Low Back Pain (LBP)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
A study testing Training was provided on spinal health. and Training on spinal health was provided and lumbar region support was applied for 3 months. in people with Low Back Pain (LBP) and Low Back Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Low Back Pain (LBP), Low Back Disorder
- What is being tested?
- Training was provided on spinal health. and Training on spinal health was provided and lumbar region support was applied for 3 months.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 25 Jun 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with back pain and discomfort
- Those who have been a bus driver for at least 1 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Low Back Pain (LBP), Low Back Disorder
- Being tested
- Training was provided on spinal health., Training on spinal health was provided and lumbar region support was applied for 3 months.
- Keywords
- Lumbar Region Support
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training was provided on spinal health.Other
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.
Training on spinal health was provided and lumbar region support was applied for 3 months.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal health training | Active comparator | 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. Receives: Other: Training was provided on spinal health. |
| Spinal health training and lumbar region support | Active comparator | 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. Receives: Other: Training on spinal health was provided and lumbar region support was applied for 3 months. |
| Control | No intervention | Control group; there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rapid Entire Body Assessment (REBA)
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.
Measured: 3 months
Extended Nordic Musculoskeletal Questionnaire
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start3 Oct 2022
- Primary completion28 Dec 2023
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 1. group was given training on spinal health. 2. group was given lumbar region support along with training on spine health. 3. group (control group) received no intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Arık, Pamukkale University
- Investigators
- Ali Kitiş, Professor, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841107
- Sponsor's protocol ID
- E-60116787-020-244556
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06841107
- Acronym / sponsor ID
- E-60116787-020-244556
- Conditions
- Low Back Pain (LBP), Low Back Disorder
- Keywords
- Lumbar Region Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 24 Feb 2025 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1. group was given training on spinal health. 2. group was given lumbar region support along with training on spine health. 3. group (control group) received no intervention.
| Arm | Type | Receives |
|---|---|---|
| Spinal health training | Active comparator | Other: Training was provided on spinal health.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. |
| Spinal health training and lumbar region support | Active comparator | Other: Training on spinal health was provided and lumbar region support was applied for 3 months.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. |
| Control | No intervention | –Control group; there is no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those with back pain and discomfort
- Those who have been a bus driver for at least 1 year
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Training was provided on 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. | Other | Spinal health training |
| Training on spinal health was provided and lumbar region support was applied 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. | Other | Spinal health training and lumbar region support |
Primary outcome
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.
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.
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 24 Feb 2025.
Related trials for Low Back Pain (LBP)
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
RecruitingObservational study
Exploring Multidimensional Trajectories in People With Low Back Pain
Acute Low Back Pain, Chronic Low Back Pain (CLBP)
Active, not recruitingPhase 3
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
MSK Conditions, Chronic Low Back Pain (CLBP)
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.
Ali Kitiş, Professor study director
Pamukkale 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 Training was provided on spinal health. and Training on spinal health was provided and lumbar region support was applied for 3 months. in people with Low Back Pain (LBP) and Low Back Disorder, run by Pamukkale 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 2 inclusion and 5 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 24 Feb 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. 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 Rapid Entire Body Assessment (REBA) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.