Chronic Adaptations to Spinal Flexion Exposure

Sponsor

University of Primorska (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05752006

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Occupational Exposure	Other: Repeated trunk flexion	N/A

Detailed Description

Our experimental study will include 40 participants, more specifically 20 crane operators and 20 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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Chronic Adaptations to Spinal Flexion Exposure in Crane Operators

Anticipated Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crane operators Individuals employed as crane operators in Port of Koper.	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.
Active Comparator: Control subjects Individuals who spend more than half of their occupation time standing.	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.

Arm

Intervention/Treatment

Experimental: Crane operators

Individuals employed as crane operators in Port of Koper.

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.

Active Comparator: Control subjects

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

Other: Repeated trunk flexion

Outcome Measures

Primary Outcome Measures

Change in muscle stiffness [90 min]
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 kilopasquals.

Secondary Outcome Measures

Change in range of motion [90 min]
Trunk flexion range of motion will be evaluated using Spinal Mouse during bending in standing position.
Change in length of the spine [90 min]
The length of spine will be measured on a custom-developed stadiometer, with the participants in a seated position.
Change in muscle activity [90 min]
Muscle activity will be measured using electromyography during standing, a forward stoop hold and during maximal trunk flexion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Primorska, Faculty of Health Sciences	Izola	Primorska	Slovenia	6310

Sponsors and Collaborators

University of Primorska

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MatejVoglar, Assistant professor, University of Primorska

ClinicalTrials.gov Identifier:

NCT05752006

Other Study ID Numbers:

SWE_Flexion2_Crane

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 2, 2023