Unloading Maneuvers During Spinal Flexion Exposure

NCT07116720 | Recruiting

• 1 other identifier: SWE_Flexion3_Intervention
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Occupational Exposure

Outcome Measures

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.

  90 minutes

Secondary Outcomes (4)

• Change in range of motion

  90 minutes

• Change in seated spinal height

  90 minutes

• Change in lumbar lordosis angle

  90 minutes

• Change in trunk extension maximal strength

  90 minutes

Study Arms (2)

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

Other: Unloading maneuvers

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

Faculty of Health Sciences, University of Primorska

Izola, Primorska, 6310, Slovenia

RECRUITING

Central Study Contacts

Matej Voglar, PhD

CONTACT

0038656635803; matej.voglar@fvz.upr.si

Rok Vatovec, PhD

CONTACT

0038656635802; rok.vatovec@fvz.upr.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cross-sectional study with intervention

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 12, 2025
• Study Start: August 25, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SL (1)