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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

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.

Turkey (Türkiye)1 site

Pamukkale University
Denizli

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06841107
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.

3 Oct 202225 Jun 2024

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.
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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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