- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06689722
Effectiveness of Chiropractic Treatment Applied Together With Ergonomics Education in Factory Workers With Neck Pain
January 3, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
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.
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 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 Type
Interventional
Enrollment (Actual)
45
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
-
-
-
İzmir, Turkey
- Kemalpaşa Heat treatment factory
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: chiropractic
chiropractic practices
|
Chiropractic practice was applied using the diversified technique, which is one of the types of chiropractic techniques.
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
|
|
Sham Comparator: placebo
sham manipulation applications
|
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
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.
|
|
Active Comparator: control
those who did not receive any intervention
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
5 weeks
|
|
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
|
5 weeks
|
|
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.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Deniz Balıkçı, Bahcesehir 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
- 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.
- Chaibi 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.
- Zengi 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.
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)
November 15, 2024
Primary Completion (Actual)
December 25, 2024
Study Completion (Actual)
January 2, 2025
Study Registration Dates
First Submitted
November 12, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Actual)
November 14, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 3, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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