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CompletedNCT01221155Updated Sep 25, 2012

Extending Ultrasound Elastography to Manual Treatment Methods

An observational study in Back Pain, sponsored by Canadian Memorial Chiropractic College. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-25.

Sponsored by Canadian Memorial Chiropractic College · Observational

Study type
Observational
Model
Cohort
Enrollment
101
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description
  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.
02

Conditions studied

  • Back Pain

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Keywords

  • Musculoskeletal
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 101 is close to the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Canadian Memorial Chiropractic College is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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)

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

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.

05

Study design

Observational model
Cohort
Enrollment
101 participants (actual)
06

What researchers measure

Primary outcomes

  1. The quantitative tissue displacement and strains.

    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.

    Time frame: baseline and 6 weeks

  2. Timing of change in the relative myoelectric activity.

    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.

    Time frame: baseline and 6 weeks

  3. Strain ratio in the context of a series of motions in upright/recumbent postures and in healthy/chronic low back pain volunteers.

    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.

    Time frame: baseline and 6 weeks

07

Study locations

1 site
  • Canadian Memorial Chiropractic College
    Toronto, Ontario M2H 3J1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01221155
Lead sponsor
Canadian Memorial Chiropractic College
Responsible party
Sponsor
First posted
Oct 14, 2010
Start date
Dec 2007
Completion
Dec 2011
Last update
Sep 25, 2012

Study contacts

John J. Triano, DC, PhD
principal investigator · Canadian Memorial Chiropractic College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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