Occupational ExposureNCT05752006
Chronic Adaptations to Spinal Flexion Exposure
A study testing Repeated trunk flexion in people with Occupational Exposure, run by University of Primorska at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Repeated trunk flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Aug 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, Primorska, 6310
About this study
Official title: 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.
Read the 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.
- Conditions
- Occupational Exposure
- Being tested
- Repeated trunk flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated trunk flexionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Crane operators | Experimental | Individuals employed as crane operators in Port of Koper. Receives: Other: Repeated trunk flexion |
| Control subjects | Active comparator | Individuals who spend more than half of their occupation time standing. Receives: Other: Repeated trunk flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (5)
Change in range of motion
Trunk flexion range of motion will be evaluated using Spinal Mouse in maximal trunk flexion while standing.
Measured: 90 minutes
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.
Measured: 90 minutes
Change in muscle activity
Muscle activity will be measured using electromyography during standing, a forward stoop hold and during maximal trunk flexion.
Measured: 90 minutes
Change in lumbar lordosis angle
The lumbar lordosis angle will be evaluated using Spinal Mouse during upright standing.
Measured: 90 minutes
Change in trunk extension maximal strength
Isometric trunk extension peak torque will be assessed on a trunk dynamometer.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start5 Aug 2023
- Primary completion30 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Voglar, University of Primorska
- Investigators
- Matej Voglar, PhD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752006
- Sponsor's protocol ID
- SWE_Flexion2_Crane
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded individual data will be uploaded on public scientific data repository.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Adaptations to Spinal Flexion Exposure in Crane Operators
- ClinicalTrials.gov ID
- NCT05752006
- Acronym / sponsor ID
- SWE_Flexion2_Crane
- Conditions
- Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Crane operators | Experimental | Other: Repeated trunk flexionIndividuals employed as crane operators in Port of Koper. |
| Control subjects | Active comparator | Other: Repeated trunk flexionIndividuals who spend more than half of their occupation time standing. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated trunk flexionA 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. | Other | Control subjects, Crane operators |
Primary outcome
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.
5 secondary outcomes
Change in range of motion
Time frame: 90 minutes
Change in length of the spine
Time frame: 90 minutes
Change in muscle activity
Time frame: 90 minutes
Change in lumbar lordosis angle
Time frame: 90 minutes
Change in trunk extension maximal strength
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Yes. Coded individual data will be uploaded on public scientific data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matej Voglar, PhD principal investigator
University of Primorska, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated trunk flexion in people with Occupational Exposure, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle stiffness (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.