- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05752006
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
Conditions
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.
Sponsor
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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