Chronic Adaptations to Spinal Flexion Exposure

NCT05752006 | Completed

• 1 other identifier: SWE_Flexion2_Crane
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Occupational Exposure

Outcome Measures

Primary Outcomes (1)

• Change in muscle stiffness

  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 Outcomes (5)

• Change in range of motion

  90 minutes

• Change in length of the spine

  90 minutes

• Change in muscle activity

  90 minutes

• Change in lumbar lordosis angle

  90 minutes

• Change in trunk extension maximal strength

  90 minutes

Study Arms (2)

Crane operators

EXPERIMENTAL

Individuals employed as crane operators in Port of Koper.

Other: Repeated trunk flexion

Control subjects

ACTIVE COMPARATOR

Individuals who spend more than half of their occupation time standing.

Other: Repeated trunk flexion

Interventions

Repeated trunk flexion OTHER

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.

Control subjects; Crane operators

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Only male participants will be included, due to gender specificity of crane operators.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, Primorska, 6310, Slovenia

Location

Study Officials

• Matej Voglar, PhD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Cross-sectional study

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: August 5, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 15, 2023
• Last Updated: March 28, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SL (1)