NCT07826260

Brief Summary

This randomized controlled crossover study will investigate the immediate effect of central posteroanterior lumbar mobilization on the intrinsic stiffness of the erector spinae and multifidus muscles in healthy adults without low back pain. Twenty-four participants will complete two experimental visits in randomized order. During one visit, participants will receive Maitland Grade III++ central posteroanterior mobilization at the L4 vertebral level, while during the other visit they will receive a sham mobilization condition involving gentle rhythmic pressure. Muscle stiffness will be assessed using shear wave elastography immediately before and after each intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Muscle Stiffness

Keywords

Manual TherapySpinal MobilizationPosteroanterior MobilizationMaitland MobilizationMuscle StiffnessShear Wave Elastography

Outcome Measures

Primary Outcomes (2)

  • Change in Erector Spinae Muscle Stiffness

    Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.

    Immediately before and immediately after each intervention session

  • Change in Multifidus Muscle Stiffness

    Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.

    Immediately before and immediately after each intervention session

Secondary Outcomes (2)

  • Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry

    Immediately before and immediately after each intervention session

  • Change in Multifidus Muscle Stiffness Assessed by Myotonometry

    Immediately before and immediately after each intervention session

Study Arms (2)

Mobilization-Sham Sequence

EXPERIMENTAL

Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.

Procedure: Maitland Grade III++ Central Posteroanterior MobilizationProcedure: Sham Lumbar Mobilization

Sham-Mobilization Sequence

ACTIVE COMPARATOR

Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.

Procedure: Maitland Grade III++ Central Posteroanterior MobilizationProcedure: Sham Lumbar Mobilization

Interventions

Maitland Grade III++ Central Posteroanterior MobilizationPROCEDURE

Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position. The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.

Mobilization-Sham SequenceSham-Mobilization Sequence
Sham Lumbar MobilizationPROCEDURE

Sham mobilization is applied over the L4 spinous process with the participant in a prone position. The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets. The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.

Mobilization-Sham SequenceSham-Mobilization Sequence

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 21 to 38 years.
  • Resident of the Republic of Slovenia.
  • No current low back pain.
  • No contraindications to lumbar manual mobilization.
  • Ability to assume and maintain the required prone testing position.
  • Provision of written informed consent.

You may not qualify if:

  • Current low back pain.
  • Spondylolisthesis.
  • Severe osteoporosis.
  • Spinal stenosis.
  • Lumboischialgia or other significant structural spinal deformity.
  • Fibromyalgia.
  • Recent spinal surgery or lumbar spinal fixation.
  • Cauda equina syndrome.
  • Nerve root compression associated with neurological deficits.
  • Malignancy.
  • Recent relevant trauma.
  • Joint instability.
  • Active rheumatoid arthritis.
  • Acute local or systemic infection.
  • Long-term local corticosteroid use.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences, Izola

Izola, 6310, Slovenia

RECRUITING

Central Study Contacts

Žiga Kozinc, PhD

CONTACT

040161503ziga.kozinc@s2p.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will complete both intervention conditions during two separate study visits. The order of Maitland Grade III++ central posteroanterior mobilization and sham mobilization will berandomized, with the alternate condition administered during the second visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in subsequent publications may be made available upon reasonable request to the study investigators. Data will be shared for scientifically justified purposes following approval by the investigators and, where appropriate, completion of a data-sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available following publication of the main study results and will remain available for at least 5 years.
Access Criteria
Researchers with a scientifically justified proposal may request access. Requests will be reviewed by the study investigators and data will be shared in de-identified form subject to applicable ethical and data-protection requirements.

Locations

SL(1)