- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06841107
Investigation of the Effect of Spine Health Training and Lumbar Region Support on Back Pain and Discomfort in City Bus Drivers: a Randomized Controlled Trial
The World Health Organization (WHO) classifies driving as a function of daily activities and social participation. Professional bus drivers have an important place in society for transportation. Drivers are seen as a stressful occupational group due to their use of the vehicle in the same position and intensive working hours.
It is important for bus drivers not to feel discomfort during long working hours and to choose the right seat position. Because the design of the driver's seat directly affects the driver's spine biomechanics. For an ergonomic posture, the head, back and waist areas of the driver's seats should be well supported. During driving, the waist and back of the seat should be supported in order to fix the driver's lumbar region due to movements in the vehicle seat.
Professional drivers' long working hours, sitting positions and exposure to vibration, work stress, short breaks, and insufficient physical activity bring about occupational diseases. Musculoskeletal disorders are seen primarily, as well as hypertension, diabetes, cardiovascular diseases, etc. Most musculoskeletal problems are caused by incorrect sitting positions. In many studies, it is seen that drivers have neck, upper back and waist pain, and spinal problems. The main reason for musculoskeletal disorders is that the seats are not adjustable and most drivers try to maintain their posture with additional supports. When the studies conducted look at the relationship between the driver and the seat during long-term vehicle use, the pressure in the contact areas, insufficient support in the back and waist area causes a decrease in comfort, thus causing back and waist discomfort and pain in the individual.
Psychosocial factors are also risk factors affecting musculoskeletal disorders. It has been observed that stress causes various diseases including heart disease, gastrointestinal diseases, and musculoskeletal disorders in city bus drivers. Psychosocial factors such as job satisfaction, burnout, and stress have been found to be associated with the incidence of musculoskeletal disorders.
Eliminating the back pain and discomfort of professional drivers, who occupy a large place in society, will provide great benefits both for the health of individuals and to alleviate the burden on the service sector. In studies in the international literature on this subject, only posture analyses of drivers have been conducted or the effects on pain and discomfort in the short term after the intervention have been examined. In the literature, drivers stated that seats with lumbo-sacral support were more comfortable than standard seats. In this study, the effect on pain and discomfort will be examined by following the drivers for 3 months. The aim of this study is to examine the effectiveness of the use of lumbar region support in bus drivers by following them for 3 months in terms of back pain and discomfort caused by long working hours and incorrect posture.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those with back pain and discomfort
- Those who have been a bus driver for at least 1 year
Exclusion Criteria:
- Having been a bus driver for less than 1 year
- Having any orthopedic, neurological, rheumatological or metabolic disease diagnosed due to back pain
- Having had spinal surgery
- Using medication for a diagnosed back problem
- Having received physiotherapy/physical therapy for a diagnosed back pain problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Spinal health training
It focuses on basic body knowledge, correct posture and spinal health; common spinal problems, especially in drivers, and their prevention.
It covers how a healthy spine should look like, what to look out for during and after working hours, correct driver seat adjustments and stretching and strengthening exercises to maintain spinal health.
|
Bus drivers were told about the practices they could do during and outside of work hours, and were asked to comply with these practices every day for 3 months.
|
|
Active Comparator: Spinal health training and lumbar region support
It focuses on basic body knowledge, correct posture and spinal health; common spinal problems, especially in drivers, and their prevention.
It covers how a healthy spine should look like, what to look out for during and after working hours, correct driver seat adjustments and stretching and strengthening exercises to maintain spinal health.
In addition, lumbar region support was used during working hours for 3 months.
|
Bus drivers were told about the practices they could do during and outside of work hours, and were asked to comply with these practices every day for 3 months.
In addition, lumbar region support was used every day during working hours for 3 months.
|
|
No Intervention: Control
Control group; there is no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Rapid Entire Body Assessment (REBA)
Time Frame: 3 months
|
Posture assessment was performed before the intervention and after three months of lumbar support use. The Rapid Entire Body Assessment (REBA) assesses the risk of musculoskeletal disorders by analyzing body posture during work. It rates the level of risk on a scale of 1 to 15, with higher scores indicating a higher risk of musculoskeletal disorders due to poor posture. This assessment was used to demonstrate the impact of posture on low back pain and discomfort. |
3 months
|
|
Extended Nordic Musculoskeletal Questionnaire
Time Frame: 3 months
|
A musculoskeletal questionnaire was conducted before the intervention and 3 months after the spine health training.
The Extended Nordic Musculoskeletal Questionnaire was used to assess musculoskeletal disorders.
This questionnaire collects information about current, past month and past 12 months musculoskeletal problems in nine different parts of the body (neck, shoulder, elbow, hand/wrist, back, waist, hip/thigh, knee, foot/ankle).
It also collects information on how often these pains/discomforts occur, whether they decrease on vacation days and the severity of the pain.
This questionnaire was used to evaluate the effectiveness of spine health training.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ali Kitiş, Professor, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-244556
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Low Back Disorder
-
Francis FarhadiDePuy SynthesCompleted
-
University of Southern CaliforniaCompleted
-
Cesar A Hincapié, DC PhDEpidemiology, Biostatistics and Prevention Institute, University of ZurichCompletedBack Pain | Back Pain, Low | Back DisorderSwitzerland
-
Karolinska InstitutetStiftelsen RönnbäretRecruiting
-
University of WaterlooCBI HealthCompletedMusculoskeletal Injury | Shoulder Disease | Low Back DisorderCanada
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Keiser University College of Chiropractic MedicineCompletedLow Back Pain | Cervical Pain | Spine Injury | Neck Disorder | Low Back DisorderUnited States
-
October 6 UniversityRecruiting
-
Molde University CollegeNorwegian National Advisory Unit on Occupational RehabilitationActive, not recruitingDepression | Musculoskeletal Diseases | Anxiety Disorders | Mental Health Disorder | Back Pain, LowNorway
-
Riphah International UniversityCompleted
Clinical Trials on Training was provided on spinal health.
-
Merve AkmanZonguldak Bulent Ecevit UniversityCompletedMental Health LiteracyTurkey (Türkiye)
-
Biruni UniversityCompletedOveractive Bladder
-
Dylan FinnertyUnknown
-
Celal Bayar UniversityCompletedQuality of Life | Sleep QualityTurkey
-
YuanYuan MaCompleted
-
Ataturk UniversityCompleted
-
Yuzuncu Yıl UniversityAtaturk UniversityCompletedType2 Diabetes MellitusTurkey
-
KDH Research & CommunicationNational Institute on Minority Health and Health Disparities (NIMHD)CompletedChild | Self Efficacy | Oral Health | Health Literacy | Attitude | Intention | Adolescents | Knowledge | Community Health Workers | African Americans | PovertyUnited States
-
Kahramanmaraş İstiklal UniversityNot yet recruitingMotivational Interviewing | Women | Health Care Seeking Behavior | Migrants
-
Junyan ZhaoActive, not recruitingStomach Cancer | Breast Cancer | Lung Cancer | Rectal Cancer | Colon Cancer | Liver CancerChina