimental | The group that followed the 12-week exercise program Receives: Other: Ergonomics training; Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
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.
Measured: 14 weeks
The Pittsburgh Sleep Quality Index
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
Measured: 14 weeks
Short form of the International Physical Activity Questionnaire
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start25 Mar 2025
- Primary completion25 Jun 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Work-related IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Kübra TOSYALI, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864650
- Sponsor's protocol ID
- Uskudar25
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26891640Chenot 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.
PubMed 29321099Pehlevan 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.
PubMed 38701125
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06864650
- Acronym / sponsor ID
- Uskudar25
- Conditions
- Work-related Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergonomics training | Active comparator | Other: Ergonomics traininggroup without any intervention |
| Ergonomics training +exercise program | Experimental | Other: Ergonomics training, Other: exercise programThe group that followed the 12-week exercise program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomics trainingEach 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." | Other | Ergonomics training, Ergonomics training +exercise program |
| exercise programstretching exercises strengthening exercises waist exercises core exercises relaxation exercises | Other | Ergonomics training +exercise program |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 26891640Stieglitz 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.
- Background: PubMed 29321099Chenot 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.
- Background: PubMed 38701125Pehlevan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kübra TOSYALI study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomics training and exercise program in people with Work-related Illness, run by Uskudar University at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low Back Pain Disability Questionnaire (time frame: 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06864650, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.