Neck PainNCT06689722
Effectiveness of Chiropractic Treatment Applied Together With Ergonomics Education in Factory Workers With Neck Pain
A study testing chiropractic and ergonomics in people with Neck Pain and Work-related Illness, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of chiropractic treatment combined with ergonomic training in factory workers with nonspecific neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Work-related Illness
- What is being tested?
- chiropractic and ergonomics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 2 Jan 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 18-65 years of age,
- Having neck pain for the last 3 months,
- Neck pain being 4 or higher on the Visual Analog Scale
Who cannot join
- Having undergone surgery in the last 6 months,
- Not being cooperative,
- Presence of psychological problems,
- Neck pain being of radicular or neurological origin,
- Presence of a systemic or metabolic disease such as cancer, Instability in the neck,
- Vertebro-basilar insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Chiropractic Treatment Applied Together With Ergonomics Education in Factory Workers With Nonspecific Neck Pain: A Randomized Study
The aim of this study is to investigate the effectiveness of chiropractic treatment combined with ergonomic training in factory workers with nonspecific neck pain.
Read the detailed description
The study was planned as a randomized controlled study. Workers between the ages of 18-60 who are working in a heat treatment factory in izmir and experiencing non-specific neck pain will be included in the study. The factory workers included in the study will be divided into three by simple random method. The groups will be called chiropractic, placebo and control groups. All participants will be given ergonomic training before the treatment. The chiropractic group will be applied 2 days a week. The placebo group will also be applied sham manipulation 2 days a week. No intervention will be made in the control group. In order to collect data from the participants; Visual Analog Scale, Neck Disability Questionnaire and Bournemouth will be used for pain and pain-related dysfunctions, and Pittsburgh Sleep Quality Questionnaire will be used to determine sleep quality. These questionnaires will be repeated before starting the study and at the end of the study.
- Conditions
- Neck Pain, Work-related Illness
- Being tested
- chiropractic, sham, ergonomics
- Keywords
- chiropractic, occupational diseases
- Medical subject headings
- Neck Pain, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropracticOther
Chiropractic practice was applied using the diversified technique, which is one of the types of chiropractic techniques.
shamOther
The patient was asked if he/she had any pain or other complaints during the trial mobilization. High-velocity, low-amplitude impulses were applied to the inferior and lateral directions for patients who did not describe any complaints.
ergonomicsOther
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
| Study group | Role | What they receive |
|---|---|---|
| chiropractic | Experimental | chiropractic practices Receives: Other: chiropractic; Other: ergonomics |
| placebo | Sham comparator | sham manipulation applications Receives: Other: sham; Other: ergonomics |
| control | Active comparator | those who did not receive any intervention Receives: Other: ergonomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 5 weeks
Neck Pain Disability Index Questionnaire
The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
Measured: 5 weeks
Bournemouth Neck Pain Survey
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start15 Nov 2024
- Primary completion25 Dec 2024
- Study completion2 Jan 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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 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
- Deniz Balıkçı, Study chair, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689722
- Sponsor's protocol ID
- Uskudar14
- Status last verified
- Jan 2025
- First submitted
- 12 Nov 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38701125Zengi H, Safran EE, Sevgin O. The effect of home exercises with kinesiotaping on pain, functionality, and work performance in bus drivers with non-specific neck pain. J Back Musculoskelet Rehabil. 2024;37(6):1617-1630. doi: 10.3233/BMR-240001.
PubMed 38943382Chaibi A, Allen-Unhammer A, Kopke Vollestad N, Russell MB. Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol. PLoS One. 2023 Dec 7;18(12):e0295115. doi: 10.1371/journal.pone.0295115. eCollection 2023.
PubMed 38060549
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Chiropractic Treatment Applied Together With Ergonomics Education in Factory Workers With Nonspecific Neck Pain: A Randomized Study
- ClinicalTrials.gov ID
- NCT06689722
- Acronym / sponsor ID
- Uskudar14
- Conditions
- Neck Pain, Work-related Illness
- Keywords
- chiropractic, occupational diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 14 Nov 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 this study is to investigate the effectiveness of chiropractic treatment combined with ergonomic training in factory workers with nonspecific neck pain.
Detailed description
The study was planned as a randomized controlled study. Workers between the ages of 18-60 who are working in a heat treatment factory in izmir and experiencing non-specific neck pain will be included in the study. The factory workers included in the study will be divided into three by simple random method. The groups will be called chiropractic, placebo and control groups. All participants will be given ergonomic training before the treatment. The chiropractic group will be applied 2 days a week. The placebo group will also be applied sham manipulation 2 days a week. No intervention will be made in the control group. In order to collect data from the participants; Visual Analog Scale, Neck Disability Questionnaire and Bournemouth will be used for pain and pain-related dysfunctions, and Pittsburgh Sleep Quality Questionnaire will be used to determine sleep quality. These questionnaires will be repeated before starting the study and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chiropractic | Experimental | Other: chiropractic, Other: ergonomicschiropractic practices |
| placebo | Sham comparator | Other: sham, Other: ergonomicssham manipulation applications |
| control | Active comparator | Other: ergonomicsthose who did not receive any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between 18-65 years of age,
- Having neck pain for the last 3 months,
- Neck pain being 4 or higher on the Visual Analog Scale
Key exclusion criteria (6 listed)
- Having undergone surgery in the last 6 months,
- Not being cooperative,
- Presence of psychological problems,
- Neck pain being of radicular or neurological origin,
- Presence of a systemic or metabolic disease such as cancer, Instability in the neck,
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 |
|---|---|---|
| chiropracticChiropractic practice was applied using the diversified technique, which is one of the types of chiropractic techniques. | Other | chiropractic |
| shamThe patient was asked if he/she had any pain or other complaints during the trial mobilization. High-velocity, low-amplitude impulses were applied to the inferior and lateral directions for patients who did not describe any complaints. | Other | placebo |
| ergonomicsErgonomics 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 | chiropractic, control, placebo |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 5 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".
Neck Pain Disability Index Questionnaire
Time frame: 5 weeks
The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
Bournemouth Neck Pain Survey
Time frame: 5 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.
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 6 Jan 2025.
- 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.
- Background: PubMed 38943382Zengi H, Safran EE, Sevgin O. The effect of home exercises with kinesiotaping on pain, functionality, and work performance in bus drivers with non-specific neck pain. J Back Musculoskelet Rehabil. 2024;37(6):1617-1630. doi: 10.3233/BMR-240001.
- Background: PubMed 38060549Chaibi A, Allen-Unhammer A, Kopke Vollestad N, Russell MB. Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol. PLoS One. 2023 Dec 7;18(12):e0295115. doi: 10.1371/journal.pone.0295115. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Deniz Balıkçı study chair
Bahçeşehir 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 chiropractic and ergonomics in people with Neck Pain and Work-related Illness, 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 3 inclusion and 6 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 6 Jan 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 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. Some participants in this study may receive a placebo. 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 Pittsburgh Sleep Quality Index (PSQI) (time frame: 5 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 NCT06689722, 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 6 Jan 2025.