Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
Primary Purpose
Work-related Illness, Work Accident, Occupational Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
control
exercise group
Sponsored by
About this trial
This is an interventional treatment trial for Work-related Illness focused on measuring Workers, pain, exercise, ergonomics, Functionality
Eligibility Criteria
Inclusion Criteria: 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, Exclusion Criteria: Not being cooperative desk work Presence of psychological problems, Using sleeping pills Presence of neurological and orthopedic disease.
Sites / Locations
- Üsküdar Unıversıty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
exercise group
Arm Description
Only ergonomics training will be given to the control group.
Participants will be given training including stretching and core exercises along with ergonomics training.
Outcomes
Primary Outcome Measures
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).
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.
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.
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".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06004284
Brief Title
Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
Official Title
Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 18, 2023 (Actual)
Study Completion Date
October 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work-related Illness, Work Accident, Occupational Diseases
Keywords
Workers, pain, exercise, ergonomics, Functionality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be given exercise practices along with ergonomics training.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Only ergonomics training will be given to the control group.
Arm Title
exercise group
Arm Type
Experimental
Arm Description
Participants will be given training including stretching and core exercises along with ergonomics training.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The McGill Pain Questionnaire (MPQ)
Description
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).
Time Frame
10 weeks
Title
Oswestry Low Back Pain Disability Questionnaire
Description
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.
Time Frame
10 weeks
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
10 weeks
Title
The Pittsburgh Sleep Quality Index (PSQI)
Description
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".
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
Not being cooperative desk work
Presence of psychological problems,
Using sleeping pills
Presence of neurological and orthopedic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif PEHLEVAN
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Gebze
State/Province
Kocaeli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22087739
Citation
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.
Results Reference
background
PubMed Identifier
19219537
Citation
Bell 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.
Results Reference
background
PubMed Identifier
34633352
Citation
Biman 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.
Results Reference
background
PubMed Identifier
27849389
Citation
Coulombe 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.
Results Reference
background
PubMed Identifier
33049927
Citation
Abdollahi 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.
Results Reference
background
PubMed Identifier
22594388
Citation
Jaromi 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.
Results Reference
background
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Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality
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