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Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness

11 settembre 2026 aggiornato da: Žiga Kozinc, University of Primorska

Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Slovenia
      • Izola, Slovenia, 6310
        • Reclutamento
        • University of Primorska, Faculty of Health Sciences, Izola
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 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.

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.
  • Malignancy.
  • Recent relevant trauma.
  • Joint instability.
  • Active rheumatoid arthritis.
  • Acute local or systemic infection.
  • Long-term local corticosteroid use.
  • Inability to assume or maintain the required testing position.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Mobilization-Sham Sequence
Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.
Procedura: Maitland 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.
Procedura: Sham 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.
Comparatore attivo: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
Procedura: Maitland 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.
Procedura: Sham 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Erector Spinae Muscle Stiffness
Lasso di tempo: Immediately before and immediately after each intervention session
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
Lasso di tempo: Immediately before and immediately after each intervention session
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Lasso di tempo: Immediately before and immediately after each intervention session
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.
Immediately before and immediately after each intervention session
Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Lasso di tempo: Immediately before and immediately after each intervention session
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.
Immediately before and immediately after each intervention session

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Primorska

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

26 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

11 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 settembre 2026

Primo Inserito (Effettivo)

17 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UP-FHS-PA-SWE-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Data will be available following publication of the main study results and will remain available for at least 5 years.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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