Occupational ExposureNCT07116720
Unloading Maneuvers During Spinal Flexion Exposure
A study testing Unloading maneuvers in people with Occupational Exposure, run by University of Primorska at 1 site in Slovenia.
Trial summary
An experimental study, which will aim to investigate the acute effects of unloading maneuvers during an intermittent spinal flexion protocol on changes in trunk mechanical and neuromuscular properties. 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?
- Unloading maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 25 Aug 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
- 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. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, University of Primorska
Izola, Primorska, 6310
Matej Voglar, PhD, 0038656635803, matej.voglar@fvz.upr.si
About this study
Official title: The Effect of Unloading Maneuvers During Spinal Flexion Exposure
An experimental study, which will aim to investigate the acute effects of unloading maneuvers during an intermittent spinal flexion protocol on changes in trunk mechanical and neuromuscular properties.
Read the detailed description
Our experimental study will include 30 participants. All participants will complete a 60-min intermittent spinal flexion protocol. During rest periods within the protocol, the participants from the intervention group will perform unloading maneuvers for the lumbar spine. Measurements of trunk mechanical and neuromuscular properties. will be performed prior to and following the 60-min protocol.
- Conditions
- Occupational Exposure
- Being tested
- Unloading maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unloading maneuversOther
Participants will perform unloading maneuvers four times with 15 min of spinal flexion protocol in between. The intervention will include self traction on a box (5 s) and sustained standing trunk extension (8 s). Both maneuvers will be repeated twice at each timepoint.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Adult participants completing only the spinal flexion protocol |
| Intervention group | Experimental | Adult participants performing unloading maneuvers in between the spinal flexion protocol Receives: Other: Unloading maneuvers |
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 (4)
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 seated spinal height
Seated spinal height will be measured on a custom-developed stadiometer, with the participants in a seated position.
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 posted12 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional study with intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Voglar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116720
- Sponsor's protocol ID
- SWE_Flexion3_Intervention
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Unloading Maneuvers During Spinal Flexion Exposure
- ClinicalTrials.gov ID
- NCT07116720
- Acronym / sponsor ID
- SWE_Flexion3_Intervention
- Conditions
- Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 12 Aug 2025 (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 investigate the acute effects of unloading maneuvers during an intermittent spinal flexion protocol on changes in trunk mechanical and neuromuscular properties.
Detailed description
Our experimental study will include 30 participants. All participants will complete a 60-min intermittent spinal flexion protocol. During rest periods within the protocol, the participants from the intervention group will perform unloading maneuvers for the lumbar spine. Measurements of trunk mechanical and neuromuscular properties. will be performed prior to and following the 60-min protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional study with intervention
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Adult participants completing only the spinal flexion protocol |
| Intervention group | Experimental | Other: Unloading maneuversAdult participants performing unloading maneuvers in between the spinal flexion protocol |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 |
|---|---|---|
| Unloading maneuversParticipants will perform unloading maneuvers four times with 15 min of spinal flexion protocol in between. The intervention will include self traction on a box (5 s) and sustained standing trunk extension (8 s). Both maneuvers will be repeated twice at each timepoint. | Other | Intervention group |
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.
4 secondary outcomes
Change in range of motion
Time frame: 90 minutes
Change in seated spinal height
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unloading maneuvers 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 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matej Voglar, PhD (0038656635803, matej.voglar@fvz.upr.si), or a site near the patient. 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 12 Aug 2025.