- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07826260
Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Žiga Kozinc, PhD
- Numéro de téléphone: +386 040161503
- E-mail: ziga.kozinc@s2p.si
Lieux d'étude
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Izola, Slovénie, 6310
- Recrutement
- University of Primorska, Faculty of Health Sciences, Izola
-
Contact:
- Žiga Kozinc, PhD
- Numéro de téléphone: +386 040161503
- E-mail: ziga.kozinc@s2p.si
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Mobilization-Sham Sequence
Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.
|
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.
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.
|
|
Comparateur actif: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
|
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.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Erector Spinae Muscle Stiffness
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UP-FHS-PA-SWE-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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