ClinicalTrials.gg
RecruitingNCT07826260Updated Sep 17, 2026

Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness

An interventional study of Maitland Grade III++ Central Posteroanterior Mobilization and Sham Lumbar Mobilization in Muscle Stiffness, sponsored by University of Primorska. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University of Primorska · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.

In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.

Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.

02

Conditions studied

  • Muscle Stiffness

Keywords

  • Manual Therapy
  • Spinal Mobilization
  • Posteroanterior Mobilization
  • Maitland Mobilization
  • Muscle Stiffness
  • Shear Wave Elastography
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
18 Years to 45 Years
Sexes eligible
All
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

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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • .
  • Recent relevant trauma.
  • Joint instability.
  • Active rheumatoid arthritis.
  • Acute local or systemic infection.
  • Long-term local use.
  • Inability to assume or maintain the required testing position.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Mobilization-Sham Sequence

    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 Mobilization · Procedure: Sham Lumbar Mobilization

  • Active comparator
    Sham-Mobilization Sequence

    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 Mobilization · Procedure: Sham Lumbar Mobilization

Interventions

  • ProcedureMaitland Grade III++ Central Posteroanterior Mobilization

    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.

  • ProcedureSham Lumbar Mobilization

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately before and immediately after each intervention session

  2. 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.

    Time frame: Immediately before and immediately after each intervention session

Secondary outcomes

  1. Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry

    Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the erector spinae shear wave elastography assessment. Measurements will be performed immediately before and after each intervention condition. The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.

    Time frame: Immediately before and immediately after each intervention session

  2. Change in Multifidus Muscle Stiffness Assessed by Myotonometry

    Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the multifidus shear wave elastography assessment. Measurements will be performed immediately before and after each intervention condition. The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.

    Time frame: Immediately before and immediately after each intervention session

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07826260
Lead sponsor
University of Primorska
Responsible party
Žiga Kozinc (PhD, University of Primorska) — Principal investigator
First posted
Sep 17, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Nov 26, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Sep 17, 2026

Study contacts

Žiga Kozinc, PhD
Contact
ziga.kozinc@s2p.si
040161503 ext. +386

Oversight

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

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