NCT06841107

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 25, 2025

Last Update Submit

February 19, 2025

Conditions

Keywords

Lumbar Region Support

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Study Arms (3)

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.

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.

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.

Interventions

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.

Spinal health training

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.

Spinal health training and lumbar region support

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those with back pain and discomfort
  • Those who have been a bus driver for at least 1 year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Kitiş, Professor

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2025

First Posted

February 24, 2025

Study Start

October 3, 2022

Primary Completion

December 28, 2023

Study Completion

June 25, 2024

Last Updated

February 24, 2025

Record last verified: 2025-01

Locations