Chronic Adaptations to Spinal Flexion Exposure

March 26, 2024 updated by: Matej Voglar, University of Primorska

Chronic Adaptations to Spinal Flexion Exposure in Crane Operators

An experimental study, which will aim to compare changes of trunk mechanical properties and neuromuscular control following spinal flexion exposure in crane operators and control subjects.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Our experimental study will include 40 participants, more specifically 15 crane operators and 15 control subjects. All participants will complete a 60-min protocol of intermittent trunk flexion. Measurements of trunk mechanical properties and neuromuscular control will be performed prior to and following the 60-min protocol.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Primorska
      • Izola, Primorska, Slovenia, 6310
        • University of Primorska, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Crane operators: employed as crane operators for more than 3 years
  • Occupational workers with a predominantly non static job (e.g. combination of sitting and standing)

Exclusion Criteria:

  • History of chronic low back pain
  • Episode of acute low back pain
  • Hip injury in the past six months
  • Previous spine, pelvis or hip surgery
  • Hypermobility, diagnosed with the Beighton score
  • High intensity resistance training (> 75 % of 1 repetition maximum) more than two times a week
  • Control group: sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crane operators
Individuals employed as crane operators in Port of Koper.
A 60-min intermittent trunk flexion protocol. Participants will sit on a standard height sit, with their knees bent at approximately 90° with their hands crossed on their chest. They will perform 40 sets of 60 s of maintaining a flexed position, interspersed with 30 s of rest. Participants will achieve the flexed position by tilting the pelvis posteriorly and leaning forward. During rest, participants will sit up straight without leaning on the support.
Active Comparator: Control subjects
Individuals who spend more than half of their occupation time standing.
A 60-min intermittent trunk flexion protocol. Participants will sit on a standard height sit, with their knees bent at approximately 90° with their hands crossed on their chest. They will perform 40 sets of 60 s of maintaining a flexed position, interspersed with 30 s of rest. Participants will achieve the flexed position by tilting the pelvis posteriorly and leaning forward. During rest, participants will sit up straight without leaning on the support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle stiffness
Time Frame: 90 minutes
Muscle stiffness will be measured using ultrasound-based shear wave elastography during prone lying and forward stooping. Erector spinae and multifidus muscle stiffness will be expressed as the shear modulus value in kilopascals.
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in length of the spine
Time Frame: 90 minutes
The length of spine will be measured on a custom-developed stadiometer, with the participants in a seated position.
90 minutes
Change in range of motion
Time Frame: 90 minutes
Trunk flexion range of motion will be evaluated using Spinal Mouse in maximal trunk flexion while standing.
90 minutes
Change in muscle activity
Time Frame: 90 minutes
Muscle activity will be measured using electromyography during standing, a forward stoop hold and during maximal trunk flexion.
90 minutes
Change in lumbar lordosis angle
Time Frame: 90 minutes
The lumbar lordosis angle will be evaluated using Spinal Mouse during upright standing.
90 minutes
Change in trunk extension maximal strength
Time Frame: 90 minutes
Isometric trunk extension peak torque will be assessed on a trunk dynamometer.
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matej Voglar, PhD, University of Primorska, Faculty of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SWE_Flexion2_Crane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Coded individual data will be uploaded on public scientific data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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