NCT06004284

Brief Summary

The aim of this study is to evaluate the effects of ergonomics training with exercises applied on factory workers with low back pain on pain, functionality, sleep and fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

WorkerspainexerciseergonomicsFunctionality

Outcome Measures

Primary Outcomes (4)

  • The McGill Pain Questionnaire (MPQ)

    McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the VAS, and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).

    10 weeks

  • 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.

    10 weeks

  • Fatigue Severity Scale (FSS)

    This scale consists of 9 questions and each option has a score between 0-7. A score of 0 is expressed as "strongly disagree", while a score of 7 is expressed as "agree". The maximum score is 7, and it is recorded that people have a significant degree of fatigue for 4 points and above.

    10 weeks

  • The Pittsburgh Sleep Quality Index (PSQI)

    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".

    10 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Only ergonomics training will be given to the control group.

Other: control

exercise group

EXPERIMENTAL

Participants will be given training including stretching and core exercises along with ergonomics training.

Other: exercise group

Interventions

controlOTHER

Ergonomics training will be given to each of the control group participants individually. The content of this training will include "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa

control group

The exercise training program will be applied for 8 weeks, 3 days a week and for an average of 20-30 minutes. After the maneuver is taught, stretching exercises lasting 5 minutes for warm-up purposes and posture and core exercises lasting 25 minutes will be taught. Among the stretching exercises, quadratus lumborum stretching, hamstring stretching, erector spina stretching, hip extensor stretching exercises will be applied. Posterior pelvic tilt exercise will be performed as a control and smoothing exercise for the vertebrae of the lumbar and pelvic region. Among the core stabilization exercises, bridging, plank, plank in side lying, abdominal strengthening, cross arm leg lifting exercises in crawling position will be performed. Each exercise position will be required to be maintained for 8 seconds and to do 10-15 repetitions.

exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be between the ages of 18-65,
  • Having low back pain in the last 3 months
  • Visual Pain Scale (VAS) \>4
  • No surgical intervention in the last 6 months,

You may not qualify if:

  • Not being cooperative desk work
  • Presence of psychological problems,
  • Using sleeping pills
  • Presence of neurological and orthopedic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Gebze, Kocaeli, Turkey (Türkiye)

Location

Related Publications (6)

  • Erick PN, Smith DR. A systematic review of musculoskeletal disorders among school teachers. BMC Musculoskelet Disord. 2011 Nov 17;12:260. doi: 10.1186/1471-2474-12-260.

    PMID: 22087739BACKGROUND
  • Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009 Mar;19(1):8-24. doi: 10.1007/s10926-009-9164-5. Epub 2009 Feb 14.

    PMID: 19219537BACKGROUND
  • Biman S, Maharana S, Metri KG, Nagaratna R. Effects of yoga on stress, fatigue, musculoskeletal pain, and the quality of life among employees of diamond industry: A new approach in employee wellness. Work. 2021;70(2):521-529. doi: 10.3233/WOR-213589.

    PMID: 34633352BACKGROUND
  • Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.

    PMID: 27849389BACKGROUND
  • Abdollahi T, Pedram Razi S, Pahlevan D, Yekaninejad MS, Amaniyan S, Leibold Sieloff C, Vaismoradi M. Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2020 Oct 8;17(19):7333. doi: 10.3390/ijerph17197333.

    PMID: 33049927BACKGROUND
  • Jaromi M, Nemeth A, Kranicz J, Laczko T, Betlehem J. Treatment and ergonomics training of work-related lower back pain and body posture problems for nurses. J Clin Nurs. 2012 Jun;21(11-12):1776-84. doi: 10.1111/j.1365-2702.2012.04089.x.

    PMID: 22594388BACKGROUND

MeSH Terms

Conditions

Occupational DiseasesPainMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Elif PEHLEVAN

    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
Model Details: Participants will be given exercise practices along with ergonomics training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

October 18, 2023

Study Completion

October 18, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations