NCT06864650

Brief Summary

This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

March 3, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    14 weeks

  • The Pittsburgh Sleep Quality Index

    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

    14 weeks

  • Short form of the International Physical Activity Questionnaire

    It consists of 8 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities.

    14 weeks

Study Arms (2)

Ergonomics training

ACTIVE COMPARATOR

group without any intervention

Other: Ergonomics training

Ergonomics training +exercise program

EXPERIMENTAL

The group that followed the 12-week exercise program

Other: Ergonomics trainingOther: exercise program

Interventions

Each of the control group participants will receive separate ergonomics training. The content of this training will include the topics of "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk factors."

Ergonomics trainingErgonomics training +exercise program

stretching exercises strengthening exercises waist exercises core exercises relaxation exercises

Ergonomics training +exercise program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18-60 years old
  • Having worked in the same factory for at least 2 years
  • Working full time
  • Having complained of back pain for at least 3 months
  • visual analog scale\>4, pain 4 and above on visual analog scale

You may not qualify if:

  • Being under 18 years old or over 60 years old
  • Having worked for less than 2 years
  • Working part time
  • Having complained of back pain for less than 3 months
  • visual analog scale Presence of psychological problems
  • Using sleeping pills
  • Having undergone surgical intervention in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valeo Vision System

Galway, Ireland

Location

Related Publications (3)

  • Stieglitz DD, Vinson DR, Hampton MC. Equipment-based Pilates reduces work-related chronic low back pain and disability: A pilot study. J Bodyw Mov Ther. 2016 Jan;20(1):74-82. doi: 10.1016/j.jbmt.2015.06.006. Epub 2015 Jun 15.

    PMID: 26891640BACKGROUND
  • Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.

    PMID: 29321099BACKGROUND
  • Pehlevan E, Sevgin O. Effect of exercise given to factory workers with ergonomics training on pain and functionality: A randomized controlled trial. Work. 2024;78(1):195-205. doi: 10.3233/WOR-230663.

    PMID: 38701125BACKGROUND

MeSH Terms

Interventions

ErgonomicsResistance Training

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kübra TOSYALI

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 7, 2025

Study Start

March 25, 2025

Primary Completion

June 25, 2025

Study Completion

August 10, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations