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Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness

11. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Slowenien
      • Izola, Slowenien, 6310
        • Rekrutierung
        • University of Primorska, Faculty of Health Sciences, Izola
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: 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.
Verfahren: 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.
Aktiver Komparator: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
Verfahren: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Erector Spinae Muscle Stiffness
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Primorska

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. September 2026

Primärer Abschluss (Geschätzt)

26. November 2026

Studienabschluss (Geschätzt)

30. November 2026

Studienanmeldedaten

Zuerst eingereicht

11. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2026

Zuerst gepostet (Tatsächlich)

17. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • UP-FHS-PA-SWE-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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