Unloading Maneuvers During Spinal Flexion Exposure

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.

Study Overview

• Status: Recruiting
• Conditions: Occupational Exposure
• Intervention / Treatment: Other: Unloading maneuvers

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matej Voglar, PhD; Phone Number: 0038656635803; Email: matej.voglar@fvz.upr.si
• Study Contact Backup: Name: Rok Vatovec, PhD; Phone Number: 0038656635802; Email: rok.vatovec@fvz.upr.si

Study Locations

• Slovenia
  • Primorska
    • Izola, Primorska, Slovenia, 6310
      • Recruiting
      • Faculty of Health Sciences, University of Primorska
      • Contact: Matej Voglar, PhD; Phone Number: 0038656635803; Email: matej.voglar@fvz.upr.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in range of motion	Trunk flexion range of motion will be evaluated using Spinal Mouse in maximal trunk flexion while standing.	90 minutes
Change in lumbar lordosis angle	The lumbar lordosis angle will be evaluated using Spinal Mouse during upright standing.	90 minutes
Change in trunk extension maximal strength	Isometric trunk extension peak torque will be assessed on a trunk dynamometer.	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.	90 minutes

Collaborators and Investigators

• Sponsor: University of Primorska

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: August 6, 2025
• First Posted (Actual): August 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SWE_Flexion3_Intervention

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