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Extending Ultrasound Elastography to Manual Treatment Methods

21 septembre 2012 mis à jour par: Canadian Memorial Chiropractic College

Manual treatment offers benefit to some patients suffering from back pain but little is known about which of the many tissue layers are affected. This study will help identify which tissues may be stimulated sufficiently to be a source for the clinical effects of treatment and to prioritize future work to understand mechanisms of back pain and to improve care.

Current soft-tissue ultrasound elastography techniques, under static condition, will be extended to quantify relative displacement and strains(active and passive)across the depth of tissue strata that arise from small amplitude motions during continuous passive motion clinical procedures and in weight bearing postures. Relative movement of the stratified layers of the back, from treatment and task-generated perturbations, will enable the elastography interrogation of the tissue.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

  1. Tissue displacement and strain differs dependent on comparable tasks, in recumbent vs upright postures and muscular activation.

    - Refine motion tracking and stabilization of manual elastography, used in preliminary study, to evaluate layered tissue strain patterns during clinical continuous passive motion (flexion, extension and lateral bending) and standardized weight bearing (stance, flexion to 15 degrees and arm-extended weight holding).

  2. Relative muscle activity is significantly related to muscle strain ratio.

    - Evaluate the biceps as a simple model, in parallel, for displacement and elastography changes.

  3. Displacement and strain decrease monotonically as depth of paraspinal tissue from the surface increases.

    - Evaluate the timing relationship of total passive loads, myoelectric paraspinal behavior displacement/strain characteristics at the l4/l5 level for the longissimus, intermuscular fascia and multifidus at baseline and during standardize weight bearing tasks as well as at recumbent baseline, during and return to neutral for prone and lateral recumbent continuous passive motion maneuvers.

  4. Change in tissue displacement and strains differ between healthy and unhealthy individuals when change in muscle activity and tissue layer are taken into account.

    • Assess any differences in displacement and strain characteristics of the layered longissimus, intermuscular fascia and multifidus between healthy and chronic low back patients in the timing relationship to movement, total passive load amplitudes and myoelectric activity.

Type d'étude

Observationnel

Inscription (Réel)

101

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2H 3J1
        • Canadian Memorial Chiropractic College

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Group 1: Fifteen healthy volunteers from Canadian Memorial Chiropractic College (CMCC) community.

Group 2: 30 Subjects (15 healthy volunteers and 15 chronic low back pain)

La description

Inclusion Criteria:

  • 18-45 years old
  • a clean history
  • no episode of disabling back pain
  • no episode of disabling leg pain
  • no episode within the prior 90 days will be required Back Pain Subjects
  • experiencing continuous episodes of low back pain within the prior 90 days
  • experiencing recurring episodes of low back pain within the prior 90 days
  • have pain at >3.0 on Visual Analogue Scale

Exclusion Criteria:

  • history of diabetes
  • history of neuromuscular disease
  • history of scoliosis apparent on inspection
  • a bleeding disorder
  • collagen vascular disease
  • corticosteroid therapy
  • extensive scarring or dermatological abnormalities, including adhesive tape sensitivity
  • women who are pregnant or have active menstruation will be excluded to avoid positional discomfort.
  • pain radiating below the knee or loss of motor, bowel or bladder control

Volunteers taking anti-inflammatory or antihistamine medications will be asked to discontinue their use 3 days before testing.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The quantitative tissue displacement and strains.
Délai: baseline and 6 weeks
These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.
baseline and 6 weeks
Timing of change in the relative myoelectric activity.
Délai: baseline and 6 weeks
These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.
baseline and 6 weeks
Strain ratio in the context of a series of motions in upright/recumbent postures and in healthy/chronic low back pain volunteers.
Délai: baseline and 6 weeks
These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.
baseline and 6 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Canadian Memorial Chiropractic College

Les enquêteurs

  • Chercheur principal: John J. Triano, DC, PhD, Canadian Memorial Chiropractic College

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2007

Achèvement de l'étude (Réel)

1 décembre 2011

Dates d'inscription aux études

Première soumission

23 septembre 2010

Première soumission répondant aux critères de contrôle qualité

13 octobre 2010

Première publication (Estimation)

14 octobre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

25 septembre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2012

Dernière vérification

1 septembre 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 72152

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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