ClinicalTrials.gg
RecruitingNCT07116720Updated Aug 12, 2025

Unloading Maneuvers During Spinal Flexion Exposure

An interventional study of Unloading maneuvers in Occupational Exposure, sponsored by University of Primorska. Recruiting at 1 site in Slovenia. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by University of Primorska · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
30 Years to 55 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Occupational Exposure
03

In context

Lead sponsor

University of Primorska is the lead sponsor of 56 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Occupational workers with a predominantly non static job (e.g. combination of sitting and standing)

Exclusion criteria

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
  • Sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control group

    Adult participants completing only the spinal flexion protocol

  • Experimental
    Intervention group

    Adult participants performing unloading maneuvers in between the spinal flexion protocol

    Other: Unloading maneuvers

Interventions

  • OtherUnloading maneuvers

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 90 minutes

Secondary outcomes

  1. Change in range of motion

    Trunk flexion range of motion will be evaluated using Spinal Mouse in maximal trunk flexion while standing.

    Time frame: 90 minutes

  2. Change in seated spinal height

    Seated spinal height will be measured on a custom-developed stadiometer, with the participants in a seated position.

    Time frame: 90 minutes

  3. Change in lumbar lordosis angle

    The lumbar lordosis angle will be evaluated using Spinal Mouse during upright standing.

    Time frame: 90 minutes

  4. Change in trunk extension maximal strength

    Isometric trunk extension peak torque will be assessed on a trunk dynamometer.

    Time frame: 90 minutes

07

Study locations

1 of 1 sites recruiting
  • Faculty of Health Sciences, University of Primorska
    Izola, Primorska 6310, Slovenia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Coded individual data will be uploaded on public scientific data repository.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2025
First posted
Aug 12, 2025
StartEst.
Aug 25, 2025
Primary completionEst.
Sep 30, 2025
CompletionEst.
Oct 15, 2025
Last update
Aug 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07116720
Lead sponsor
University of Primorska
Responsible party
Matej Voglar (Associate Professor, University of Primorska) — Principal investigator
First posted
Aug 12, 2025
Start date
Aug 25, 2025 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Oct 15, 2025 (estimated)
Last update
Aug 12, 2025

Study contacts

Matej Voglar, PhD
Contact
matej.voglar@fvz.upr.si
0038656635803
Rok Vatovec, PhD
Contact
rok.vatovec@fvz.upr.si
0038656635802

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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