Work-related IllnessNCT06004284
Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
A study testing exercise group in people with Work-related Illness and Work Accident, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of ergonomics training with exercises applied on factory workers with low back pain on pain, functionality, sleep and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-related Illness, Work Accident, Occupational Diseases
- What is being tested?
- exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 18 Oct 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be between the ages of 18-65,
- Having low back pain in the last 3 months
- Visual Pain Scale (VAS) >4
- No surgical intervention in the last 6 months,
Who cannot join
- Not being cooperative desk work
- Presence of psychological problems,
- Using sleeping pills
- Presence of neurological and orthopedic disease.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effects of ergonomics training with exercises applied on factory workers with low back pain on pain, functionality, sleep and fatigue.
Read the detailed description
The study was planned as a randomized controlled trial. Workers between the ages of 18 and 60 working in a plastic casting factory in Gebze/Kocaeli with back and low back pain will be included in the study. Participants will be divided into two groups using a simple randomization method. Ergonomics training will be given to the first group together with core stabilization exercises; The second group will be given only ergonomics training. The exercises they will do will be explained to the participants individually and will be supported by an exercise brochure. Participants will be asked to do the given exercises 3 days a week and continue for 8 weeks. Follow-up of the given exercises will be done with the exercise follow-up chart. Persons with psychological or physical disabilities who can exercise regularly will not be included in the study. 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 in this form. In order to collect data from the participants; "McGill Pain Questionnaire (Short)" and "Visual Analog Scale" to collect information on pain; "Fatigue Severity Scale" will be used to determine fatigue levels, "Pittsburgh Sleep Quality Questionnaire" will be used to determine sleep quality, and "Oswestry Low Back Pain Scale" will be used to evaluate functionality. The questionnaires will be repeated before and after the study. The data before and after the intervention will be analyzed statistically.
- Conditions
- Work-related Illness, Work Accident, Occupational Diseases
- Being tested
- control, exercise group
- Keywords
- Workers, pain, exercise, ergonomics, Functionality
- Medical subject headings
- Occupational Diseases, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
Ergonomics training will be given to each of the control group participants individually. The content of this training will include "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa
exercise groupOther
The exercise training program will be applied for 8 weeks, 3 days a week and for an average of 20-30 minutes. After the maneuver is taught, stretching exercises lasting 5 minutes for warm-up purposes and posture and core exercises lasting 25 minutes will be taught. Among the stretching exercises, quadratus lumborum stretching, hamstring stretching, erector spina stretching, hip extensor stretching exercises will be applied. Posterior pelvic tilt exercise will be performed as a control and smoothing exercise for the vertebrae of the lumbar and pelvic region. Among the core stabilization exercises, bridging, plank, plank in side lying, abdominal strengthening, cross arm leg lifting exercises in crawling position will be performed. Each exercise position will be required to be maintained for 8 seconds and to do 10-15 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Only ergonomics training will be given to the control group. Receives: Other: control |
| exercise group | Experimental | Participants will be given training including stretching and core exercises along with ergonomics training. Receives: Other: exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The McGill Pain Questionnaire (MPQ)
McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the VAS, and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).
Measured: 10 weeks
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: 10 weeks
Fatigue Severity Scale (FSS)
This scale consists of 9 questions and each option has a score between 0-7. A score of 0 is expressed as "strongly disagree", while a score of 7 is expressed as "agree". The maximum score is 7, and it is recorded that people have a significant degree of fatigue for 4 points and above.
Measured: 10 weeks
The Pittsburgh Sleep Quality Index (PSQI)
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: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Model description
- Participants will be given exercise practices along with ergonomics training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 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
- Elif PEHLEVAN, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004284
- Sponsor's protocol ID
- Uskudar69
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erick PN, Smith DR. A systematic review of musculoskeletal disorders among school teachers. BMC Musculoskelet Disord. 2011 Nov 17;12:260. doi: 10.1186/1471-2474-12-260.
PubMed 22087739Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009 Mar;19(1):8-24. doi: 10.1007/s10926-009-9164-5. Epub 2009 Feb 14.
PubMed 19219537Biman S, Maharana S, Metri KG, Nagaratna R. Effects of yoga on stress, fatigue, musculoskeletal pain, and the quality of life among employees of diamond industry: A new approach in employee wellness. Work. 2021;70(2):521-529. doi: 10.3233/WOR-213589.
PubMed 34633352Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.
PubMed 27849389Abdollahi T, Pedram Razi S, Pahlevan D, Yekaninejad MS, Amaniyan S, Leibold Sieloff C, Vaismoradi M. Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2020 Oct 8;17(19):7333. doi: 10.3390/ijerph17197333.
PubMed 33049927Jaromi M, Nemeth A, Kranicz J, Laczko T, Betlehem J. Treatment and ergonomics training of work-related lower back pain and body posture problems for nurses. J Clin Nurs. 2012 Jun;21(11-12):1776-84. doi: 10.1111/j.1365-2702.2012.04089.x.
PubMed 22594388
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
- ClinicalTrials.gov ID
- NCT06004284
- Acronym / sponsor ID
- Uskudar69
- Conditions
- Work-related Illness, Work Accident, Occupational Diseases
- Keywords
- Workers, pain, exercise, ergonomics, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 22 Aug 2023 (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.
The aim of this study is to evaluate the effects of ergonomics training with exercises applied on factory workers with low back pain on pain, functionality, sleep and fatigue.
Detailed description
The study was planned as a randomized controlled trial. Workers between the ages of 18 and 60 working in a plastic casting factory in Gebze/Kocaeli with back and low back pain will be included in the study. Participants will be divided into two groups using a simple randomization method. Ergonomics training will be given to the first group together with core stabilization exercises; The second group will be given only ergonomics training. The exercises they will do will be explained to the participants individually and will be supported by an exercise brochure. Participants will be asked to do the given exercises 3 days a week and continue for 8 weeks. Follow-up of the given exercises will be done with the exercise follow-up chart. Persons with psychological or physical disabilities who can exercise regularly will not be included in the study. 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 in this form. In order to collect data from the participants; "McGill Pain Questionnaire (Short)" and "Visual Analog Scale" to collect information on pain; "Fatigue Severity Scale" will be used to determine fatigue levels, "Pittsburgh Sleep Quality Questionnaire" will be used to determine sleep quality, and "Oswestry Low Back Pain Scale" will be used to evaluate functionality. The questionnaires will be repeated before and after the study. The data before and after the intervention will be analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be given exercise practices along with ergonomics training.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: controlOnly ergonomics training will be given to the control group. |
| exercise group | Experimental | Other: exercise groupParticipants will be given training including stretching and core exercises along with ergonomics training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be between the ages of 18-65,
- Having low back pain in the last 3 months
- Visual Pain Scale (VAS) >4
- No surgical intervention in the last 6 months,
Key exclusion criteria (4 listed)
- Not being cooperative desk work
- Presence of psychological problems,
- Using sleeping pills
- Presence of neurological and orthopedic disease.
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 |
|---|---|---|
| controlErgonomics training will be given to each of the control group participants individually. The content of this training will include "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa | Other | control group |
| exercise groupThe exercise training program will be applied for 8 weeks, 3 days a week and for an average of 20-30 minutes. After the maneuver is taught, stretching exercises lasting 5 minutes for warm-up purposes and posture and core exercises lasting 25 minutes will be taught. Among the stretching exercises, quadratus lumborum stretching, hamstring stretching, erector spina stretching, hip extensor stretching exercises will be applied. Posterior pelvic tilt exercise will be performed as a control and smoothing exercise for the vertebrae of the lumbar and pelvic region. Among the core stabilization exercises, bridging, plank, plank in side lying, abdominal strengthening, cross arm leg lifting exercises in crawling position will be performed. Each exercise position will be required to be maintained for 8 seconds and to do 10-15 repetitions. | Other | exercise group |
Primary outcome
The McGill Pain Questionnaire (MPQ)
Time frame: 10 weeks
McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the VAS, and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).
Oswestry Low Back Pain Disability Questionnaire
Time frame: 10 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.
Fatigue Severity Scale (FSS)
Time frame: 10 weeks
This scale consists of 9 questions and each option has a score between 0-7. A score of 0 is expressed as "strongly disagree", while a score of 7 is expressed as "agree". The maximum score is 7, and it is recorded that people have a significant degree of fatigue for 4 points and above.
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 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".
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 19 Oct 2023.
- Background: PubMed 22087739Erick PN, Smith DR. A systematic review of musculoskeletal disorders among school teachers. BMC Musculoskelet Disord. 2011 Nov 17;12:260. doi: 10.1186/1471-2474-12-260.
- Background: PubMed 19219537Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009 Mar;19(1):8-24. doi: 10.1007/s10926-009-9164-5. Epub 2009 Feb 14.
- Background: PubMed 34633352Biman S, Maharana S, Metri KG, Nagaratna R. Effects of yoga on stress, fatigue, musculoskeletal pain, and the quality of life among employees of diamond industry: A new approach in employee wellness. Work. 2021;70(2):521-529. doi: 10.3233/WOR-213589.
- Background: PubMed 27849389Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.
- Background: PubMed 33049927Abdollahi T, Pedram Razi S, Pahlevan D, Yekaninejad MS, Amaniyan S, Leibold Sieloff C, Vaismoradi M. Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2020 Oct 8;17(19):7333. doi: 10.3390/ijerph17197333.
- Background: PubMed 22594388Jaromi M, Nemeth A, Kranicz J, Laczko T, Betlehem J. Treatment and ergonomics training of work-related lower back pain and body posture problems for nurses. J Clin Nurs. 2012 Jun;21(11-12):1776-84. doi: 10.1111/j.1365-2702.2012.04089.x.
- 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.
Elif PEHLEVAN 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 exercise group in people with Work-related Illness and Work Accident, run by Uskudar University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 19 Oct 2023. 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 Turkey (Türkiye). 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?
The McGill Pain Questionnaire (MPQ) (time frame: 10 weeks). The study lists 4 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 NCT06004284, which also lists 6 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 19 Oct 2023.