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Extending Ultrasound Elastography to Manual Treatment Methods

21. september 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

  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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

101

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The quantitative tissue displacement and strains.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2007

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

23. september 2010

Først indsendt, der opfyldte QC-kriterier

13. oktober 2010

Først opslået (Skøn)

14. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 72152

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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