Neck PainNCT06407453
Effectiveness of Exercise Given With Ergonomics Training in Tea Workers
A study testing exercise in people with Neck Pain and Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Back Pain, Work-related Illness
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2024to 25 Oct 2024
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 25-45.
- Having been a tea craftsman for at least 10 years.
- Having the ability to read and write Turkish.
- Agreeing to participate in the study voluntarily.
Who cannot join
- Being diagnosed with a serious psychological illness.
- Malignancy
- Advanced osteoporosis
- Being under 25 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers.
Read the detailed description
Individuals who volunteer to participate in the study will be evaluated considering the inclusion and exclusion criteria, and participants will participate in the study after reading and signing the Informed Consent Form. Tea workers who collect tea will be divided into 2 groups. .Demographic Information Form, Visual Analogue Scale (VAS), Upper Extremity Discomfort Analysis, Rapid Upper Extremity Assessment (RULA), Sleep Quality, Scandinavian Musculoskeletal System Questionnaire will be given to the participants of both groups. The surveys will be carried out face to face. After the application of the surveys, statistical data will be obtained. analyzes will be made. One group will be given exercise, the other group will not be given exercise. Post-exercise surveys will be conducted again to check the effectiveness of the exercise.
- Conditions
- Neck Pain, Back Pain, Work-related Illness
- Being tested
- control, exercise
- Medical subject headings
- Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
There will be no interference ergonomics training
exerciseOther
upper extremity strengthening exercises upper extremity stretching exercises ergonomics training posture training relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | No intervention will be made Receives: Other: control |
| exercise | Experimental | exercise program will be applied Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Shoulder and Hand Problems Questionnaire
It is a questionnaire developed by the American Academy of Orthopedic Surgeons (AAOS) based on the World Health Organization (WHO) model and used to evaluate upper extremity function status. The survey consists of three parts, and for all questions in the scale, the person marks the answer that suits him or her on a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all). According to the results of the Arm Shoulder and Hand Problems Questionnaire survey; A result between 0-100 is obtained from each section (0: no problem, 100: maximum problem).
Measured: 14 weeks
Nordic Musculoskeletal Survey
It consists of 11 questions asked as a reference from 9 body regions shown on a visual body diagram of neck, shoulder, back, elbow, hand, wrist, waist, hip, thigh, knee, foot, ankle, and corresponds to 99 data items. The questionnaire primarily questions the presence of pain in 9 body regions. If the person's answer is yes, he moves on to the relevant sub-questions.It is a selection scale rather than a rating.
Measured: 14 weeks
Pittsburgh Sleep Quality Index
The scale is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleeping Medication Use, and Daytime Dysfunction. Each component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. A total score greater than 5 indicates "poor sleep quality".
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 posted9 May 2024
- Study start9 May 2024
- Primary completion15 Oct 2024
- Study completion25 Oct 2024
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 Neck PainStudies 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
- 60 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
- İlayda GÜR, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407453
- Sponsor's protocol ID
- Uskudar6
- Status last verified
- Oct 2024
- First submitted
- 6 May 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhattacharyya N, Chakrabarti D. Ergonomic basket design to reduce cumulative trauma disorders in tea leaf plucking operation. Work. 2012;41 Suppl 1:1234-8. doi: 10.3233/WOR-2012-0308-1234.
PubMed 22316888Mirbod SM, Fujita S, Miyashita K, Inaba R, Iwata H. Some aspects of occupational safety and health in green tea workers. Ind Health. 1995;33(3):101-17. doi: 10.2486/indhealth.33.101.
PubMed 8543474Lallukka T, Hiilamo A, Oakman J, Manty M, Pietilainen O, Rahkonen O, Kouvonen A, Halonen JI. Recurrent pain and work disability: a record linkage study. Int Arch Occup Environ Health. 2020 May;93(4):421-432. doi: 10.1007/s00420-019-01494-5. Epub 2019 Nov 28.
PubMed 31781902Marak TR, Bhagat D, Borah S. Musculoskeletal Disorders of Garo Women Workers Engaged in Tea-Plucking Activity: An Ergonomic Analysis. Indian J Occup Environ Med. 2020 May-Aug;24(2):60-65. doi: 10.4103/ijoem.IJOEM_185_19. Epub 2020 Aug 19.
PubMed 33281373Kairi TK, Dey S. Prevalence of work-related musculoskeletal symptoms among tea garden workers in Bangladesh: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e061305. doi: 10.1136/bmjopen-2022-061305.
PubMed 35534079Gur I, Sevgin O, Dikmen Hosbas B. Effectiveness of ergonomics training and exercise in tea workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Dec;98(9-10):945-955. doi: 10.1007/s00420-025-02185-0. Epub 2025 Nov 18.
PubMed 41251731
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Given With Ergonomics Training in Tea Workers
- ClinicalTrials.gov ID
- NCT06407453
- Acronym / sponsor ID
- Uskudar6
- Conditions
- Neck Pain, Back Pain, Work-related Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 9 May 2024 (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 our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers.
Detailed description
Individuals who volunteer to participate in the study will be evaluated considering the inclusion and exclusion criteria, and participants will participate in the study after reading and signing the Informed Consent Form. Tea workers who collect tea will be divided into 2 groups. .Demographic Information Form, Visual Analogue Scale (VAS), Upper Extremity Discomfort Analysis, Rapid Upper Extremity Assessment (RULA), Sleep Quality, Scandinavian Musculoskeletal System Questionnaire will be given to the participants of both groups. The surveys will be carried out face to face. After the application of the surveys, statistical data will be obtained. analyzes will be made. One group will be given exercise, the other group will not be given exercise. Post-exercise surveys will be conducted again to check the effectiveness of the exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: controlNo intervention will be made |
| exercise | Experimental | Other: exerciseexercise program will be applied |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 25-45.
- Having been a tea craftsman for at least 10 years.
- Having the ability to read and write Turkish.
- Agreeing to participate in the study voluntarily.
Key exclusion criteria (4 listed)
- Being diagnosed with a serious psychological illness.
- Malignancy
- Advanced osteoporosis
- Being under 25 years of age.
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 |
|---|---|---|
| controlThere will be no interference ergonomics training | Other | control |
| exerciseupper extremity strengthening exercises upper extremity stretching exercises ergonomics training posture training relaxation exercises | Other | exercise |
Primary outcome
Arm Shoulder and Hand Problems Questionnaire
Time frame: 14 weeks
It is a questionnaire developed by the American Academy of Orthopedic Surgeons (AAOS) based on the World Health Organization (WHO) model and used to evaluate upper extremity function status. The survey consists of three parts, and for all questions in the scale, the person marks the answer that suits him or her on a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all). According to the results of the Arm Shoulder and Hand Problems Questionnaire survey; A result between 0-100 is obtained from each section (0: no problem, 100: maximum problem).
Nordic Musculoskeletal Survey
Time frame: 14 weeks
It consists of 11 questions asked as a reference from 9 body regions shown on a visual body diagram of neck, shoulder, back, elbow, hand, wrist, waist, hip, thigh, knee, foot, ankle, and corresponds to 99 data items. The questionnaire primarily questions the presence of pain in 9 body regions. If the person's answer is yes, he moves on to the relevant sub-questions.It is a selection scale rather than a rating.
Pittsburgh Sleep Quality Index
Time frame: 14 weeks
The scale is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleeping Medication Use, and Daytime Dysfunction. Each component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. A total score greater than 5 indicates "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 28 Oct 2024.
- Background: PubMed 22316888Bhattacharyya N, Chakrabarti D. Ergonomic basket design to reduce cumulative trauma disorders in tea leaf plucking operation. Work. 2012;41 Suppl 1:1234-8. doi: 10.3233/WOR-2012-0308-1234.
- Background: PubMed 8543474Mirbod SM, Fujita S, Miyashita K, Inaba R, Iwata H. Some aspects of occupational safety and health in green tea workers. Ind Health. 1995;33(3):101-17. doi: 10.2486/indhealth.33.101.
- Background: PubMed 31781902Lallukka T, Hiilamo A, Oakman J, Manty M, Pietilainen O, Rahkonen O, Kouvonen A, Halonen JI. Recurrent pain and work disability: a record linkage study. Int Arch Occup Environ Health. 2020 May;93(4):421-432. doi: 10.1007/s00420-019-01494-5. Epub 2019 Nov 28.
- Background: PubMed 33281373Marak TR, Bhagat D, Borah S. Musculoskeletal Disorders of Garo Women Workers Engaged in Tea-Plucking Activity: An Ergonomic Analysis. Indian J Occup Environ Med. 2020 May-Aug;24(2):60-65. doi: 10.4103/ijoem.IJOEM_185_19. Epub 2020 Aug 19.
- Background: PubMed 35534079Kairi TK, Dey S. Prevalence of work-related musculoskeletal symptoms among tea garden workers in Bangladesh: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e061305. doi: 10.1136/bmjopen-2022-061305.
- Derived from this study: PubMed 41251731Gur I, Sevgin O, Dikmen Hosbas B. Effectiveness of ergonomics training and exercise in tea workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Dec;98(9-10):945-955. doi: 10.1007/s00420-025-02185-0. Epub 2025 Nov 18.
- 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.
İlayda GÜR 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 in people with Neck Pain and Back Pain, 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 28 Oct 2024. 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?
Arm Shoulder and Hand Problems 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 NCT06407453, 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 28 Oct 2024.