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Extending Ultrasound Elastography to Manual Treatment Methods

21 september 2012 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

  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.

Studietyp

Observationell

Inskrivning (Faktisk)

101

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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)

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The quantitative tissue displacement and strains.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Canadian Memorial Chiropractic College

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2007

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

23 september 2010

Först inskickad som uppfyllde QC-kriterierna

13 oktober 2010

Första postat (Uppskatta)

14 oktober 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 september 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 september 2012

Senast verifierad

1 september 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 72152

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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