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NCT Number: NCT07116720

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.

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Key information

Conditions

Occupational Exposure

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, University of Primorska

Izola, Primorska, 6310, Slovenia

Location status: Recruiting

Location contact

Matej Voglar, PhD

CONTACT

[email protected]

0038656635803

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Unloading maneuvers

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in seated spinal height

    Time frame: 90 minutes

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

  3. Change in lumbar lordosis angle

    Time frame: 90 minutes

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

  4. Change in trunk extension maximal strength

    Time frame: 90 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Matej Voglar, PhD

CONTACT

[email protected]

0038656635803

Rok Vatovec, PhD

CONTACT

[email protected]

0038656635802

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

The Effect of Unloading Maneuvers During Spinal Flexion Exposure

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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