Extending Ultrasound Elastography to Manual Treatment Methods

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT01221155
First received: September 23, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition
Back Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Extending Ultrasound Elastography to Manual Treatment Methods

Resource links provided by NLM:


Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • The quantitative tissue displacement and strains. [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Timing of change in the relative myoelectric activity. [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Strain ratio in the context of a series of motions in upright/recumbent postures and in healthy/chronic low back pain volunteers. [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 101
Study Start Date: December 2007
Study Completion Date: December 2011
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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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)

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221155

Locations
Canada, Ontario
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada, M2H 3J1
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Investigators
Principal Investigator: John J. Triano, DC, PhD Canadian Memorial Chiropractic College
  More Information

No publications provided

Responsible Party: Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01221155     History of Changes
Other Study ID Numbers: 72152
Study First Received: September 23, 2010
Last Updated: September 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Memorial Chiropractic College:
Musculoskeletal

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014