Chronic Adaptations to Spinal Flexion Exposure

Occupational Exposure Clinical Trial

Official title:

Chronic Adaptations to Spinal Flexion Exposure in Crane Operators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752006
• Other study ID #: SWE_Flexion2_Crane
• Status: Completed
• Phase: N/A
• Start date: August 5, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: October 2023
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Occupational Exposure

Intervention

Other:
• Repeated trunk flexion
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.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola	Primorska

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

Outcome

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