NCT07745400

Brief Summary

Background: Musculoskeletal disorders are common occupational health problems among industrial workers, particularly manual material handlers involved in repetitive lifting and physical tasks. Ergonomic education and postural awareness interventions are frequently used to prevent these disorders, but long-term follow-up data regarding their effectiveness remain limited. Purpose: The main objective of this study was to evaluate the 12-month effectiveness of an intensive ergonomic education and postural awareness program on musculoskeletal symptoms, ergonomic risk levels, handling posture, and knowledge levels among manual material handlers. Methods: In this randomized controlled trial, participants were randomly allocated into two groups: an Intervention Group and a Control Group. The Intervention Group received comprehensive theoretical and practical ergonomic education focused on safe material handling and postural awareness, followed by regular follow-ups and reminders. The Control Group received baseline assessments without ongoing postural reinforcement. Outcome measures-including musculoskeletal symptom severity, ergonomic posture risk, and ergonomic knowledge-were evaluated at baseline, 3rd, 6th, 9th, and 12th months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2016

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2016

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

musculoskeletal symptomsworking postureManual Material HandlersPostural AwarenessLong-term Follow-upergonomic interventionBlue-Collar Workers

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Rapid Entire Body Assessment (REBA) Score

    REBA is an observational tool used to assess ergonomic risk levels related to working postures. It evaluates body posture (trunk, neck, legs, upper arms, lower arms, and wrists), load/force, and coupling. Total scores range from 1 to 15, with higher scores indicating higher ergonomic risk levels.

    Baseline, Post-intervention 3rd month, 6th month, 9th month, and 12th month

  • Change from Baseline in Ergonomics Score (EP) derived from Dutch Musculoskeletal Questionnaire Short Form (DMQ-SF)

    The Ergonomics Score (EP) evaluates exposure to physical working conditions and postural risk factors based on 8 questions (24 statements) of the DMQ-SF. Raw scores are normalized to a 0-100 scale using Min-Max Normalization: EP = ((Raw Score - 24) / 24) \* 100. Higher scores represent greater exposure to ergonomic risk factors.

    Baseline, Post-intervention 3rd month, 6th month, 9th month, and 12th month

Secondary Outcomes (1)

  • Change from Baseline in Musculoskeletal Knowledge Score (MKS)

    Baseline, Immediately Post-intervention, 3rd month, 6th month, 9th month, and 12th month

Study Arms (3)

Experiential Learning Group (ELG)

EXPERIMENTAL

Participants (n=22) in this arm received an interactive, 8-hour ergonomic education program based on Kolb's Experiential Learning Theory, specifically designed to prevent work-related musculoskeletal disorders and mitigate ergonomic risks. The training incorporated situation-based scenarios, role-playing, peer-interactive games, and practical motor-skill training for a 10-exercise home exercise program. Outcome assessments were conducted over a 12-month period (Baseline, Post-intervention, 3rd, 6th, 9th, and 12th months).

Behavioral: Experiential Learning-Based Ergonomic Training Program

Seminar Group (SG)

ACTIVE COMPARATOR

Participants (n=22) in this arm received a standard 6-hour classroom-based traditional ergonomic seminar education. The session covered the exact same core ergonomic curriculum and home exercise program as the ELG, delivered through didactic lectures, slide presentations, and question-and-answer sessions without interactive practical group exercises. Outcome assessments were conducted over a 12-month period (Baseline, Post-intervention, 3rd, 6th, 9th, and 12th months).

Behavioral: Traditional Ergonomic Seminar Education

Control Group (CG)

NO INTERVENTION

Participants (n=26) in this arm received no educational or practical intervention during the 12-month study period and maintained their routine work activities. Outcome assessments were conducted prospectively at the exact same follow-up time points as the intervention groups (Baseline, 3rd, 6th, 9th, and 12th months).

Interventions

A standard 6-hour classroom-based traditional ergonomic education seminar covering the exact same core ergonomic curriculum and 10-exercise home exercise program, delivered through didactic lectures, slide presentations, and question-and-answer sessions without interactive practical group exercises.

Seminar Group (SG)

An interactive 8-hour ergonomic training program based on Kolb's Experiential Learning Theory, including situation-based scenarios, role-playing, peer-interactive games, and practical motor-skill training for a 10-exercise home exercise program.

Experiential Learning Group (ELG)

Eligibility Criteria

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

You may qualify if:

  • Having performed manual material handling tasks for at least the last 12 months.
  • Having worked at least 30 hours per week in tasks requiring the use of upper extremities and hands.
  • Voluntarily participating in the study and signing the informed consent form.

You may not qualify if:

  • Having received training in musculoskeletal disorders (MSDs) or ergonomics within the last 6 months.
  • Having received medical treatment for MSDs within the last 6 months.
  • Using medications that may affect muscle tone or balance.
  • Having a congenital or acquired physical disability that causes functional limitation.
  • Having a Body Mass Index less than 20 kg/m² or greater than 35 kg/m².
  • Having joint restriction in the extremities or spine.
  • Having a neurological or rheumatic disease.
  • Having a score of 30 or higher on the Beck Depression Inventory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nezire Köse, PhD, PT

    Hacettepe University Faculty of Physical Therapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To minimize outcome assessment bias, the primary evaluator was masked to group allocations during all physical and observational data collections. For observational risk assessments (e.g., REBA), scoring and posture evaluations were completed independently prior to checking participant identification and group assignment records.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly allocated into three parallel groups: Experiential Learning Group (ELG): Received an interactive, experience-based ergonomic education program specifically designed to prevent work-related musculoskeletal disorders and mitigate ergonomic risks. Seminar Group (SG): Received standard classroom-based traditional seminar education covering the exact same core ergonomic content and principles as the ELG. Control Group (CG): Received baseline assessments only without educational intervention during the study period. All three groups were prospectively evaluated at Baseline, 3rd, 6th, 9th, and 12th months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

January 19, 2015

Primary Completion

February 15, 2016

Study Completion

February 26, 2016

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared to protect participant privacy and confidentiality, in accordance with the ethical approval and informed consent agreements. De-identified aggregate data will be made available upon reasonable request to the corresponding author for scientific research purposes.